Trial Outcomes & Findings for Sedation Using Intranasal Dexmedetomidine in Upper Gastrointestinal Endoscopy (NCT NCT01887184)
NCT ID: NCT01887184
Last Updated: 2024-07-11
Results Overview
Until the removal of the endoscopy from the patients
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
50 participants
Primary outcome timeframe
Up to 30 minutes during gastrointestinal endoscopy
Results posted on
2024-07-11
Participant Flow
Participant milestones
| Measure |
Normal Saline
Normal saline was given intranasally
Placebo: Intranasal saline was given
|
Dexmedetomidine
1.5mcg dexmedetomidine was given intranasally before procedure
Dexmedetomidine: Dexmedetomidine 1.5mcg/kg was given intranasally
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sedation Using Intranasal Dexmedetomidine in Upper Gastrointestinal Endoscopy
Baseline characteristics by cohort
| Measure |
Normal Saline
n=25 Participants
Normal saline was given intranasally
Placebo: Intranasal saline was given
|
Dexmedetomidine
n=25 Participants
1.5mcg dexmedetomidine was given intranasally before procedure
Dexmedetomidine: Dexmedetomidine 1.5mcg/kg was given intranasally
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
43 years
STANDARD_DEVIATION 11.7 • n=99 Participants
|
41.7 years
STANDARD_DEVIATION 11.7 • n=107 Participants
|
42.4 years
STANDARD_DEVIATION 0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Region of Enrollment
Hong Kong
|
25 participants
n=99 Participants
|
25 participants
n=107 Participants
|
50 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 30 minutes during gastrointestinal endoscopyUntil the removal of the endoscopy from the patients
Outcome measures
| Measure |
Normal Saline
n=25 Participants
Normal saline was given intranasally
Placebo: Intranasal saline was given
|
Dexmedetomidine
n=25 Participants
1.5mcg dexmedetomidine was given intranasally before procedure
Dexmedetomidine: Dexmedetomidine 1.5mcg/kg was given intranasally
|
|---|---|---|
|
Consumption of Rescue Patient Controlled Propofol
|
42.4 mg
Standard Deviation 23.5
|
28.6 mg
Standard Deviation 23.9
|
SECONDARY outcome
Timeframe: Up to 24 hours after Upper EndoscopyPopulation: Number of participants required vasopressors or anticholinergic support due to decreases in perioperative haemodynamic parameters.
Patients were asked the side effects up to 24 hours after upper endoscopy.
Outcome measures
| Measure |
Normal Saline
n=25 Participants
Normal saline was given intranasally
Placebo: Intranasal saline was given
|
Dexmedetomidine
n=25 Participants
1.5mcg dexmedetomidine was given intranasally before procedure
Dexmedetomidine: Dexmedetomidine 1.5mcg/kg was given intranasally
|
|---|---|---|
|
Side Effects of Intrananasal Dexmedetomidine
|
0 Participants
|
0 Participants
|
Adverse Events
Normal Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexmedetomidine
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