| Methods |
Single center, randomised, controlled trial
1) Allocation concealment: Inadequate
2) Blinding of patients: Yes
3) Blinding of outcome assessors: Yes for a) examiners performing the neuropsychological testing and assessing patient wakefulness b) recovery room nurses
No for endoscopists and nurses administrating sedation
4) A priori calculation of sample size: Unclear/Not stated
5) Groups treated identical other than the named intervention: Yes |
| Participants |
Number of eligible patients: 82
Number of patients enrolled: 80
Drop outs/Withdrawals: 0
Incl. Criteria: Consectutive patients undergoing colonoscopy as out patients who were 1) 18 years of age or older 2) ASA class I or II 3) Scheduled to undergo colonoscopy alone
Excl. Criteria: 1) Patient desire to have colonoscopy without sedation 2) ASA class III or more 3) History of colonic or rectal resection 4) Sleep apnea 5) Enlarged tongue 6) Inability to widely open the mouth 7) Short thick neck 8) Known delayed gastric emptying 9) Acute gastrointestinal bleeding 10) Any neurological deficit 11) Pregnancy 12) Inability or unwillingness to give consent 13) Inpatient status 14) An allergy to either eggs or soy products or any of the sedative agents
Country: USA
Setting: Outpatient
Age(mean(SD) )(yrs): Group A: 51.7 (11.3) Group B: 54.2 (14.2)
N (%) males: Group A: 21 (52.5) Group B: 19 (47.5)
ASA score (mean(SD)): Group A: 1.25 (0.44) Group B: 1.3(0.46)
Groups comparable at baseline: Yes (age, sex ratio, body weight, race, education, alcohol intake, smoking, handedness, prior colonoscopy, ASA score) |
| Interventions |
Group A (n=40): Propofol (Mean (SD) dose: 214 (94) mg) Bolus administration
Group B (n=40): Midazolam (Mean(SD) dose: 4.7 (1.5) mg) and Meperidine: (Mean (SD) dose: 89.7(29.1)mg)
Mode of administration: Both groups‐bolus
Administered by: nurse, supervised by endoscopist
Goal level of sedation: Nurses instructed to induce a state that allowed patients to tolerate the procedure with minimal to mild pain, while maintaining adequate cardiorespiratory function
All received supplemental oxygen (4 L/min) through nasal cannula |
| Outcomes |
Primary outcomes: sedation time, recovery time, discharge time, patient satisfaction scores (10 cm VAS)
Secondary outcomes: procedure time, patients' level of sedation, pain, ability to cooperate, Complications (a decline in oxygen saturation <85%, HR< 50, BP < 90/50, need for mechanical ventilation), neuropsychological testing scores (before and after the colonoscopy) |
| Notes |
Before starting the study, the sequence of sedation treatments was created with a coin toss and blocks of 4. The block size of 4 may have been too small to prevent deciphering of sequence.
Definitions:
1) Full recovery defined as: systolic/diastolic BP and HR within 20% of baseline, O2 saturation >90% while breathing room air and ability to stand at bedside without instability or assistance
Recovery also defined as time to reach score of 5 on Observer's Assessment of Alertness/Sedation scale (data presented in figure only)
2) Discharge time: Recovery room nurses determined when patients could be discharged. The general criteria were: systolic/diastolic BP and HR within 20% of baseline, O2 saturation >90% while breathing room air, ability to walk without instability and ability to drink liquids
3) Sedation: Patients level of sedation measured on a 5 point scale. Nurses instructed to induce a state that allowed patients to tolerate the procedure with minimal to mild pain, while maintaining adequate cardiorespiratory function
4) Pain: Patients asked (after the procedure) to rate their pain during the procedure: None, Mild, Moderate, Severe. Data abstracted for meta‐analysis as Moderate/Severe Pain vs. No/Mild Pain
5) Patient Satisfaction: Patients completed a satisfaction questionnaire by using a visual 10‐cm analogue scale for "overall satisfaction with colonoscopy procedure" |
