| CTRI Number |
CTRI/2024/12/078503 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of oral melatonin as premedication on haemodynamic changes during laparoscopic cholecystectomy |
|
Scientific Title of Study
|
Effect of oral melatonin as premedication on haemodynamic changes during laparoscopic cholecystectomy - A randomized double blinded controlled trial |
| 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. Deepanshu Dhiman |
| Designation |
Assistant Professor |
| Affiliation |
Dr. Yashwant Singh parmar Government medical college and hospital , Nahan |
| Address |
Department of Anaesthesia,
Dr. Yashwant Singh Parmar Government Medical College and Hospital , Nahan, Sirmaur,
Himachal Pardesh
Sirmaur
HIMACHAL PRADESH
173001
India |
| Phone |
9646308822 |
| Fax |
|
| Email |
panshu88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Deepanshu Dhiman |
| Designation |
Assistant Professor |
| Affiliation |
Dr. yashwant sing parmar government medical collge and hospital , Nahan |
| Address |
Department of Anaesthesia,
Dr. yashwant singh parmar government medical college and hospital , Nahan, Sirmaur,
Himachal Pardesh
Sirmaur
HIMACHAL PRADESH
173001
India |
| Phone |
9646308822 |
| Fax |
|
| Email |
panshu88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Deepanshu Dhiman |
| Designation |
Assistant Professor |
| Affiliation |
Dr. Yashwant singh parmar government medical college and hospital , Nahan |
| Address |
Department of Anaesthesia,
Dr. Yashwant singh parmar government medical college and hospital , Nahan, Sirmaur,
Himachal Pardesh
Sirmaur
HIMACHAL PRADESH
173001
India |
| Phone |
9646308822 |
| Fax |
|
| Email |
panshu88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Yashwant singh parmar government medical college and hospital |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
N/A |
| Type of Sponsor |
Other [] |
|
|
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 |
| Deepanshu Dhiman |
Dr. Yashwant Singh Parmar Goveernment Medical college and Hopsital |
Operation theatre area, Department of AnaesthesiaDr. Yashwant Singh Parmar Goveernment Medical college and Hopsital
Sirmaur
HIMACHAL PRADESH |
09646308822
panshu88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
oral melatonin |
All patients in this group will receive oral melatonin tablet in a dose of 5 mg, 2 hours before induction of general anesthesia. |
| Comparator Agent |
oral multi-vitamin |
All patients in this group will receive oral multi-vitamin tablet identical looking tablets to melatonin, 2 hours before induction of general anesthesia. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
20-60 years old
ASA category I and II
BMI more than 18.5 and BMI less than 29.9
Patients undergoing elective cholecystectomy |
|
| ExclusionCriteria |
| Details |
1. Patients diagnosed with diabetes, hypertension, obesity, valvular heart disease, renal and hepatic impairment.
Patients on anticoagulants and antiplatelets.
Patients on other sedative hypnotic drugs.
Patients on antipsychotics, anxiolytics and antiepileptic.
Patients with sleep disorders. Patients with known drug allergy.
Patients on oral contraceptives, caffeine, fluvoxamine, oral hypoglycemic agents, immunosuppressants.
Patients on calcium channel blockers.
Patients with anticipated difficult airway.
Pregnant patients.
Contraindication to general anesthesia.
Patients anticipated to have surgical complications.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of oral melatonin on hemodynamic parameters which include heart rate, mean arterial pressure, systolic and diastolic blood pressure during intra-operative and post-operative up to 24 hours after surgery, in patients undergoing laparoscopic cholecystectomy under general anesthesia |
5 mins after intubation, 10 mins after intubation, before pneumoperitoneum, 5 mins after pneumoperitoneum till 30 mins after pneumoperitoneum and then after every 10 mins till patient is extubated. 1hr, 4hr, 8hr, 12hr,24hr, 36hr,48hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of oral melatonin on post-operative sedation score, visual analogue score for post operative pain and rescue analgesics received postoperatively up to 24 hours after surgery. |
1hour, 4hour, 8 hour, 12hour,24hour, 36 hour, 48 hour |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
03/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/01/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The following trail is a double blinded randomized control trail, which will compare the effect of oral melatonin given as premediction before surgery , the comparison with will be. control group which will receive multivitamin doses, the haemodynamic parameters will studied intraoperatively and post-operatively, and sedation, pain and VAS will be studied post recovery. the trail has been approved by institutional ethics committee. |