| Methods |
Single center, randomised, controlled trial
1) Allocation concealment: Unclear/Not stated
2) Blinding of patients: Yes
3) Blinding of outcome assessors: Unclear/Not stated
4) A priori calculation of sample size: Yes
5) Groups treated identical other than the named intervention: Yes |
| Participants |
Number of eligible patients: 166
Number of patients enrolled: 150 (numbers in each group obtained from the first author)
Drop outs/Withdrawals: 0
Incl. Criteria: Consectutive patients scheduled for colonoscopy
Excl. Criteria: 1) Age below 18 or above 75 2) History of colonic resection 3) Allergy to study medication 4) Severe cardiorespiratory disease (ASA class III or higher) 5) Renal or hepatic impairment 6) Seizure disorder 7) Psychiatric disease 8) Substance abuse 9) Pregnancy or breast feeding 10) Refusal to receive any medication for the forthcoming colonoscopy
Country: Switzerland
Setting: Outpatient
Age(median(IQR) )(yrs): Group A: 55 (43‐63) Group B: 55 (40‐65) Group C: 48 (35‐64)
% males: Group A: 56 Group B: 44 Group C: 54
ASA score: I or II
Groups comparable at baseline: Yes (age, sex ratio, education, prior colonoscopy with or without sedation, pre‐colonoscopy anxiety) |
| Interventions |
Group A (n=50): PCS with Propofol (median(IQR) dose: 78 (57‐119) mg) and Alfentanil ( 198 (144‐300) micrograms)
Group B (n=50): Continous infusion of Propofol (median(IQR) dose: 90 (68‐131) mg) and Alfentanil ( 227 (173‐331) micrograms)
Group C (n=50): Midazolam (median(IQR) dose: 2.7 (2.3‐3.0) mg) and Meperidine ( 27(23‐30)mg)
Mode of administration: Groups A and C:bolus Group B: continuous infusion
Administered by: nurse, supervised by endoscopist
Goal level of sedation: Patient comfort
All received supplemental oxygen (2 L/min) through nasal cannula |
| Outcomes |
Primary outcome: patient satisfaction with the degree of sedation during colonoscopy
Secondary outcomes: pain, procedure time, amnesia, safety, recovery |
| Notes |
Definitions:
1) Patient satisfaction with the degree of sedation during colonoscopy: was measured 90 minutes after the procedure on a 10 cm VAS
2) Pain during procedure: 90 minutes after the procedure, patients asked to rate their pain during the procedure on a 10 cm VAS
3) Recovery from sedation: judged by Trieger dot‐joining test before, as well as 15, 45 and 90 minutes after colonoscopy
Data extraction combined for both the propofol groups |
