Trial Outcomes & Findings for CURES: The Effect of Deep Curarisation and Reversal With Sugammadex on Surgical Conditions and Perioperative Morbidity (NCT NCT01748643)
NCT ID: NCT01748643
Last Updated: 2017-08-03
Results Overview
At the end of surgery, the view on the operating field will be graded by the surgeon using a 5-point rating scale: 1. Extremely poor 2. Poor 3. Acceptable 4. Good 5. Optimal
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h
Results posted on
2017-08-03
Participant Flow
Participant milestones
| Measure |
Deep Neuromuscular Blockade, Reversal With Sugammadex
a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is \> 0.9.
deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio \> 0.9.
|
Normal Neuromuscular Blockade, Reversal With Neostigmine
After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio \> 0.9.
normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is \> 0.9.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CURES: The Effect of Deep Curarisation and Reversal With Sugammadex on Surgical Conditions and Perioperative Morbidity
Baseline characteristics by cohort
| Measure |
Deep Neuromuscular Blockade, Reversal With Sugammadex
n=30 Participants
a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is \> 0.9.
deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio \> 0.9.
|
Normal Neuromuscular Blockade, Reversal With Neostigmine
n=30 Participants
After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio \> 0.9.
normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is \> 0.9.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
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Body Mass Index
|
40 kg/m2
STANDARD_DEVIATION 3 • n=99 Participants
|
41 kg/m2
STANDARD_DEVIATION 7 • n=107 Participants
|
41 kg/m2
STANDARD_DEVIATION 5 • n=206 Participants
|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 13 • n=99 Participants
|
42 years
STANDARD_DEVIATION 11 • n=107 Participants
|
41.6 years
STANDARD_DEVIATION 12.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Peak expiratory flow
|
314 L/min
STANDARD_DEVIATION 109 • n=99 Participants
|
276 L/min
STANDARD_DEVIATION 81 • n=107 Participants
|
295 L/min
STANDARD_DEVIATION 97 • n=206 Participants
|
|
Forced expiratory volume in 1 second
|
2.4 L/min
STANDARD_DEVIATION 0.9 • n=99 Participants
|
2.2 L/min
STANDARD_DEVIATION 0.6 • n=107 Participants
|
2.3 L/min
STANDARD_DEVIATION 0.7 • n=206 Participants
|
|
Forced vital capacity
|
3.0 L/min
STANDARD_DEVIATION 0.9 • n=99 Participants
|
2.7 L/min
STANDARD_DEVIATION 0.8 • n=107 Participants
|
2.8 L/min
STANDARD_DEVIATION 0.8 • n=206 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5hAt the end of surgery, the view on the operating field will be graded by the surgeon using a 5-point rating scale: 1. Extremely poor 2. Poor 3. Acceptable 4. Good 5. Optimal
Outcome measures
| Measure |
Deep Neuromuscular Blockade, Reversal With Sugammadex
n=30 Participants
a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is \> 0.9.
deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio \> 0.9.
|
Normal Neuromuscular Blockade, Reversal With Neostigmine
n=30 Participants
After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio \> 0.9.
normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is \> 0.9.
|
|---|---|---|
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Subjective Evaluation of the View on the Operating Field by the Surgeon
|
4.2 units on a scale
Standard Deviation 1.0
|
3.9 units on a scale
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5hThe number of intra-abdominal pressure rises \> 18cmH2O detected by the intra-abdominal CO2 insufflator.
Outcome measures
| Measure |
Deep Neuromuscular Blockade, Reversal With Sugammadex
n=30 Participants
a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is \> 0.9.
deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio \> 0.9.
|
Normal Neuromuscular Blockade, Reversal With Neostigmine
n=30 Participants
After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio \> 0.9.
normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is \> 0.9.
|
|---|---|---|
|
Number of Intra-abdominal Pressure Rises > 18cmH2O
|
0.2 number of intra-abdominal pressure rises
Standard Deviation 0.9
|
0.3 number of intra-abdominal pressure rises
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5hMeasured from the time of first skin incision to completion of skin closure.
Outcome measures
| Measure |
Deep Neuromuscular Blockade, Reversal With Sugammadex
n=30 Participants
a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is \> 0.9.
deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio \> 0.9.
|
Normal Neuromuscular Blockade, Reversal With Neostigmine
n=30 Participants
After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio \> 0.9.
normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is \> 0.9.
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|---|---|---|
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Duration of Surgery
|
61.3 minutes
Standard Deviation 15.1
|
70.6 minutes
Standard Deviation 20.8
|
SECONDARY outcome
Timeframe: Measured the day before surgery and 30min after completion of surgery (when the modified observer's assessment of alertness/sedation scale is 5 (Patient responds readily to name spoken in normal tone))Peak expiratory flow is measured with the Vitalograph® electronic portable peak flow meter. A mean of 3 measurements in the upright posture in bed before and after surgery will be used.
Outcome measures
| Measure |
Deep Neuromuscular Blockade, Reversal With Sugammadex
n=30 Participants
a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is \> 0.9.
deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio \> 0.9.
|
Normal Neuromuscular Blockade, Reversal With Neostigmine
n=30 Participants
After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio \> 0.9.
normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is \> 0.9.
|
|---|---|---|
|
Peak Expiratory Flow
|
51.3 percent change from baseline
Standard Deviation 31.6
|
51.5 percent change from baseline
Standard Deviation 19.0
|
SECONDARY outcome
Timeframe: Measured the day before surgery and 30min after completion of surgery (when the modified observer's assessment of alertness/sedation scale is 5 (Patient responds readily to name spoken in normal tone))Forced expiratory volume in 1 second is measured with the Vitalograph® electronic portable peak flow meter. A mean of 3 measurements in the upright posture in bed before and after surgery will be used.
Outcome measures
| Measure |
Deep Neuromuscular Blockade, Reversal With Sugammadex
n=30 Participants
a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is \> 0.9.
deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio \> 0.9.
|
Normal Neuromuscular Blockade, Reversal With Neostigmine
n=30 Participants
After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio \> 0.9.
normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is \> 0.9.
|
|---|---|---|
|
Forced Expiratory Volume in 1 Second
|
45.2 percent change from baseline
Standard Deviation 36.4
|
48.8 percent change from baseline
Standard Deviation 19.6
|
SECONDARY outcome
Timeframe: Measured the day before surgery and 30min after completion of surgery (when the modified observer's assessment of alertness/sedation scale is 5 (Patient responds readily to name spoken in normal tone))Forced vital capacity is measured with the Vitalograph® electronic portable peak flow meter. A mean of 3 measurements in the upright posture in bed before and after surgery will be used.
Outcome measures
| Measure |
Deep Neuromuscular Blockade, Reversal With Sugammadex
n=30 Participants
a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is \> 0.9.
deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio \> 0.9.
|
Normal Neuromuscular Blockade, Reversal With Neostigmine
n=30 Participants
After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio \> 0.9.
normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is \> 0.9.
|
|---|---|---|
|
Forced Vital Capacity
|
51.9 percent change from baseline
Standard Deviation 16.4
|
49.0 percent change from baseline
Standard Deviation 22.6
|
Adverse Events
Deep Neuromuscular Blockade, Reversal With Sugammadex
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Neuromuscular Blockade, Reversal With Neostigmine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place