The effect of propofol or propofol plus midazolam and/or fentanyl on cognitive impairment following colonoscopy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000503527

Enrollment

200

Registered

2006-12-05

Start date

2006-12-06

Completion date

2008-02-22

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients having colonoscopy under sedation may remain sedated for some hours afterwards. This may mean that they cannot return to work inside or outside the home. Our hypothesis is that patients who receive midazolam and fentanyl, as well as propofol, will be more sedated than those who receive propofol alone, at the time of hospital discharge.

Interventions

2. Sedation individually titrated for patient requirement for the duration of colonoscopy (10-60 minutes) with variable dose intravenous propofol (50-400 mg) plus variable dose intravenous midazolam (0.5-5 mg) and/or variable dose intravenous fentanyl (10-100 mcg)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients who present for elective outpatient colonoscopy, not combined with other procedures and following full bowel preparation.

Exclusion criteria

Patients with cognitive deficits and without adequate English language comprehension.

Outcome results