| CTRI Number |
CTRI/2025/07/091710 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study of Effects of Oral Melatonin with Oral Alprazolam Used as Premedication in Adult Patients Undergoing Surgery Under General Anaesthesia |
|
Scientific Title of Study
|
A Randomized Single Blinded Study Comparing the Effects Of Oral Melatonin with Oral Alprazolam used as Premedication in Adult Patients Undergoing Surgery 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 |
Dr Avinash K |
| Designation |
Associate Professor |
| Affiliation |
KLE Jagadguru Gangadhar Mahaswamigalu Moorsavirmath Medical College |
| Address |
Department of Anaesthesiology,KLE Hubli Cooperative Hospital, KLE Jagadguru Gangadhar Mahaswamigalu Moorsavirmath Medical College, Hubli
Dharwad
KARNATAKA
580020
India |
| Phone |
7349040864 |
| Fax |
|
| Email |
avidoc81@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avinash K |
| Designation |
Associate Professor |
| Affiliation |
KLE Jagadguru Gangadhar Mahaswamigalu Moorsavirmath Medical College |
| Address |
Department of Anaesthesiology,KLE Hubli Cooperative Hospital, KLE Jagadguru Gangadhar Mahaswamigalu Moorsavirmath Medical College, Hubli
Dharwad
KARNATAKA
580020
India |
| Phone |
7349040864 |
| Fax |
|
| Email |
avidoc81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Avinash K |
| Designation |
Associate Professor |
| Affiliation |
KLE Jagadguru Gangadhar Mahaswamigalu Moorsavirmath Medical College |
| Address |
Department of Anaesthesiology,KLE Hubli Cooperative Hospital, KLE Jagadguru Gangadhar Mahaswamigalu Moorsavirmath Medical College, Hubli
Dharwad
KARNATAKA
580020
India |
| Phone |
7349040864 |
| Fax |
|
| Email |
avidoc81@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Hubli Cooperative Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Avinash K |
| Address |
Department Of Anaesthesiology, KLE Jagadguru Gangadhar Mahaswamigalu Moorsavirmath Medical College,Hubli,Karnataka,India-580028 |
| 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 Avinash K |
KLE Hubli Cooperative Hospital |
Department Of Anaesthesiology,KLE Hubli Cooperative Hospital,KLE Jagadguru Gangadhar Mahaswamigalu Moorsavirmath Medical College, Coen Road, Hubli-580020
Dharwad
KARNATAKA |
7349040864
avidoc81@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JGMM Medical College Institution Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Preoperative oral Alprazolam |
Patient given medication 120 min before surgery |
| Intervention |
Preoperative oral Melatonin |
Patient given medication 120 min before surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society Of Anaesthesiologists Grade I-II
2. Posted for Surgery greater than One Hour Under General Anaesthesia.
3. Patients giving Valid and Informed Consent |
|
| ExclusionCriteria |
| Details |
1.Patients with ASA physical status classes 3 and above.
2.Age greater than 60 years or less than 18 years.
3.Patients having allergy to any of the study drugs
4.Pregnant women
5.Patients with any mental illness.
6.Patients on steroids and antipsychotics.
7.Patients unable to read or write basic alphabets.
8.Patients with uncontrolled hypertension and diabetes
9.Patient refusal.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare effect of premedication with melatonin and alprazolam on preoperative anxiety,sedation,orientation and cognitive function. |
0min and 120 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/09/2025 |
| 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="0"
Months="4"
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
|
Preoperative Anxiety is a common thing among patients posted for surgery. To allay the fears of the patient prior to surgery ,premedication is given to the patient. In our study we are comparing the effects of one commonly used drug for premedication like Alprazolam and the other drug melatonin. The effects of Melatonin as premedication drug is not fully understood , Hence this study |