ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000625572

Ethics application status

Approved

Date submitted

27/05/2015

Date registered

16/06/2015

Date last updated

13/11/2018

Date data sharing statement initially provided

13/11/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1169-0229

Trial acronym

MIMiCRY

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cognitive recovery following anaesthesia

Condition category

Condition code

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

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

The control group will receive same volume of 0.9% saline as the volume of midazolam calculated according to the patient's body weight.

Control group

Placebo

Outcomes

Primary outcome [1]

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
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’).

Timepoint [1]

Day 3 following procedure

Secondary outcome [1]

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

Timepoint [1]

15 minutes and 40 minutes, day 1, day 3, day 7 and 3 months following colonoscopy

Eligibility

Key inclusion criteria

Adult patients undergoing elective outpatient colonoscopy

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key 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

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Adult patients undergoing colonoscopy at the Prince Charles Hospital will be recruited for this study prior to but on the day of the procedure. Letters to the patient informing about the study will be posted to the patient a few days before the surgery. These patients will be contacted either at the colon consent clinic or on the day of the procedure to sign the consent for the study. This is a parallel randomized trial with allocation ratio 1:1

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomization table will be produced using a computer generated randomization sequence. Concealment will be by placing the card containing the allocation information in double opaque sealed envelopes. A non-participant in any process of the study will perform preparation of the envelopes. Concealment will be maintained until after recruitment and patient is admitted for the procedure. A non-investigator medical or nursing staff/research coordinator will then open the envelopes to reveal the allocation. The trial preparation will be drawn in a syringe by a non-investigator anaesthetist or nurse, labeled as “trial drug” and documented as “trial drug” in the chart.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Safety

Statistical methods / analysis

Analysis of the primary endpoint will be performed using the chi-squared analysis for difference in the incidence of recovery in the cognitive domain at day 3. For recovery across all time points for each domain, the Cochran Mantel Haenszel test will be used to examine the difference in the proportions of recovery between the groups with continuity correction over the different time periods. Continuous data will be analysed using independent samples t test, or repeated measures ANOVA for repeated measurements. The level of significance will be defined as p<0.05. Based on the previous studies, the cognitive recovery on day 3 is around 70% in elderly patients. Considering that an absolute difference of 15% would constitute significant difference between groups and using a two-tailed design, a sample size of n= 174 per group will provide a power of 80% with an alpha value of 0.05. 400 patients will be recruited to compensate for the dropouts and loss to follow up.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

10/07/2015

Actual

15/09/2015

Date of last participant enrolment

Anticipated

31/07/2018

Actual

3/06/2018

Date of last data collection

Anticipated

Actual

3/09/2018

Sample size

Target

400

Accrual to date

Final

406

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

The Prince Charles Hospital - Chermside

Recruitment hospital [2]

Royal Melbourne Hospital - City campus - Parkville

Recruitment postcode(s) [1]

4032 - Chermside

Recruitment postcode(s) [2]

3050 - Parkville

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Prince Charles Hospital

Address [1]

Department of Anaesthesia, The Prince Charles Hospital, Rode Road, Chermside, QLD 4032

Country [1]

Australia

Primary sponsor type

Individual

Name

Usha Gurunathan

Address

Department of Anaesthesia, The Prince Charles Hospital, Rode Road, Chermside, QLD 4032

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Prince Charles Hospital Human Research and Ethics committee

Ethics committee address [1]

Rode Road, Chermside, QLD 4032

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/04/2015

Approval date [1]

02/06/2015

Ethics approval number [1]

HREC/15/QPCH/84

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Usha Gurunathan

Address

Department of Anaesthesia, The Prince Charles Hospital, Rode Road, Chermside, QLD 4032

Country

Australia

Phone

+61 7 3139 4000

Fax

usha.gurunathan@health.qld.gov.au

Contact person for public queries

Name

Usha Gurunathan

Address

Department of Anaesthesia, The Prince Charles Hospital, Rode Road, Chermside, QLD 4032

Country

Australia

Phone

+61 7 3139 4000

Fax

usha.gurunathan@health.qld.gov.au

Contact person for scientific queries

Name

Usha Gurunathan

Address

Department of Anaesthesia, The Prince Charles Hospital, Rode Road, Chermside, QLD 4032

Country

Australia

Phone

+61 7 3139 4000

Fax

usha.gurunathan@health.qld.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Individual participant data is not of much clinical utility with this trial.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effect of midazolam in addition to propofol and opiate sedation on the quality of recovery after colonoscopy: A randomized clinical trial.	2020	https://dx.doi.org/10.1213/ANE.0000000000004620

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically