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CTRI Number  CTRI/2025/11/096795 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 02/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   A clinical study comparing the effect of oral melatonin and oral alprazolam as premedication in patients undergoing surgery under general Aneasthesia. 
Scientific Title of Study   A Comparative study between oral melatonin and oral alprazolam as premedicants in patients undergoing surgeries under general anaesthesia: A Clinical Trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kunzang lepcha 
Designation  Post Graduate trainee 
Affiliation  Regional Institute of medical sciences Imphal 
Address  Department of Anaesthesiology Regional Institute of medical sciences Imphal Imphal West MANIPUR 795004 INDIA
Department of Anaesthesiology Regional Institute of medical sciences Imphal Imphal West MANIPUR 795004 INDIA
Imphal West
MANIPUR
795004
India 
Phone  7908712966  
Fax    
Email  kunzanglepcha08@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anita N Devi 
Designation  Professor  
Affiliation  Regional institute of medical sciences imphal 
Address  Department of Anaesthesiology Regional Institute of medical sciences Imphal Imphal West MANIPUR 795004 INDIA
Department of Anaesthesiology Regional Institute of medical sciences Imphal Imphal West MANIPUR 795004 INDIA
Imphal West
MANIPUR
795004
India 
Phone  8787458045  
Fax    
Email  dranitadevin@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anita N Devi 
Designation  Professor  
Affiliation  Regional institute of medical sciences Imphal 
Address  Department of Anaesthesiology Regional Institute of medical sciences Imphal Imphal West MANIPUR 795004 INDIA
Department of Anaesthesiology Regional Institute of medical sciences Imphal Imphal West MANIPUR 795004 INDIA
Imphal West
MANIPUR
795004
India 
Phone  8787458045  
Fax    
Email  dranitadevin@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Regional institute of medical sciences 
Address  Department of Anaesthesiology Regional Institute of medical sciences Imphal Imphal West MANIPUR 795004 INDIA  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Kunzang lepcha  Regional institute of medical sciences  Elective surgery operation theatre Department of Anaesthesiology Regional Institute of medical sciences Imphal Imphal West MANIPUR 795004 INDIA
Imphal West
MANIPUR 
7908712966

Kunzanglepcha08@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Board Regional Institute of Medical Sciences Imphal Manipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Oral alprazolam   Participants in this group will receive oral alprazolam 0.25 mg tablet with a sip of water 60 minutes before induction of general anaesthesia. This serves as the comparator arm to assess and compare its efficacy and safety against oral melatonin in reducing preoperative anxiety, sedation level, and psychomotor performance. 
Intervention  Oral melatonin   Participants in this group will receive oral melatonin 3 mg tablet administered with a sip of water 60 minutes before induction of general anaesthesia. The purpose is to evaluate its effectiveness as a premedicant in reducing preoperative anxiety, inducing sedation, and maintaining cognitive and psychomotor function postoperatively.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of either sex with ASA physical grade 1 and 2 of age group 18 to 60years
 
 
ExclusionCriteria 
Details  Patient with Allergy to study drugs
Pregnant women
Patient with mental illness
Patient on steroids and antipsychotic drugs
Patient unable to read or write
 
 
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 see the reduction in perioperative anxiety with the use of melatonin vs alprazolam in patient undergoing elective surgery under general anaesthesia.  The study drug will be given 120 minutes before the patient is taken inside the operation theatre at the pre anaesthetic check up room.
1st assessment will be done 120 minutes before the drug is given and 2nd assessment will be done 120 minutes after the drug has been given. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the hemodynamic parameters and evaluate the effects of melatonin and alprazolam on sedation cognition psychomotor function and patients satisfaction in the perioperative period.  60 minutes after administration of premedication and before induction of Aneasthesia. 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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 4 
Date of First Enrollment (India)   20/11/2025 
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="2"
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  
Preoperative anxiety is a prevalent issue among patients awaiting elective surgery often driven by
fear of the procedure, anesthesia or hospitalisation. This psychological state can trigger
sympathetic nervous system responses such as elevated heart rate, blood pressure, and perspiration,
which may complicate anesthesia management by increasing anaesthetic requirements and causing
hemodynamic instability. Traditionally, benzodiazepines like alprazolam have been widely used
for their anxiolytic and sedative properties. Alprazolam, a triazolebenzodiazepine, is considered
more anxioselective than others in its class; however, it is associated with drawbacks like cognitive
impairment, restlessness, and dependency risk. In contrast, melatonin a hormone naturally
secreted by the pineal gland has shown promise as a safer alternative. Melatonin induces sedation
and anxiolysis without impairing cognitive or psychomotor function and is known for its
antioxidant, anti-inflammatory, and chronobiotic effects. The current study aims to compare the
effectiveness of oral melatonin (6 mg) and oral alprazolam (0.5 mg) in reducing preoperative
anxiety and to assess their impact on sedation, orientation, cognitive function, and patient
satisfaction. This randomized, double-blind clinical trial will be conducted in the Department of
Anaesthesiology at RIMS, Imphal, enrolling 96 adult patients aged 18-60 years, categorised as
ASA grade I or I. Participants will be randomly assigned to one of two groups-melatonin or
alprazolam,-and administered their respective medications 120 minutes before anesthesia.
Preoperative anxiety, sedation, and cognitive functions will be assessed using validated tools like
the Visual Analogue Scale, Ramsay Sedation Score, Orientation Score, and Digit Symbol
Substitution Test. Standardised anesthesia will be provided across all groups. Data will be
statistically analyzed using SPSS, with significance set at p less than 0.05. This study seeks to address the
limited data comparing these two agents and aims to provide evidence based guidance on the use
of melatonin as a potential alternative to benzodiazepines in preoperative care.
 
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