| CTRI Number |
CTRI/2025/04/084520 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Giving melatonin 2 hours before surgery to see its effects on blood pressure and heart rate in older patients. |
|
Scientific Title of Study
|
Effects of Oral Melatonin Premedication on Attenuation of Haemodynamic Response to Intubation and Anaesthetic Requirements in Geriatric Patients: A Randomized Clinical 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 |
Ria Tyagi |
| Designation |
Resident, MD Anaesthesia |
| Affiliation |
|
| Address |
Hamdard Institute of Medical Sciences and Research, Hamdard Nagar, New Delhi
South
DELHI
110062
India |
| Phone |
9560489361 |
| Fax |
|
| Email |
riatyagi98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pratibha Panjiar |
| Designation |
Professor, Department of Anaesthesia |
| Affiliation |
|
| Address |
Hamdard Institute of Medical Sciences and Research, Hamdard Nagar, New Delhi
South
DELHI
110062
India |
| Phone |
9311657822 |
| Fax |
|
| Email |
pratibha.panjiar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ria Tyagi |
| Designation |
Resident, MD Anaesthesia |
| Affiliation |
|
| Address |
Hamdard Institute of Medical Sciences and Research, Hamdard Nagar, New Delhi
South
DELHI
110062
India |
| Phone |
9560489361 |
| Fax |
|
| Email |
riatyagi98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hamdard Institute of Medical Sciences and Research, Guru Ravidas Marg, Hamdard Nagar, New Delh, India , ND- 110062 |
|
|
Primary Sponsor
|
| Name |
Hamdard Institute of Medical Sciences and Research |
| Address |
Hamdard Institute of Medical Sciences and Research, Guru Ravidaas marg Hamdard Nagar, New Delhi, India ND- 110062 |
| 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 Ria Tyagi |
Operation Rooms,Hamdard Institute of Medical Sciences and Research and HAHC Hospital |
Operation Theatre, 8th Floor, New Hospital Building, B Block, Hamdard Institute of Medical Sciences and Research, Hamdard Nagar, New Delhi
South
DELHI |
09560489361
riatyagi98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Hamdard Institute of Medical Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K80||Cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Neurobion Forte |
Using Neurobion Forte as placebo, it is a vitamin B-complex supplement that contains a combination of B1 (thiamine), B6 (pyridoxine), and B12 (cyanocobalamin). It is commonly used to support nerve health, energy production, and overall well-being |
| Intervention |
Tablet Melatonin |
Melatonin (N-acetyl-5-methoxytryptamine) is an endogenous sleep regulating hormone secreted by pineal gland. Exogenous administration of melatonin facilitates sleep onset and improves the quality of sleep.
The perioperative use of melatonin - in alleviating anxiety, reducing intraoperative anaesthetic requirement, as analgesic for post-operative pain management, to prevent postoperative neurocognitive disorder, have been well-documented by various studies.
Recently, studies have reported the effect of oral melatonin premedication on attenuation of haemodynamic response to intubation in adults as melatonin may interfere with the peripheral and central autonomic system, causing a reduction in adrenergic outflow and catecholamines level. It may also bind to specific melatonin receptors ( MT1 & MT2) in the blood vessels, interfering with the vascular response to catecholamines. Moreover, melatonin is a relatively safe drug with minimal side effects
|
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
This prospective, randomized, double-blind study will be conducted on 70 patients undergoing laparoscopic cholecystectomy under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
1.Patient not consenting
2.Known or anticipated difficult airway
3.Morbid Obesity
4.History of mental illness
5.Known Allergy to the study drug
6.History of GERD
7.Patient on Antipsychotic, Sedatives, Anxiolytics, Antiepileptics
8.Patient having History of Sleep Disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| compare the effect of oral melatonin premedication versus placebo on changes in Systolic Blood Pressure following intubation. |
Baseline in Operation theatre, After induction, before intubation, after intubation, 1 minute post intubation, 3 minute post intubation, 5 minute post intubation, 10 minute post intubation, creation of pneumoperitneum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To compare the effects of oral melatonin premedication on changes in Diastolic Blood Pressure, Mean Arterial Pressure and heart rate following intubation between the groups.
2)To compare the propofol dose required for induction of general anaesthesia
3)To compare the intraoperative requirement of isoflurane and fentanyl
|
Baseline in Operation theatre, After induction, before intubation, after intubation, 1 minute post intubation, 3 minute post intubation, 5 minute post intubation, 10 minute post intubation, creation of pneumoperitneum |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 2 |
|
Date of First Enrollment (India)
|
22/04/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [riatyagi98@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
We aim to evaluate the effects of oral melatonin (6 mg) on hemodynamic responses to intubation and anesthetic requirements in geriatric patients undergoing laparoscopic cholecystectomy.
Background & Rationale: Intubation triggers sympathetic activation, leading to increased heart rate and blood pressure, which can be harmful to elderly patients with cardiovascular conditions. Commonly used drugs (opioids, beta-blockers, benzodiazepines) can cause adverse effects like hypotension, respiratory depression, and bradycardia. Melatonin, a naturally occurring hormone, has sedative, anxiolytic, and hemodynamic stabilizing properties with minimal side effects. The hemodynamic responses are noted at various times.
|