| CTRI Number |
CTRI/2025/03/082817 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effects of Melatonin and Alprazolam as pre-medication for anaesthesia |
|
Scientific Title of Study
|
To compare the effects of oral melatonin with oral alprazolam when used as premedication in adult patients undergoing general anaesthesia or spinal 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 Melchisedec SIngh |
| Designation |
Professor |
| Affiliation |
Christian Medical College and Hospital |
| Address |
Department of Anaesthesia,
Christian Medical College and Hospital,
Brown Road, Ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
9876620747 |
| Fax |
|
| Email |
msedec@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Harsha Ruth Peter |
| Designation |
PG Resident |
| Affiliation |
Christian Medical College and Hospital |
| Address |
Department of Anaesthesia,
Christian Medical College and Hospital,
Brown Road, Ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
9787690050 |
| Fax |
|
| Email |
harshapeter85381@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harsha Ruth Peter |
| Designation |
PG Resident |
| Affiliation |
Christian Medical College and Hospital |
| Address |
Department of Anaesthesia,
Christian Medical College and Hospital,
Brown Road, Ludhiana
PUNJAB
141008
India |
| Phone |
9787690050 |
| Fax |
|
| Email |
harshapeter85381@gmail.com |
|
|
Source of Monetary or Material Support
|
| Christian Medical College and Hospital and Hospital, Brown Road, Ludhiana, Punjab. Pin 141008 |
|
|
Primary Sponsor
|
| Name |
Christian Medical College and Hospital Brown Road Ludhiana Punjab Pin |
| Address |
Department of Anaesthesia,
Christian Medical College and Hospital,
Brown Road, Ludhiana |
| 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 Melchisedec Singh |
Christian Medical College and Hospital |
Department of Anaesthesia,
Christian Medical College and Hospital,
Brown Road, Ludhiana
Ludhiana
PUNJAB |
9876620747
msedec@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Christian Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
To compare the effects of oral melatonin with oral alprazolam when used as premedication in adult patients undergoing various surgical procedures under general anaesthesia or spinal anaesthesia. |
Group A will receive Tab. Alprazolam 0.5mg one hour prior to shifting to theatre. |
| Intervention |
To compare the effects of oral melatonin with oral alprazolam when used as premedication in adult patients undergoing various surgical procedures under general anaesthesia or spinal anaesthesia. |
Group B will receive Tab. Melatonin 5mg po one hour prior to shifting to theatre. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All consenting adults who are:
1. Aged between 18-60 years.
2. ASA I and II patients planned for elective surgeries under general anaesthesia or spinal anaesthesia anticipated to last more than one hour.
3. Patients admitted into the hospital at least a day prior to the planned procedure.
|
|
| ExclusionCriteria |
| Details |
1. Age below 18 years or above 60 years
2. All emergency cases.
3. History of allergy to either of the study drugs i.e. Tab. Alprazolam and Tab. Melatonin.
4. History of drug addiction.
5. Patients with psychiatric disorders on medication with benzodiazepenes.
6. Patients who are chronic alcoholics or who have consumed alcohol in the 24 hours prior to planned procedure.
7. Patients with a BMI of more than 30.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess pre operative anxiety |
At the time of pre-a aesthetic check up
One hour prior to shifting to ot |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check for adverse effects of Tab. Alprazolam and Tab. Melatonin |
1. During pre anesthetic check up
2. one hour prior to shifting to theatre |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
25/04/2025 |
| 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="1"
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 - NO
|
|
Brief Summary
|
Background: Preoperative anxiety is a major concern in patients undergoing any surgical procedure. Various drugs have been used to alleviate it. Benzodiazepines are among the most popular preoperative medications because they produce anxiolysis, amnesia and sedation. Melatonin is an endogenous neurohormone secreted by the pineal gland with the unique property of producing anxiolysis with no impairment of cognitive and psychomotor function. However there have been few studies comparing oral alprazolam and oral melatonin. Aims and Objectives: To compare the effects of oral melatonin with oral alprazolam on preoperative anxiety, sedation, and orientation when given as premedication. To study the side effects of alprazolam and melatonin, if any. Materials and Methods: This prospective, randomized controlled study will be conducted on 80 patients, 40 in each group undergoing elective surgeries under general anaesthesia or spinal anaesthesia. Group A will be for patients receiving Tablet Alprazolam and Group B will be for patients receiving Tablet Melatonin. On Day 0, i.e. the day of the pre-anaesthetic checkup, the patients’ haemodynamic parameters as well as Visual Analogue Scale for anxiety (VAS-A) score, Ramsay sedation score (RSS) and Orientation Score will be assessed. On Day 1, i.e. the day of surgery, after the administration of drug one hour prior to the surgery, the same parameters will be assessed inside the operation theatre before starting anaesthesia. |