Trial Outcomes & Findings for Esketamine Induction Intubation in ICU Patients. (NCT NCT05464979)
NCT ID: NCT05464979
Last Updated: 2026-07-21
Results Overview
Mean arterial pressure was recorded before induction, during induction, during intubation, and at 1, 5, 10, 30, and 60 minutes after tracheal intubation.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
80 participants
Primary outcome timeframe
From 5 minutes before induction through 60 minutes after tracheal intubation.
Results posted on
2026-07-21
Participant Flow
The trial was registered before enrollment on clinicaltrials.gov (NCT05464979) on July 14, 2022. This single-center, prospective, randomized, controlled pilot study was approved by the Ethics Committee of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (2022-0351-01), and it conforms to the provisions of the 1964 Helsinki Declaration. Written informed consent was obtained from all patients or surrogates.
Allergy to esketamine or midazolam; endotracheal tract required intubation without notsedative drugs; Patients with suspected elevated intracranial pressure; bradycardia (heart rate (HR) less than 50 beats / min) or atrioventricular block；Untreated or undertreated hyperthyroid patients; chronic kidney disease; severe chronic liver disease (child-Pugh: Grade C); alcohol or opioid dependence, mental illness, or severe cognitive impairment; pregnancy or lactation; lack of informed consent
Participant milestones
| Measure |
Conventional Intubation Group
Midazolam at 0.1mg/kg BW, fentanyl at 1ug/kg BW, rocuronium bromide at 0.6mg/kg BW was given intravenously for induction intubation; After the intubation was completed, Sufentanil citrate (0.08-0.15 μg/kg/h) combined with remimazolam besylate (0.15-0.25 mg/kg/h) was administered intravenously to sustain a Critical-Care Pain Observation Tool (CPOT) score 0 and a Richmond Agitation and Sedation Scale (RASS) score between -3 and 0 following intubation.
midazolam, fentanyl: Midazolam at 0.1mg/kg BW, fentanyl at 1ug/kg BW, rocuronium bromide at 0.6mg/kg BW was given intravenously for induction intubation; After the intubation was completed, After the intubation was completed, Sufentanil citrate (0.08-0.15 μg/kg/h) combined with remimazolam besylate (0.15-0.25 mg/kg/h) was administered intravenously to sustain a Critical-Care Pain Observation Tool (CPOT) score 0 and a Richmond Agitation and Sedation Scale (RASS) score between -3 and 0 following intubation.
|
Esketamine Intubation Group
Esketamine at 0.5-1.0 mg/kg BW and rocuronium bromide at 0.6 mg/kg BW was given intravenously for induction intubation. After the intubation was completed, After the intubation was completed, Sufentanil citrate (0.08-0.15 μg/kg/h) combined with remimazolam besylate (0.15-0.25 mg/kg/h) was administered intravenously to sustain a Critical-Care Pain Observation Tool (CPOT) score 0 and a Richmond Agitation and Sedation Scale (RASS) score between -3 and 0 following intubation.
Esketamine Hydrochloride 28 Mg in 0.2 mL NASAL SOLUTION \[Spravato\]: Esketamine at 0.5-1.0 mg/kg BW and rocuronium bromide at 0.6 mg/kg BW was given intravenously for induction intubation. After the intubation was completed, After the intubation was completed, Sufentanil citrate (0.08-0.15 μg/kg/h) combined with remimazolam besylate (0.15-0.25 mg/kg/h) was administered intravenously to sustain a Critical-Care Pain Observation Tool (CPOT) score 0 and a Richmond Agitation and Sedation Scale (RASS) score between -3 and 0 following intubation.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Esketamine Induction Intubation in ICU Patients.
Baseline characteristics by cohort
| Measure |
Esketamine Intubation Group
n=38 Participants
Esketamine at 0.5-1.0 mg/kg BW and rocuronium bromide at 0.6 mg/kg BW was given intravenously for induction intubation. After the intubation was completed, sufentanil at 0.1 μg/kg/h was administered for analgesia, and remazolam tosylate at an initial dose of 0.075 mg/kg/h was administered for sedation, and the dose of remazolam tosylate was adjusted according to the RASS score. The RASS score was assessed every 1 h and maintained at -3 to 0.
Esketamine Hydrochloride 28 Mg in 0.2 mL NASAL SOLUTION \[Spravato\]: Esketamine at 0.5-1.0 mg/kg BW and rocuronium bromide at 0.6 mg/kg BW was given intravenously for induction intubation. After the intubation was completed, sufentanil at 0.1 μg/kg/h was administered for analgesia, and remazolam tosylate at an initial dose of 0.075 mg/kg/h was administered for sedation, and the dose of remazolam tosylate was adjusted according to the RASS score. The RASS score was assessed every 1 h and maintained at -3 to 0.
|
Conventional Intubation Group
n=42 Participants
Midazolam at 0.1mg/kg BW, fentanyl at 1ug/kg BW, rocuronium bromide at 0.6mg/kg BW was given intravenously for induction intubation; After the intubation was completed, sufentanil at 0.1 μg/kg/h was administered for analgesia, and remazolam tosylate at an initial dose of 0.075 mg/kg/h was administered for sedation, and the dose of remazolam tosylate was adjusted according to the RASS score. The RASS score was assessed every 1 h and maintained at -3 to 0.
midazolam, fentanyl: Midazolam at 0.1mg/kg BW, fentanyl at 1ug/kg BW, rocuronium bromide at 0.6mg/kg BW was given intravenously for induction intubation; After the intubation was completed, sufentanil at 0.1 μg/kg/h was administered for analgesia, and remazolam tosylate at an initial dose of 0.075 mg/kg/h was administered for sedation, and the dose of remazolam tosylate was adjusted according to the RASS score. The RASS score was assessed every 1 h and maintained at -3 to 0.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=9 Participants
|
37 Participants
n=27 Participants
|
72 Participants
n=267 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
|
Age, Continuous
|
59.0 years
n=9 Participants
|
66.5 years
n=27 Participants
|
64 years
n=267 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=9 Participants
|
10 Participants
n=27 Participants
|
18 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=9 Participants
|
32 Participants
n=27 Participants
|
62 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Asian
|
38 Participants
n=9 Participants
|
42 Participants
n=27 Participants
|
80 Participants
n=267 Participants
|
|
Region of Enrollment
China
|
38 participants
n=9 Participants
|
42 participants
n=27 Participants
|
80 participants
n=267 Participants
|
PRIMARY outcome
Timeframe: From 5 minutes before induction through 60 minutes after tracheal intubation.Mean arterial pressure was recorded before induction, during induction, during intubation, and at 1, 5, 10, 30, and 60 minutes after tracheal intubation.
Outcome measures
| Measure |
Esketamine Intubation Group
n=38 Participants
Esketamine at 0.5-1.0 mg/kg BW and rocuronium bromide at 0.6 mg/kg BW was given intravenously for induction intubation. After the intubation was completed, sufentanil citrate (0.08-0.15 μg/kg/h) combined with remimazolam besylate (0.15-0.25 mg/kg/h) was administered intravenously to sustain a Critical-Care Pain Observation Tool (CPOT) score 0 and a Richmond Agitation and Sedation Scale (RASS) score between -3 and 0 following intubation.
Esketamine Hydrochloride 28 Mg in 0.2 mL NASAL SOLUTION \[Spravato\]: Esketamine at 0.5-1.0 mg/kg BW and rocuronium bromide at 0.6 mg/kg BW was given intravenously for induction intubation. After the intubation was completed, esketamine was continuously pumped at 0.3-1.5 mg/kg/h to maintain sedation.
|
Conventional Intubation Group
n=42 Participants
Midazolam at 0.1mg/kg BW, fentanyl at 1ug/kg BW, rocuronium bromide at 0.6mg/kg BW was given intravenously for induction intubation; After the intubation was completed, sufentanil citrate (0.08-0.15 μg/kg/h) combined with remimazolam besylate (0.15-0.25 mg/kg/h) was administered intravenously to sustain a Critical-Care Pain Observation Tool (CPOT) score 0 and a Richmond Agitation and Sedation Scale (RASS) score between -3 and 0 following intubation.
midazolam, fentanyl: Midazolam at 0.1mg/kg BW, fentanyl at 1ug/kg BW, rocuronium bromide at 0.6mg/kg BW was given intravenously for induction intubation; After the intubation was completed, sufentanil at 0.1 μg/kg/h was administered for analgesia, and remazolam tosylate at an initial dose of 0.075 mg/kg/h was administered for sedation, and the dose of remazolam tosylate was adjusted according to the RASS score.
|
|---|---|---|
|
Mean Arterial Pressure Before, During, and After Tracheal Intubation
30 minutes after tracheal intubation
|
89 mm Hg
Standard Deviation 17
|
82 mm Hg
Standard Deviation 13
|
|
Mean Arterial Pressure Before, During, and After Tracheal Intubation
60 minutes after tracheal intubation
|
85 mm Hg
Standard Deviation 15
|
81 mm Hg
Standard Deviation 13
|
|
Mean Arterial Pressure Before, During, and After Tracheal Intubation
During intubation
|
101 mm Hg
Standard Deviation 20
|
92 mm Hg
Standard Deviation 21
|
|
Mean Arterial Pressure Before, During, and After Tracheal Intubation
1 minute after tracheal intubation
|
100 mm Hg
Standard Deviation 18
|
90 mm Hg
Standard Deviation 18
|
|
Mean Arterial Pressure Before, During, and After Tracheal Intubation
5 minutes after tracheal intubation
|
97 mm Hg
Standard Deviation 17
|
86 mm Hg
Standard Deviation 15
|
|
Mean Arterial Pressure Before, During, and After Tracheal Intubation
10 minutes after tracheal intubation
|
96 mm Hg
Standard Deviation 16
|
86 mm Hg
Standard Deviation 20
|
|
Mean Arterial Pressure Before, During, and After Tracheal Intubation
Baseline
|
87 mm Hg
Standard Deviation 16
|
95 mm Hg
Standard Deviation 20
|
|
Mean Arterial Pressure Before, During, and After Tracheal Intubation
During induction
|
94 mm Hg
Standard Deviation 17
|
81 mm Hg
Standard Deviation 19
|
PRIMARY outcome
Timeframe: From 5 minutes before induction through 60 minutes after tracheal intubation.Heart rate was recorded before induction, during induction, during intubation, and at 1, 5, 10, 30, and 60 minutes after tracheal intubation.
Outcome measures
| Measure |
Esketamine Intubation Group
n=38 Participants
Esketamine at 0.5-1.0 mg/kg BW and rocuronium bromide at 0.6 mg/kg BW was given intravenously for induction intubation. After the intubation was completed, sufentanil citrate (0.08-0.15 μg/kg/h) combined with remimazolam besylate (0.15-0.25 mg/kg/h) was administered intravenously to sustain a Critical-Care Pain Observation Tool (CPOT) score 0 and a Richmond Agitation and Sedation Scale (RASS) score between -3 and 0 following intubation.
Esketamine Hydrochloride 28 Mg in 0.2 mL NASAL SOLUTION \[Spravato\]: Esketamine at 0.5-1.0 mg/kg BW and rocuronium bromide at 0.6 mg/kg BW was given intravenously for induction intubation. After the intubation was completed, esketamine was continuously pumped at 0.3-1.5 mg/kg/h to maintain sedation.
|
Conventional Intubation Group
n=42 Participants
Midazolam at 0.1mg/kg BW, fentanyl at 1ug/kg BW, rocuronium bromide at 0.6mg/kg BW was given intravenously for induction intubation; After the intubation was completed, sufentanil citrate (0.08-0.15 μg/kg/h) combined with remimazolam besylate (0.15-0.25 mg/kg/h) was administered intravenously to sustain a Critical-Care Pain Observation Tool (CPOT) score 0 and a Richmond Agitation and Sedation Scale (RASS) score between -3 and 0 following intubation.
midazolam, fentanyl: Midazolam at 0.1mg/kg BW, fentanyl at 1ug/kg BW, rocuronium bromide at 0.6mg/kg BW was given intravenously for induction intubation; After the intubation was completed, sufentanil at 0.1 μg/kg/h was administered for analgesia, and remazolam tosylate at an initial dose of 0.075 mg/kg/h was administered for sedation, and the dose of remazolam tosylate was adjusted according to the RASS score.
|
|---|---|---|
|
Heart Rate Before, During, and After Tracheal Intubation
Baseline
|
107 beats/min
Standard Deviation 25
|
112 beats/min
Standard Deviation 28
|
|
Heart Rate Before, During, and After Tracheal Intubation
During induction
|
112 beats/min
Standard Deviation 21
|
111 beats/min
Standard Deviation 28
|
|
Heart Rate Before, During, and After Tracheal Intubation
During intubation
|
117 beats/min
Standard Deviation 25
|
124 beats/min
Standard Deviation 27
|
|
Heart Rate Before, During, and After Tracheal Intubation
1 minute after tracheal intubation
|
116 beats/min
Standard Deviation 26
|
120 beats/min
Standard Deviation 27
|
|
Heart Rate Before, During, and After Tracheal Intubation
5 minutes after tracheal intubation
|
112 beats/min
Standard Deviation 25
|
117 beats/min
Standard Deviation 27
|
|
Heart Rate Before, During, and After Tracheal Intubation
10 minutes after tracheal intubation
|
109 beats/min
Standard Deviation 24
|
115 beats/min
Standard Deviation 27
|
|
Heart Rate Before, During, and After Tracheal Intubation
30 minutes after tracheal intubation
|
106 beats/min
Standard Deviation 24
|
112 beats/min
Standard Deviation 27
|
|
Heart Rate Before, During, and After Tracheal Intubation
60 minutes after tracheal intubation
|
103 beats/min
Standard Deviation 21
|
109 beats/min
Standard Deviation 24
|
PRIMARY outcome
Timeframe: From 5 minutes before induction through 60 minutes after tracheal intubation.Peripheral oxygen saturation was recorded before induction, during induction, during intubation, and at 1, 5, 10, 30, and 60 minutes after tracheal intubation.
Outcome measures
| Measure |
Esketamine Intubation Group
n=38 Participants
Esketamine at 0.5-1.0 mg/kg BW and rocuronium bromide at 0.6 mg/kg BW was given intravenously for induction intubation. After the intubation was completed, sufentanil citrate (0.08-0.15 μg/kg/h) combined with remimazolam besylate (0.15-0.25 mg/kg/h) was administered intravenously to sustain a Critical-Care Pain Observation Tool (CPOT) score 0 and a Richmond Agitation and Sedation Scale (RASS) score between -3 and 0 following intubation.
Esketamine Hydrochloride 28 Mg in 0.2 mL NASAL SOLUTION \[Spravato\]: Esketamine at 0.5-1.0 mg/kg BW and rocuronium bromide at 0.6 mg/kg BW was given intravenously for induction intubation. After the intubation was completed, esketamine was continuously pumped at 0.3-1.5 mg/kg/h to maintain sedation.
|
Conventional Intubation Group
n=42 Participants
Midazolam at 0.1mg/kg BW, fentanyl at 1ug/kg BW, rocuronium bromide at 0.6mg/kg BW was given intravenously for induction intubation; After the intubation was completed, sufentanil citrate (0.08-0.15 μg/kg/h) combined with remimazolam besylate (0.15-0.25 mg/kg/h) was administered intravenously to sustain a Critical-Care Pain Observation Tool (CPOT) score 0 and a Richmond Agitation and Sedation Scale (RASS) score between -3 and 0 following intubation.
midazolam, fentanyl: Midazolam at 0.1mg/kg BW, fentanyl at 1ug/kg BW, rocuronium bromide at 0.6mg/kg BW was given intravenously for induction intubation; After the intubation was completed, sufentanil at 0.1 μg/kg/h was administered for analgesia, and remazolam tosylate at an initial dose of 0.075 mg/kg/h was administered for sedation, and the dose of remazolam tosylate was adjusted according to the RASS score.
|
|---|---|---|
|
Peripheral Oxygen Saturation Before, During, and After Tracheal Intubation
Baseline
|
92 percent oxygen saturation
Inter-Quartile Range 20 • Interval 83.0 to 97.0
|
93 percent oxygen saturation
Inter-Quartile Range 12 • Interval 88.0 to 96.0
|
|
Peripheral Oxygen Saturation Before, During, and After Tracheal Intubation
During induction
|
96 percent oxygen saturation
Interval 93.0 to 99.0
|
95 percent oxygen saturation
Interval 92.0 to 98.0
|
|
Peripheral Oxygen Saturation Before, During, and After Tracheal Intubation
During intubation
|
95 percent oxygen saturation
Interval 91.0 to 98.0
|
95 percent oxygen saturation
Interval 93.0 to 97.0
|
|
Peripheral Oxygen Saturation Before, During, and After Tracheal Intubation
1 minute after tracheal intubation
|
98 percent oxygen saturation
Interval 92.0 to 100.0
|
98 percent oxygen saturation
Interval 94.0 to 99.0
|
|
Peripheral Oxygen Saturation Before, During, and After Tracheal Intubation
5 minutes after tracheal intubation
|
99 percent oxygen saturation
Interval 95.0 to 100.0
|
98 percent oxygen saturation
Interval 95.0 to 99.0
|
|
Peripheral Oxygen Saturation Before, During, and After Tracheal Intubation
10 minutes after tracheal intubation
|
99 percent oxygen saturation
Interval 95.0 to 100.0
|
98 percent oxygen saturation
Interval 95.0 to 99.0
|
|
Peripheral Oxygen Saturation Before, During, and After Tracheal Intubation
30 minutes after tracheal intubation
|
99 percent oxygen saturation
Interval 96.0 to 100.0
|
99 percent oxygen saturation
Interval 94.0 to 100.0
|
|
Peripheral Oxygen Saturation Before, During, and After Tracheal Intubation
60 minutes after tracheal intubation
|
99 percent oxygen saturation
Interval 96.0 to 100.0
|
99 percent oxygen saturation
Interval 96.0 to 100.0
|
SECONDARY outcome
Timeframe: From induction through 1 hour after tracheal intubation.Norepinephrine infusion dose was summarized for each participant over the interval from induction through 1 hour after tracheal intubation. The reported value represents the participant-level average infusion rate during this interval.
Outcome measures
| Measure |
Esketamine Intubation Group
n=38 Participants
Esketamine at 0.5-1.0 mg/kg BW and rocuronium bromide at 0.6 mg/kg BW was given intravenously for induction intubation. After the intubation was completed, sufentanil citrate (0.08-0.15 μg/kg/h) combined with remimazolam besylate (0.15-0.25 mg/kg/h) was administered intravenously to sustain a Critical-Care Pain Observation Tool (CPOT) score 0 and a Richmond Agitation and Sedation Scale (RASS) score between -3 and 0 following intubation.
Esketamine Hydrochloride 28 Mg in 0.2 mL NASAL SOLUTION \[Spravato\]: Esketamine at 0.5-1.0 mg/kg BW and rocuronium bromide at 0.6 mg/kg BW was given intravenously for induction intubation. After the intubation was completed, esketamine was continuously pumped at 0.3-1.5 mg/kg/h to maintain sedation.
|
Conventional Intubation Group
n=42 Participants
Midazolam at 0.1mg/kg BW, fentanyl at 1ug/kg BW, rocuronium bromide at 0.6mg/kg BW was given intravenously for induction intubation; After the intubation was completed, sufentanil citrate (0.08-0.15 μg/kg/h) combined with remimazolam besylate (0.15-0.25 mg/kg/h) was administered intravenously to sustain a Critical-Care Pain Observation Tool (CPOT) score 0 and a Richmond Agitation and Sedation Scale (RASS) score between -3 and 0 following intubation.
midazolam, fentanyl: Midazolam at 0.1mg/kg BW, fentanyl at 1ug/kg BW, rocuronium bromide at 0.6mg/kg BW was given intravenously for induction intubation; After the intubation was completed, sufentanil at 0.1 μg/kg/h was administered for analgesia, and remazolam tosylate at an initial dose of 0.075 mg/kg/h was administered for sedation, and the dose of remazolam tosylate was adjusted according to the RASS score.
|
|---|---|---|
|
Norepinephrine Infusion Dose During Induction and Within 1 Hour After Intubation
|
0.00 micrograms/kilogram/min
Interval 0.0 to 0.01
|
0.09 micrograms/kilogram/min
Interval 0.0 to 0.29
|
SECONDARY outcome
Timeframe: From inclusion until discontinuation of invasive ventilator support.Duration of invasive ventilator support was measured from inclusion until discontinuation of invasive ventilator support.
Outcome measures
| Measure |
Esketamine Intubation Group
n=38 Participants
Esketamine at 0.5-1.0 mg/kg BW and rocuronium bromide at 0.6 mg/kg BW was given intravenously for induction intubation. After the intubation was completed, sufentanil citrate (0.08-0.15 μg/kg/h) combined with remimazolam besylate (0.15-0.25 mg/kg/h) was administered intravenously to sustain a Critical-Care Pain Observation Tool (CPOT) score 0 and a Richmond Agitation and Sedation Scale (RASS) score between -3 and 0 following intubation.
Esketamine Hydrochloride 28 Mg in 0.2 mL NASAL SOLUTION \[Spravato\]: Esketamine at 0.5-1.0 mg/kg BW and rocuronium bromide at 0.6 mg/kg BW was given intravenously for induction intubation. After the intubation was completed, esketamine was continuously pumped at 0.3-1.5 mg/kg/h to maintain sedation.
|
Conventional Intubation Group
n=42 Participants
Midazolam at 0.1mg/kg BW, fentanyl at 1ug/kg BW, rocuronium bromide at 0.6mg/kg BW was given intravenously for induction intubation; After the intubation was completed, sufentanil citrate (0.08-0.15 μg/kg/h) combined with remimazolam besylate (0.15-0.25 mg/kg/h) was administered intravenously to sustain a Critical-Care Pain Observation Tool (CPOT) score 0 and a Richmond Agitation and Sedation Scale (RASS) score between -3 and 0 following intubation.
midazolam, fentanyl: Midazolam at 0.1mg/kg BW, fentanyl at 1ug/kg BW, rocuronium bromide at 0.6mg/kg BW was given intravenously for induction intubation; After the intubation was completed, sufentanil at 0.1 μg/kg/h was administered for analgesia, and remazolam tosylate at an initial dose of 0.075 mg/kg/h was administered for sedation, and the dose of remazolam tosylate was adjusted according to the RASS score.
|
|---|---|---|
|
Duration of Invasive Ventilator Support
|
105.3 hours
Interval 40.9 to 248.3
|
211.5 hours
Interval 122.1 to 542.1
|
SECONDARY outcome
Timeframe: From inclusion until discharge from the intensive care unit, assessed up to 28 days after inclusion.Length of intensive care unit stay was measured from inclusion until discharge from the intensive care unit.
Outcome measures
| Measure |
Esketamine Intubation Group
n=38 Participants
Esketamine at 0.5-1.0 mg/kg BW and rocuronium bromide at 0.6 mg/kg BW was given intravenously for induction intubation. After the intubation was completed, sufentanil citrate (0.08-0.15 μg/kg/h) combined with remimazolam besylate (0.15-0.25 mg/kg/h) was administered intravenously to sustain a Critical-Care Pain Observation Tool (CPOT) score 0 and a Richmond Agitation and Sedation Scale (RASS) score between -3 and 0 following intubation.
Esketamine Hydrochloride 28 Mg in 0.2 mL NASAL SOLUTION \[Spravato\]: Esketamine at 0.5-1.0 mg/kg BW and rocuronium bromide at 0.6 mg/kg BW was given intravenously for induction intubation. After the intubation was completed, esketamine was continuously pumped at 0.3-1.5 mg/kg/h to maintain sedation.
|
Conventional Intubation Group
n=42 Participants
Midazolam at 0.1mg/kg BW, fentanyl at 1ug/kg BW, rocuronium bromide at 0.6mg/kg BW was given intravenously for induction intubation; After the intubation was completed, sufentanil citrate (0.08-0.15 μg/kg/h) combined with remimazolam besylate (0.15-0.25 mg/kg/h) was administered intravenously to sustain a Critical-Care Pain Observation Tool (CPOT) score 0 and a Richmond Agitation and Sedation Scale (RASS) score between -3 and 0 following intubation.
midazolam, fentanyl: Midazolam at 0.1mg/kg BW, fentanyl at 1ug/kg BW, rocuronium bromide at 0.6mg/kg BW was given intravenously for induction intubation; After the intubation was completed, sufentanil at 0.1 μg/kg/h was administered for analgesia, and remazolam tosylate at an initial dose of 0.075 mg/kg/h was administered for sedation, and the dose of remazolam tosylate was adjusted according to the RASS score.
|
|---|---|---|
|
Length of Intensive Care Unit Stay
|
7.0 days
Interval 4.0 to 16.3
|
15.0 days
Interval 8.0 to 26.0
|
SECONDARY outcome
Timeframe: Up to 28 days after inclusion.Mortality was assessed within 28 days after inclusion.
Outcome measures
| Measure |
Esketamine Intubation Group
n=38 Participants
Esketamine at 0.5-1.0 mg/kg BW and rocuronium bromide at 0.6 mg/kg BW was given intravenously for induction intubation. After the intubation was completed, sufentanil citrate (0.08-0.15 μg/kg/h) combined with remimazolam besylate (0.15-0.25 mg/kg/h) was administered intravenously to sustain a Critical-Care Pain Observation Tool (CPOT) score 0 and a Richmond Agitation and Sedation Scale (RASS) score between -3 and 0 following intubation.
Esketamine Hydrochloride 28 Mg in 0.2 mL NASAL SOLUTION \[Spravato\]: Esketamine at 0.5-1.0 mg/kg BW and rocuronium bromide at 0.6 mg/kg BW was given intravenously for induction intubation. After the intubation was completed, esketamine was continuously pumped at 0.3-1.5 mg/kg/h to maintain sedation.
|
Conventional Intubation Group
n=42 Participants
Midazolam at 0.1mg/kg BW, fentanyl at 1ug/kg BW, rocuronium bromide at 0.6mg/kg BW was given intravenously for induction intubation; After the intubation was completed, sufentanil citrate (0.08-0.15 μg/kg/h) combined with remimazolam besylate (0.15-0.25 mg/kg/h) was administered intravenously to sustain a Critical-Care Pain Observation Tool (CPOT) score 0 and a Richmond Agitation and Sedation Scale (RASS) score between -3 and 0 following intubation.
midazolam, fentanyl: Midazolam at 0.1mg/kg BW, fentanyl at 1ug/kg BW, rocuronium bromide at 0.6mg/kg BW was given intravenously for induction intubation; After the intubation was completed, sufentanil at 0.1 μg/kg/h was administered for analgesia, and remazolam tosylate at an initial dose of 0.075 mg/kg/h was administered for sedation, and the dose of remazolam tosylate was adjusted according to the RASS score.
|
|---|---|---|
|
Number of Participants Who Died Within 28 Days After Inclusion
|
9 Participants
|
11 Participants
|
Adverse Events
Esketamine Intubation Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 9 deaths
Conventional Intubation Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 11 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jiancheng Zhang, Dr.
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Phone: +8613554105815
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place