| Methods |
Single center, randomised, controlled trial
1) Allocation concealment: Unclear/Not stated
2) Blinding of patients: No
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: Yes |
| Participants |
Number of eligible patients: 86
Number of patients enrolled: 66
Drop outs/Withdrawals: 0
Incl. Criteria: Consecutive patients undergoing routine day‐case colonoscopy
Excl. Criteria: 1) Age less than 18 years 2) Severe pre‐existing cardiovascular or respiratory disease 3) Those felt to be unable to use the PCS system
Country: UK
Setting: Outpatient
Age(median(range) )(yrs): Group A: 50 52 (23‐74) Group B: (29‐73)
N (%) males: Not stated
ASA score: Not stated
Groups comparable at baseline: Yes (age, body weight, performance of pre‐procedure number connection test) |
| Interventions |
Group A (n=33): PCS Propofol (Median dose: 105 mg) and Alfentanil (Median dose: 0.13 mg)
Group B (n=33): Diazemul (Median (range) dose: 15 (10‐20) mg) and Pethidine: single bolus dose of 50 mg
Mode of administration: Group A: PCS boluses Group B: single bolus at beginning of procedure
Administered by: Group A: PCS Group B: endoscopist; All patients monitored by anaesthetists
Goal level of sedation: Group A (PCS): relieve any discomfort Group B: Not stated
All received supplemental oxygen (2 L/min) through nasal cannula |
| Outcomes |
Procedure time, patients' level of sedation, pain, complications, recovery time, patient satisfaction |
| Notes |
Definitions:
1) Patients' level of sedation, measured by a single nurse specialist during the procedure on a 5 point scale
2) Pain score: Patients' recollection, after recovery on a 4 point scale (also measured by a single nurse specialist during the procedure)
3) Recovery time: measured by comparison of number connection tests (NCTs) completed at 10‐min intervals after completion of the procedure with the NCT undertaken prior to sedation.
4) Complications: Maximum fall in systolic blood pressure, difference in O2 saturation, O2 desaturation less than 95%
5) Overall patient satisfaction: not defined |
