Mandel 2006.
Methods | Single center, randomised, controlled trial 1) Allocation concealment: Adequate 2) Blinding of patients: Yes 3) Blinding of outcome assessors: Yes 4) A priori calculation of sample size: Yes 5) Groups treated identical other than the named intervention: Unclear/Not stated | |
Participants | Number of eligible patients: Not stated
Number of patients enrolled: 50
Drop outs/Withdrawals: 1(noncompliance with bowel preparation)
Incl. Criteria: Patients scheduled for elective outpatient colonoscopy with conscious sedation
Excl. Criteria: Not stated
Country: USA
Setting: Outpatient
Age(mean(SD) )(yrs): Group A: 60.5 (9.6) Group B: 57.7 (10.8)
N (%) males: Group A: 13 (52) Group B: 11(46) ASA score : Not provided for all patients (ASA score III: Groups A:2 and group B:1) Groups comparable at baseline: Yes (age, gender, BMI and number of ASA III patients) |
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Interventions | Group A (n=25): Propofol (10 mg/ml) and Remifentanil (10 micrograms/ml): Initial bolus of 2.5 ml with demand of 0.75 ml at zero lockout Group B (n=24): Midazolam (0.5 mg/ml) and Fentanyl (12.5 micrograms/ml): Initial bolus of 4 ml with demand of 1ml at 1' lockout Mode of administration: Both groups‐PCS boluses Administered by: PCS; anaesthesiologist present to intervene Goal level of sedation: Not stated All patients received supplemental oxygen (2 L/min) through nasal cannula | |
Outcomes | Procedure time, time to sedation, recovery time, SaO2 < 85% for 60", patient satisfaction | |
Notes | Block size of 10 for first ten cases and then 40 for the rest of the cases was used. No mention, whether the study was performed on adult patients, but the mean age and use of PCS suggests that patients were adults. Anesthesiologist intervention for oxygen desaturation recorded Definitions: 1) Patient, gastroenterologist and nurse satisfaction was assessed on a 7‐point Likert scale; however the results section does not provide the recorded scores. 2) Recovery time= time to ambulation‐time at removal of colonoscope; however the time reported in the study and abstracted by us is the "recovery room time", which was not explicitly defined in the study. 3) Procedure time=time between colonoscope removal and insertion. 4) Safety endpoints included: arterial desaturation (85% for more than 60 s); hypotension (90 mmHg systolic or 20% decrease from baseline persisting on repeat determination 1 min later )or inability to tolerate the procedure. 5) Time to sedation: time between insertion of the colonoscope and initiation of the sedation. |