| Methods |
Single center, randomised, controlled trial
1) Allocation concealment: Unclear/Not stated
2) Blinding of patients: Yes
3) Blinding of outcome assessors: No
4) A priori calculation of sample size: Unclear/Not stated
5) Groups treated identical other than the named intervention: Unclear/Not stated |
| Participants |
Number of eligible patients: Not stated
Number of patients enrolled: 102
Drop outs/Withdrawals: 3
Incl. Criteria: In‐patients, who were 18 years of age or older
Excl. Criteria: Serious unrelated medical diseases
Country: Germany
Setting: Inpatient
Age(mean)(yrs): Group A: 55 Group B: 62
N (%) males: Group A: 21 (43) Group B: 25(50)
ASA score: Not stated
Groups comparable at baseline: Yes (age, sex ratio) |
| Interventions |
Group A (n=49): Propofol: Initial bolus 2.5 mg/kg body weight (for participants 18‐50 years age), 1.7 mg/kg (51‐74 years) or 1.1 mg/kg (75‐93 years). Subsequent infusion 6 mg/kg/hr (18‐50 years ), 4.5 mg/kg/hr (51‐74 years) or 3.8 mg/kg/hr (75‐93 years)
Group B (n=50): Midazolam: Maximum dose 12.5 mg
Mode of administration: Propofol: bolus followed by infusion Midazolam: bolus
Administration directed by endoscopist
Goal level of sedation: Slurred speech or lack of reaction (no response to verbal commands)
Supplemental oxygen (2 L/min through nasal cannula) administered if oxygen saturation dropped to <90% for more than 1 min |
| Outcomes |
Patients' level of sedation, pain, ability to cooperate, acceptability of procedure, antegrade amnesia, complications (a decline in oxygen saturation, drop in systolic and diastolic pressure, apnea) |
| Notes |
German language article
Patients likely blinded, although not explicitly stated in the study. It was stated that the study was single blinded.
Withdrawals: Data from three patients (2 in propofol group and 1 in midazolam) were not analysed in the study as they had to be given more than the prescribed medications
Definitions:
1) Patients' level of sedation: assessed after the initial bolus injection as awake, somnolent (reaction to verbal command) and asleep
2) Patients' ability to cooperate and acceptability of procedure graded by the endoscopists, immediately after the colonoscopy, on a 10 point scale
3) Pain: Patients asked ( 4 hrs after the procedure) to rate their pain during the procedure on a 10 point scale
4) Mean (and range) drop in systolic, diastolic pressures and O2 saturation provided |
