| CTRI Number |
CTRI/2021/07/035284 [Registered on: 30/07/2021] Trial Registered Prospectively |
| Last Modified On: |
22/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study on the effects of commonly used pre operative anxiety reducing medicines midazolam and melatonin on cognition and psychomotor function |
|
Scientific Title of Study
|
A triple blinded randomised controlled trial on neurocognitive and psychomotor effects of melatonin versus midazolam when administered as preanaesthetic medication before surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSSreeRanjini |
| Designation |
Professor |
| Affiliation |
Bhaarath medical college hospital |
| Address |
Dept. of Anaesthesiology,
Bhaarath medical college hospital, 173, Agaram main road, selaiyur, chennai - 600073
173, Agaram main road, selaiyur, chennai - 600073
Kancheepuram
TAMIL NADU
600073
India |
| Phone |
9840770817 |
| Fax |
|
| Email |
anaesthesiology@bmch.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSSreeRanjini |
| Designation |
Professor |
| Affiliation |
Bhaarath medical college hospital |
| Address |
Dept. of Anaesthesiology,
Bhaarath medical college hospital, 173, Agaram main road, selaiyur, chennai - 600073
173, Agaram main road, selaiyur, chennai - 600073
Kancheepuram
TAMIL NADU
600073
India |
| Phone |
9840770817 |
| Fax |
|
| Email |
anaesthesiology@bmch.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DrSSreeRanjini |
| Designation |
Professor |
| Affiliation |
Bhaarath medical college hospital |
| Address |
Dept. of Anaesthesiology,
Bhaarath medical college hospital, 173, Agaram main road, selaiyur, chennai - 600073
173, Agaram main road, selaiyur, chennai - 600073
Kancheepuram
TAMIL NADU
600073
India |
| Phone |
9840770817 |
| Fax |
|
| Email |
anaesthesiology@bmch.ac.in |
|
|
Source of Monetary or Material Support
|
| Bhaarath Medical College Hospital, Selaiyur, Chennai |
|
|
Primary Sponsor
|
| Name |
Dr S SreeRanjini |
| Address |
bhaarath medical college hospital, chennai |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSreeRanjini |
Bhaarath medical college |
Pre operative holding room,Operation theatre complex, Department of Anaesthesiology,173, agaram main road, selaiyur, chennai -73
Kancheepuram
TAMIL NADU |
9840770817
anaesthesiology@bmch.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaarath Institutional ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: N218||Other lower urinary tract calculus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Oral melatonin |
given in standard dose of 0.1mg/kg only once as anxiolytic premedication. DSST and TMT tests are done pre drug and 1 hr post drug administration to see the neurocognitive and psychomotor effects. An accelerometer based device is strapped on to the wrist to see sedation depth as sleep score |
| Intervention |
oral midazolam, nasal midazolam, orobuccal melatonin, placebo sterile water oral |
one of the above drugs in standard dosage are given to the patient according to the group allocated only once, as an anxiolytic premedication. Midazolam dose 0.2mg/kg and melatonin 0.1mg/kg given only once. then DSST and TMT tests are done pre drug administration and one hour post administration to see neurocognitive and psychomotor effects. An accelerometer based device is strapped on to wrist to see sedation depth as sleep score |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult Patients of ASA – PS classification I and II status between 18 – 60 years of age undergoing any surgery requiring anaesthesia, education high school and above |
|
| ExclusionCriteria |
| Details |
Patients with ASA – PS classification III physical status or greater, Patients less than 18 years of age and more than 60 years of age, Unwilling patients, patients with psychiatric disorders on anti psychotic drugs, language or communication difficulties, sleep disorders, renal or hepatic derangement, low intelligence quotient, abnormalities of the right and left hands and inability to read and write basic alphabets,obstetric |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sedation
Orientation
Amnesia
Cognitive and psychomotor dysfunction
|
baseline status checked, that is before drug administration and rechecked one hour after drug administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Anxiolysis
• Adverse effects such as nausea, vomiting, hemodynamic disturbances etc
|
baseline status checked, that is before drug administration and rechecked one hour after drug administration |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
Final Enrollment numbers achieved (Total)= "165"
Final Enrollment numbers achieved (India)="165" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/08/2021 |
| Date of Study Completion (India) |
31/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Anxiety before surgery occurs commonly and if untreated, can lead to intra and post operative hemodynamic issues due to sympathetic overdrive, as well as higher chances of infection and delayed wound healing. Hence pre operative anxiolytic medications have to be given. But all these anxiolytics have effects on the cognition and psychomotor function; which can be detrimental in daycare surgery,older patients and susceptible population. So in this study, we plan to study the effects of commonly used anxiolytics namely midazolam (oral and intranasal) and melatonin (oral and orobuccal) in standard doses and their effect on neurocognitive and psychomotor functions. The hypothesis being oral melatonin will have the least effects on neurocognitive and psychomotor functions when compared to midazolam in any route. |