| CTRI Number |
CTRI/2025/07/090884 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Compare oral clonidine and oral melatonin as premedication to check responses during laryngoscopy and intubation |
|
Scientific Title of Study
|
Study to compare oral clonidine versus oral melatonin premedication on hemodynamic responce to laryngoscopy and intubation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul Acharya |
| Designation |
PG student |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
2nd Floor OT Complex Department of Anaesthesia at Mahatma Gandhi Medical College and Hospital Sitapura Jaipur Department of Anaesthesia Mahatma Gandhi Medical College and hospital
Jaipur
RAJASTHAN
302022
India |
| Phone |
9427902281 |
| Fax |
|
| Email |
rahulacharya7900@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Khayyam Moin |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
2nd Floor OT Complex Department of Anaesthesia at Mahatma Gandhi Medical College and Hospital Sitapura Jaipur Department of Anaesthesia Mahatma Gandhi Medical College and hospital
Jaipur
RAJASTHAN
302022
India |
| Phone |
9468964148 |
| Fax |
|
| Email |
khayyammoin@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Khayyam Moin |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
2nd Floor OT Complex Department of Anaesthesia at Mahatma Gandhi Medical College and Hospital Sitapura Jaipur Department of Anaesthesia Mahatma Gandhi Medical College and hospital
Jaipur
RAJASTHAN
302022
India |
| Phone |
9468964148 |
| Fax |
|
| Email |
khayyammoin@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Hospital Jaipur |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Hospital |
| Address |
2nd Floor OT Complex Department of Anaesthesia at Mahatma Gandhi Medical College and Hospital Sitapura Jaipur Department of Anaesthesia Mahatma Gandhi Medical College and hospital |
| 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 Rahul Acharya |
Mahatma Gandhi Medical College and Hospital |
2nd Floor OT Complex Department of Anaesthesia at Mahatma Gandhi Medical College and Hospital Sitapura Jaipur Department of Anaesthesia Mahatma Gandhi Medical College and hospital
Jaipur
RAJASTHAN |
9427902281
rahulacharya7900@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECMGMCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
American Society of anesthesiologists (ASA) 1 or 2 |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral Clonidine |
Oral Clonidine 0.1 mg given 90 min prior to surgery dissolved in 10 millilitres water To attenuate hemodynamic responses (heart rate and blood pressure changes) during laryngoscopy and intubation. |
| Comparator Agent |
Oral Melatonin |
Oral Melatonin 6mg given 90 min prior surgery dissolved in 10 milliliters water to attenuate hemodynamic responses (heart rate and blood pressure changes) during laryngoscopy and intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient posted for elective surgery under General anesthesia
Patient aged between 18-65 years
Patient with American Society of anesthesiologists (ASA) Class I, II
Consented Patients |
|
| ExclusionCriteria |
| Details |
Anticipated difficult intubation
Pregnant and lactating females
Patient receiving treatment with either of the study drug or having known case of allergy to either drugs or any drugs
Patients with prolonged laryngoscopy time(more than 30 seconds)
Body Mass Index (BMI) more than 30 kg/m2
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare different effect of oral melatonin versus oral clonidine as premedication and its response changes in blood pressure , heart rate, and other relevant haemodynamic parameters during direct laryngoscopy and tracheal intubation during induction of general anesthesia in elective surgery |
Baseline vitals followed by vitals at 5,10,15,30,60,90 minutes pre induction vitals followed by vitals at laryngoscopy followed by vitals at 5,10,15,30 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate any differences in side effects or adverse effects between two study groups |
Baseline vitals and sedation score followed by vitals and sedation score at 5,10,15,30,60,90 minutes pre induction vitals followed by vitals at 5,10,15,30 minutes and postoperative vitals and sedationscoreat5,10,15,30,60 minutes. |
|
|
Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
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 1 |
|
Date of First Enrollment (India)
|
25/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/07/2025 |
| 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)
|
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 - NO
|
|
Brief Summary
|
Direct laryngoscopy and endotracheal intubation during general anesthesia acts as a powerful noxious stimulus which causes stimulation of sympathetic nervous system. This leads to various responses in various physiological systems of the body such as tachycardia, hypertension, arrythmia, bronchospasm, increased intracranial pressure, elevation in intraocular pressure. Melatonin is a natural substance produced mainly in the pineal gland Its secretion is high during night and low during day.premedication with sublingual/oral Melatonin is associated with pre-operative anxiolysis and sedation without impairment of orientation, psychomotor skills, or impact on quality of recovery. Clonidine parasympathetic activity by acting on alpha receptor present over tractus solitarius Major site of action for this sedative/hypnotic. Clonidine has various properties like sedation, anxiolysis, antisialogogue, potentiates the anesthetic action of the drugs and reduces their requirements during surgery and attenuation of stress response to noxious stimuli on tracheal intubation.
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