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

Phase 4

Completed

• Conditions: Cognitive recovery following anaesthesia; Anaesthesiology - Anaesthetics; Mental Health - Studies of normal psychology, cognitive function and behaviour; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12615000625572
• Lead Sponsor: sha Gurunathan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-16
• Study Completion: 2018-09-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 406

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of cognitive recovery as measured by Postoperative quality of recovery ( Postop QRS) questionnaire. The definition of recovery is a return to baseline values or better in all of the recovery domains, with adjustment for performance variability in the cognitive domain<br>The Postoperative Quality of Recovery Scale (PostopQRS) is a brief tool that has been widely used in many studies to assess quality of recovery in multiple domains at various time points. The final version of PostopQRS consists of six domains (physiologic, nociceptive, emotive, activities of daily living, cognitive and ‘overall patient perspective’). [Day 3 following procedure]

Secondary Outcome Measures

Name	Time	Method
Recovery for all domains (physiological, nociceptive, emotive activities of daily living, cognitive) and within domains over time and overall patient perspective as measured by PostopQRS questionnaire[15 minutes and 40 minutes, day 1, day 3, day 7 and 3 months following colonoscopy ]