| CTRI Number |
CTRI/2024/08/072706 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
16/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
a clinical trial to study efficacy of two different doses of melatonin for anxiety alleviation in pre-operative patients |
|
Scientific Title of Study
|
Comparison of two doses of melatonin for preoperative anxiolysis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suneet Kant Kathuria |
| Designation |
Professor and Head, Department of Anaesthesiology |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia, Dayanand Medical College and Hospital, Civil lines, Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9814007622 |
| Fax |
|
| Email |
suneetkathuria@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anshita Gupta |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia, Dayanand Medical College and Hospita, Civil lines,Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9501437656 |
| Fax |
|
| Email |
anshitagupta97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anshita Gupta |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayandnd Medical College and Hospital |
| Address |
Department of Anaesthesia, Dayanand Medical College and Hospital, Civil lines, Ludhiana
Ludhiana
PUNJAB
144001
India |
| Phone |
9501437656 |
| Fax |
|
| Email |
anshitagupta97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand medical college and hospital, civil lines,ludhiana, Punjab, India
141001 |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College and Hospital |
| Address |
Civil lines, ludhiana, Punjab, India 141001 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Suneet Kant Kathuria |
Dayanand Medcial College and Hospital |
Department of Anesthesiology
Ludhiana
PUNJAB |
9814007622
suneetkathuria@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethics committee of Dayanand Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: 8||Other Procedures, (4) ICD-10 Condition: 8||Other Procedures, (5) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Melatonin 3mg |
Patints in group M3 will receive 3mg of oral melatonin 90 minutes before induction of general anaesthesia |
| Comparator Agent |
Melatonin 5mg |
Patients of group M5 will receive 5 mg oral melatonin 90 minutes before induction of general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA I & II
2. Patients posted for elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1.ASA physical status III and IV
2.Patients with Trait Anxiety Score STAI-T more than 45 during preanaesthetic checkup
3.Patients with known allergy to melatonin
4.Obese patients BMI more than 30 kg/m2
5.Patients already taking sedatives, anti psychotics, anxiolytics, anti epileptics
6.Pregnant and lactating mothers
7.Patient’s refusal to participate in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| STAI-S score at 90 minutes after drug administration in the two groups. |
90 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.STAI-S score, at the time of preanaesthetic check-up and just before administration of the study drug with in each group.
2.NRS-A score at 90 minutes after drug administration in the two groups.
3.RSS score at 90 minutes after drug administration in the two groups.
|
90 minutes |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Preoperative anxiety is described as an unpleasant state of tension or uneasiness that results from a patient’s doubts or fears about the surgery and anaesthesia. It has deleterious effects on intraoperative hemodynamic stability, requirement of anaesthesia and analgesia, post-operative pain, prolonged hospital stay, health care cost and may also increase morbidity and mortality. Melatonin (N-acetyl 5 methoxy tryptamine) is an endogenous hormone produced by the pineal gland. The primary physiological role of melatonin is to regulate the circadian rhythm. Melatonin has been studied in view of its preoperative anxiolytic and sedative effects due to its inhibitory action on central nervous system. However there is conflicting evidence on the effective and safe dose of melatonin required for preoperative anxiolysis.
|