CompletedPhase 4ACTRN12615000625572

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)


Sponsor

Usha Gurunathan

Enrollment

400 participants

Start Date

Sep 15, 2015

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • Adult patients undergoing elective outpatient colonoscopy

Exclusion Criteria7

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

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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 wit

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.


Locations(2)

The Prince Charles Hospital - Chermside

QLD, Australia

Royal Melbourne Hospital - City campus - Parkville

QLD, Australia

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ACTRN12615000625572