| CTRI Number |
CTRI/2026/02/103734 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
10/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of melatonin before surgery helps to reduce anxiety and keep vitals stable |
|
Scientific Title of Study
|
Effect of preoperative oral melatonin on perioperative anxiety and hemodynamic response to intubation: A double-blind randomized controlled trial in patients undergoing surgery under general anesthesia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Supriya |
| Designation |
Postgraduate student |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Major OT Complex,room no.48,Anaesthesia department, 3rd floor, MPB Building, Victoria hospital,
Fort Krishna Rajendra Road, Bengaluru
Major OT complex,room no. 48,Anaesthesia department,3rd floor,MPB building Victoria hospital,Fort Krishna Rajendra road,Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
9480588135 |
| Fax |
|
| Email |
Supriyasiri1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Madhu KP |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Major OT Complex,room no.48,Anaesthesia department,3rd floor, MPB Building, Victoria hospital,
Fort Krishna Rajendra Road, Bengaluru
Major OT Complex,room no.48,Anaesthesia department,3rd floor,MPB Building,Victoria Hospital,Fort Krishna Rajendra road ,Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
9380455534 |
| Fax |
|
| Email |
drmadhukp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swathi N |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Major OT Complex,room no.48,Anaesthesia department, 3rd floor, MPB Building, Victoria hospital,
Fort Krishna Rajendra Road, Bengaluru
Mor OT Complex,room no.48,Anaesthesia department,3rd floor,MPB Building,Victoria Hospital,Fort Krishna Rajendra road,Bengaluru
Bangalore
KARNATAKA
560056
India |
| Phone |
9972454989 |
| Fax |
|
| Email |
swathisaggi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical College and Research Institute |
|
|
Primary Sponsor
|
| Name |
Supriya |
| Address |
Bangalore medical college and research institute
Fort Krishna Rajendra Rd Bengaluru-560002 |
| 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 |
| Dr Swathi N |
Bangalore medical college and research institute |
Major OT complex, 3rd floor, Depart of Anaesthesia, MPB Building, Victoria hospital, Bangalore-560002
Bangalore
KARNATAKA |
09972454989
swathisaggi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore Medical College and Research Ethics committee |
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 |
Tablet Melatonin 6 mg |
Tablet given 60 minutes before general anaesthesia induction |
| Comparator Agent |
Tablet Multivitamin |
Tablet given 60 minutes before general anaesthesia induction |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are willing to give written consent
ASA 1/2 patients who will undergo surgical procedures under general anaesthesia
No use of anxiolytic narcotic 24 hours before surgery
Non pregnant females |
|
| ExclusionCriteria |
| Details |
Patient with reduced level of consciousness
Known history of allergy to drugs
Advanced hepatic renal and respiratory diseases
Patients with anticipated difficult Airway
Patients with uncontrolled hypertension and diabetes mellitus |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hamilton anxiety score |
Pre-operative and post-operative at 2 hours and 6 hours post-op |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodymanics, VAS score, Ramsay sedation score, side effects |
Preoperative, intra-operative & post-operatively at 2 hours & 6 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
21/02/2026 |
| 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="4"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [swathisaggi@gmail.com].
- For how long will this data be available start date provided 23-07-2025 and end date provided 24-09-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Laryngoscopy and endotracheal intubation are potent noxious stimuli that can elicit significant sympathetic responses, resulting in undesirable cardiovascular, respiratory, and physiological alterations. These perioperative stress responses are further compounded by preoperative anxiety, which is known to adversely affect patient outcomes. The selection of appropriate premedication and anesthetic strategies plays a critical role in mitigating these effects.
Melatonin, a naturally occurring hormone, has demonstrated anxiolytic, sedative, and analgesic properties, with the added advantage of minimal impact on hemodynamic stability. Given its favorable pharmacological profile, melatonin may serve as an effective premedicant for attenuating anxiety and blunting the hemodynamic response to laryngoscopy and intubation.
Therefore, this study aims to evaluate the efficacy of preoperative oral melatonin in reducing perioperative anxiety and suppressing hemodynamic responses during laryngoscopy and intubation in patients undergoing surgery under general anesthesia.
|