Methods |
Single center, randomised, controlled trial
1) Allocation concealment: Unclear/Not stated
2) Blinding of patients: No
3) Blinding of outcome assessors: Yes
4) A priori calculation of sample size: Not stated
5) Groups treated identical other than the named intervention: Not stated |
Participants |
Number of eligible patients: Not stated
Number of patients enrolled: 29
Drop outs/Withdrawals: 0
Incl. Criteria: Not stated
Excl. Criteria: Not stated
Country: Spain
Setting: Ambulatory colonoscopy
Age(yrs):45‐75
N (%) males: Not stated
ASA score: Not stated
Groups comparable at baseline: Not stated |
Interventions |
Group A (n=14): Propofol (Mean dose: 191.79 mg)
Group B (n=15): Midazolam (Mean dose: 18.93 mg) and Flumazenil (Mean dose: 0.28 mg). All patients in this group received incremental doses of flumazenil, until awakening
Mode of administration: Both groups‐bolus
Administered by: Not stated
Goal level of sedation: Not stated
Administration of supplemental oxygen: Not stated |
Outcomes |
Recovery time, discharge time, post procedure amnesia, patient satisfaction, endoscopist satisfaction
Vitals and level of sedation during the procedure also measured |
Notes |
Abstract DDW 1994
Definitions:
1) Recovery time: time to sit, walk and get dressed measured. Time to get dressed used in the meta‐analysis.
2) Methodology for measuring other outcomes not given |