| CTRI Number |
CTRI/2024/12/078260 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare how well two different dosages of oral melatonin (6mg and 9mg) attenuate rise in blood pressure and heart rate in response to laryngoscopy and intubation when given 1 hour before administration of general anaesthesia. |
|
Scientific Title of Study
|
A study to compare the effects of two different dosages of oral melatonin 1 hour before induction for attenuation of haemodynamic response to endotracheal intubation under general anaesthesia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHAH VIHAR PAURAVBHAI |
| Designation |
Resident Doctor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
2nd Floor, General Ot Complex, Department of Anaesthesia, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Dhiraj General Hospital,Waghodiya, Piparia ,Vadodara,GUJARAT,391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9426651039 |
| Fax |
|
| Email |
viharshah18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Chauhan |
| Designation |
Professor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia ,Vadodara,GUJARAT,391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9099014672 |
| Fax |
|
| Email |
drdinesh77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh Chauhan |
| Designation |
Professor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia ,Vadodara,GUJARAT,391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9099014672 |
| Fax |
|
| Email |
drdinesh77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Wagodhia , Pipariya,
Vadodara, Gujarat , India Pincode- 391760 |
|
|
Primary Sponsor
|
| Name |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Waghodia, Pipariya, Vadodara, Gujarat, India Pincode-391760 |
| 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 Dinesh Chauhan |
Smt Bhikhiben Kanjibhai Shah Medical Institute and Research Centre |
2nd Floor, General OT Complex, Anaesthesia department, Dhiraj Hospital, Smt Bhikhiben Kanjibhai Shah Medical Institute and Research Centre, Sumandeep Vidyapeeth, Waghodia, Pipariya, Vadodara , Gujarat 391760
Vadodara
GUJARAT |
9099014672
dr.dinesh77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidhyapeeth Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H958||Other intraoperative and postprocedural complications and disorders of the ear and mastoid process, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Melatonin |
Drug: Melatonin
Route: Oral
Dose: 6mg
Frequency: Once, 60 minutes before induction. |
| Comparator Agent |
Melatonin |
Drug: Melatonin
Route: Oral
Dose: 9mg
Frequency: Once, 60 minutes before induction. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to sign informed consent.
Patients belonging to American Society of Anaesthesiologists (ASA) physical status I and II.
Patients posted for elective surgeries requiring endotracheal intubation under general anaesthesia.
Patient having mouth opening more than 3cm
Patient with Malampatti grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patients unwilling to participate in the study.
Patients having contraindication to endotracheal intubation/general anaesthesia.
Patient having mouth opening less than 3cm.
Patient with Mallampati grade 3 and 4
body mass index (BMI) more than 30 kg per m square.
patients taking anxiolytics, sedatives, antipsychotic, or antiepileptic drugs.
Patients having a sleep disorder, hiatus hernia, gastroesophageal reflux, known allergy to melatonin, and a known case of coronary artery disease.
Patients with ischemic and valvular heart disease. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study attenuation in stress repsonse and haemodynamics and
during intubation and laryngoscopy |
Baseline
60 mins after drug administration
Just after induction
Just after laryngoscopy and intubation
At 1 minute
At 3 minutes
At 5 minutes
At 10 minutes
At 15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study post op sedation score after extubation or any side effects upto 120 minutes. |
Ramsey sedation scale(RSS) will be used to assess post op sedation score at 15, 30, 60, 90 and 120 minutes after extubation. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/12/2024 |
| 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="0"
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-identification.
- 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 - 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 (Others) - dr.dinesh77@gmail.com
- For how long will this data be available start date provided 20-11-2025 and end date provided 20-11-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NO
|
|
Brief Summary
|
THE PURPOSE OF THIS STUDY IS TO COMPARE THE EFFECTS OF TWO DIFFERENT DOSAGES OF ORALLY ADMINISTERED MELATONIN 60 MINUTES BEFORE INDUCTION FOR MONITORING ATTENUATION OF HAEMODYNAMIC RESPONSE TO ENDOTRACHEAL INTUBATION AND ALSO TO ASSESS POST OPERATIVE SEDATION SCORE 120 MINS AFTER EXTUBATION IN PATIENTS UNDER GOING ELECTIVE OPERATIVE INTERVENTIONS UNDER GENERAL ANAESTHESIA. |