A randomized trial of midazolam versus placebo on cognitive recovery in adult patients following elective outpatient colonoscopy using postoperative quality of recovery scale.

A randomised trial of midazolam versus placebo on the quality of recovery after colonoscopy (MIMiCRY)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000625572

Acronym

MIMiCRY

Enrollment

406

Registered

2015-06-16

Start date

2015-09-15

Completion date

2018-06-03

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 undergoing day surgery procedures are usually discharged the same day. They are not assessed further unless they come back for follow up or they have some medical or surgical complications. The recovery from general anaesthesia can vary considerably between individuals. Due to paucity of randomized trials, it is unclear if the brief anaesthesia the patients receive for their surgery, can affect longer-term recovery (especially cognitive recovery). Midazolam, a short-acting benzodiazepine, enhances the action of gamma aminobutyric acid (GABA), thereby acting as a neural inhibitor. It increases binding of GABA to GABA-a receptors that are highly concentrated in hippocampus. It is widely used as anxiety relieving, sedative and as a premedicant. There are concerns about the residual effect of midazolam on the cognitive status of patients following its administration as a part of anaesthetic induction. In day surgery procedures, quality of recovery has profound implications for the individual patient and for the community, in terms of return to work and safe driving. An ideal anaesthetic for day surgery procedures should not affect the mental capabilities for a long period of time. Our objective is to identify if administering midazolam in addition to propofol affects the recovery of cognitive function in patients undergoing elective colonoscopy.

Interventions

Eligible and consented patients will be randomly allocated to receive an intravenous injection of 0.04 mg/kg (total body weight) upto a maximum of 5 mg midazolam immediately prior to the sedation with intravenous propofol.The dose of propofol will be titrated by the administering anaesthetist to a sedation level suitable to perform the procedure.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Adult patients undergoing elective outpatient colonoscopy

Exclusion criteria

1. History of psychiatric illness, neurological disease, visual or auditory disturbances 2. History of drug/alcohol abuse 3. History of preexisting memory or cognitive disturbance 4. Not fluent in English, sufficient to complete the PostopQRS survey. 5. Patient refusals or non-compliance 6. Clinically significant renal or hepatic dysfunction. 7. Significant cardiorespiratory instability

Outcome results