| CTRI Number |
CTRI/2021/03/032123 [Registered on: 18/03/2021] Trial Registered Prospectively |
| Last Modified On: |
02/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To assess the effect of different doses of tablet melatonin (used as sedative, anxiolytic, antihypertensive drug) in reducing blood pressure and heart rate response while inserting a tube in trachea for providing general anaesthesia |
|
Scientific Title of Study
|
Effect of different doses of oral melatonin as a premedication for attenuation of intubation response |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Reshma B M |
| Designation |
Assistant Professor |
| Affiliation |
Dr B.R. Ambedkar medical college and hospital |
| Address |
Department of Anaesthesiology, 1st floor, OT complex, Dr B.R. Ambedkar medical hospital, Kadugondanalli,
Bengaluru -560045
Department of Anaesthesiology, 1st floor, OT complex, Dr B.R. Ambedkar medical hospital, Kadugondanalli,
Bengaluru -560045
Bangalore
KARNATAKA
560045
India |
| Phone |
8892019120 |
| Fax |
|
| Email |
lucky3276@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Reshma B M |
| Designation |
Assistant Professor |
| Affiliation |
Dr B.R. Ambedkar medical college and hospital |
| Address |
Department of Anaesthesiology, 1st floor, OT complex, Dr B.R. Ambedkar medical hospital, Kadugondanalli,
Bengaluru -560045
Department of Anaesthesiology, 1st floor , OT complex, Dr B.R. Ambedkar medical hospital, Kadugondanahalli,Bengaluru-560045
Bangalore
KARNATAKA
560045
India |
| Phone |
8892019120 |
| Fax |
|
| Email |
lucky3276@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Reshma B M |
| Designation |
Assistant Professor |
| Affiliation |
Dr B.R. Ambedkar medical college and hospital |
| Address |
Department of Anaesthesiology, 1st floor, OT complex, Dr B.R. Ambedkar medical hospital, Kadugondanalli,
Bengaluru -560045
Department of Anaesthesiology, 1st floor, OT complex, Dr B.R. Ambedkar medical hospital, Kadugondanahalli, Bengaluru -560045
Bangalore
KARNATAKA
560045
India |
| Phone |
8892019120 |
| Fax |
|
| Email |
lucky3276@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr B.R. Ambedkar medical college and hospital, Kadugondanahalli, Bengaluru -560045 |
|
|
Primary Sponsor
|
| Name |
Reshma B M |
| Address |
Department of Anaesthesiology, 1st floor, OT complex, Dr B.R. Ambedkar medical hospital, Kadugondanahalli, Bengaluru-560045 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR M SALIM IQBAL |
PROFESSOR, DEPARTMENT OF ANAESTHESIOLOGY, DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, K G HALLI, BENGALURU -560045 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Reshma B M |
Dr B.R. Ambedkar medical hospital |
1st floor, OT complex, Department of Anaesthesiology, Kadugondanahalli, Bengaluru -560045
Bangalore
KARNATAKA |
8892019120
lucky3276@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION 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 |
| Comparator Agent |
NOT APPLICABLE |
NIL |
| Intervention |
Tablet Melatonin 6 mg, tablet Melatonin 9 mg |
Single dose of either tablet Melatonin 6 mg or tablet Melatonin 9 mg will be given orally 2 hours prior to intubation with sips of water to patients undergoing elective surgeries under general anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing elective surgeries under general anaesthesia
2. Patients belonging to American Society of Anaesthesiologists Physical Status (ASA-PS) 1 and 2 |
|
| ExclusionCriteria |
| Details |
1. Refusal to consent for study
2. Allergy to melatonin
3. Patients receiving treatment with study drug (melatonin)
4. Anticipated difficult intubation [Modified Mallampati class 3 and 4]
5. More than 2 intubation attempts or intubation time more than 15 seconds
6. Patients with uncontrolled hypertension and diabetes.
7. Patients with severe cardiac, renal or hepatic disease.
8. Pregnancy and lactation.
9. Patients on hypnotics, sedatives, anxiolytics, anti-epileptics. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of oral melatonin 6mg compared with 9mg in attenuating
the blood pressure (BP) and heart rate (HR) following laryngoscopy and
intubation.
|
Baseline, every minute for
5 minutes, 10th and 15th minute after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the level of sedation and anxiety scores before induction of
anaesthesia.
2. To assess the side effects like nausea and vomiting in postoperative period
3. To assess hemodynamic response to extubation.
|
1.To assess the level of sedation and anxiety scores before induction of
anaesthesia.
2. To assess the side effects like nausea and vomiting in postoperative period
3. To assess hemodynamic response to extubation.
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/03/2021 |
| Date of Study Completion (India) |
26/11/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
- Melatonin is a endogenous sleep regulating hormone secreted by pineal gland responsible for various physiological functions like circadian rythm, reproductive function, mood and immune function.(1) It has inhibitory action on central nervous system responsible for sedation and anxiolysis thus having role in attenuating haemodynamic response to laryngoscopy and intubation.(2)- In our study, we compare two different doses 6mg and 9mg of oral melatonin, given as a premedication 2 hours before surgery in attenuating the haemodynamic responses to laryngoscopy and intubation.
- We hypothesize, that melatonin 9mg is more effective in attenuating haemodynamic response to laryngoscopy and intubation. |