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CTRI Number  CTRI/2025/09/095057 [Registered on: 18/09/2025] Trial Registered Prospectively
Last Modified On: 17/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Oral melatonin and alprazolam for postoperative pain management in abdominal hysterectomy. 
Scientific Title of Study   Comparison of preoperative oral melatonin and alprazolam on postoperative pain management in patients undergoing elective abdominal hysterectomy. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CRJPP7807A  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhirami NP 
Designation  Junior resident , Department of Anaesthesiology 
Affiliation  Government Medical College Kozhikode  
Address  Government Medical College, Kozhikode, Kerala, India, 673008

Kozhikode
KERALA
673008
India 
Phone  9995004511  
Fax    
Email  abhiramisatheesh01@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Binu Sajid 
Designation  Professor, Department of Anaesthesiology 
Affiliation  Government Medical College Kozhikode  
Address  Government Medical College, Kozhikode , Kerala, India, 673008

Kozhikode
KERALA
673008
India 
Phone  09447324632  
Fax    
Email  binusajid@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Abhirami NP 
Designation  Junior resident , Department of Anaesthesiology 
Affiliation  Government Medical College Kozhikode  
Address  Department of Anaesthesiology, Government Medical College, Kozhikode, Kerala, India, 673008

Kozhikode
KERALA
673008
India 
Phone  9995004511  
Fax    
Email  abhiramisatheesh01@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College, Kozhikode, Department of Anaesthesiology, Medical College Campus, Kozhikode, Kerala, India, 673008 
 
Primary Sponsor  
Name  Abhirami NP  
Address  Department of Anaesthesiology, Government Medical College, Medical College Campus, Kozhikode, Kerala, India, 673008 
Type of Sponsor  Other [Self] 
 
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 
Dr Abhirami NP  Government Medical College, Kozhikode  Department of Anaesthesiology, Government Medical College Kozhikode, Medical College Road, Kozhikode 673008,Kerala, India
Kozhikode
KERALA 		 9995004511

abhiramisatheesh01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N950||Postmenopausal bleeding,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Oral Alprazolam 0.25 mg tablet  Oral Alprazolam 0.25 mg tablet given at 10 pm on the night before surgery. 
Intervention  Oral Melatonin 5 mg tablet  Oral Melatonin 5 mg tablet given at 10 pm on the night before surgery and at 6 am on the day of surgery. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Female patients aged more than thirty years but less than sixty five years.
Patients undergoing elective abdominal hysterectomy.
Patients belonging to American Society of Anaesthesiologists physical status class one or two.
Height between one hundred fifty centimeter and one hundred seventy centimeter.
Body mass index between eighteen and thirty kilogram per square meter. 
 
ExclusionCriteria 
Details  Patients with contraindications to regional anaesthesia.
Patients with mental impairment.
Patients with history of chronic pain.
Patients with history of psychiatric illness or those taking psychotropic drugs in the past or present.
Patients posted for emergency surgeries. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Preoperative oral melatonin significantly reduces postoperative pain scores compared to those receiving oral aprazolam as premedication in patients undergoing elective abdominal hysterectomy.   6,12,24 hours  
 
Secondary Outcome  
Outcome  TimePoints 
Preoperative oral melatonin reduces anxiety more compared to preoperative oral alprazolam.  30 minutes before surgery 
Preoperative oral melatonin providesbetter sedation than oral alprazolam.  6,12 hours 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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)   29/09/2025 
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="1"
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   This is a prospective randomized comparative study conducted in the Department of Anesthesiology, Government Medical College, Kozhikode. The study aims to compare the effects of preoperative oral melatonin and alprazolam on postoperative pain management in patients undergoing elective abdominal hysterectomy. Eligible patients will be randomized into two groups and assessed for postoperative pain and analgesic requirements as per the study protocol. 
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