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CTRI Number  CTRI/2021/09/036209 [Registered on: 03/09/2021] Trial Registered Prospectively
Last Modified On: 07/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of the effect of melatonin(sleep-wake regulating hormone) premedication on preoperative anxiety, propofol(general anaesthetic) induction dosage, perioperative haemodynamics(blood pressure,heart rate) and quality of recovery : An exploratory study  
Scientific Title of Study   Evaluation of the effect of melatonin premedication on preoperative anxiety, propofol induction dosage, perioperative haemodynamics and quality of recovery : An exploratory study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manasmita Dalai 
Designation  Junior resident 
Affiliation  AIIMS Rishikesh 
Address  Department of Anaesthesiology, level-6, Hospital building, All India Institute of Medical Science, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9438811991  
Fax    
Email  manasmita.bini@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sanjay Agrawal 
Designation  Professor and HOD Department of Anaesthesiology 
Affiliation  AIIMS Rishikesh 
Address  Department of Anaesthesiology, level-6, Hospital building, All India Institute of Medical Science, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9761712630  
Fax    
Email  docagrawal72@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Manasmita Dalai 
Designation  Junior resident 
Affiliation  AIIMS Rishikesh 
Address  Department of Anaesthesiology, level-6, Hospital building, All India Institute of Medical Science, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9438811991  
Fax    
Email  manasmita.bini@gmail.com  
 
Source of Monetary or Material Support  
Aiims Rishikesh 
 
Primary Sponsor  
Name  Manasmita Dalai 
Address  Junior resident, Department of Anaesthesiology, level-6, Hospital building, All India Institute of Medical Science, Rishikesh, district-Dehradun, Uttarakhand,PIN-249203 
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 
Manasmita Dalai  All India Institute of Medical Science, Rishikesh  OT complex, Department of Anaesthesiology, level-6, Hospital building
Dehradun
UTTARANCHAL 		 9438811991

manasmita.bini@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Rishikesh Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N709||Salpingitis and oophoritis, unspecified, (2) ICD-10 Condition: N72||Inflammatory disease of cervix uteri, (3) ICD-10 Condition: N719||Inflammatory disease of uterus, unspecified, (4) ICD-10 Condition: N739||Female pelvic inflammatory disease, unspecified, (5) ICD-10 Condition: N74||Female pelvic inflammatory disorders in diseases classified elsewhere, (6) ICD-10 Condition: N809||Endometriosis, unspecified, (7) ICD-10 Condition: N819||Female genital prolapse, unspecified, (8) ICD-10 Condition: N839||Noninflammatory disorder of ovary,fallopian tube and broad ligament, unspecified, (9) ICD-10 Condition: N849||Polyp of female genital tract, unspecified, (10) ICD-10 Condition: N889||Noninflammatory disorder of cervixuteri, unspecified, (11) ICD-10 Condition: N879||Dysplasia of cervix uteri, unspecified, (12) ICD-10 Condition: N926||Irregular menstruation, unspecified, (13) ICD-10 Condition: N979||Female infertility, unspecified, (14) ICD-10 Condition: N839||Noninflammatory disorder of ovary,fallopian tube and broad ligament, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Tablet Alprazolam 0.25mg  Group 2: Tab Alprazolam 0.25 mg night before surgery and 2 hour before surgery with sips of water 
Intervention  Tablet Melatonin 5 mg  Group1: Tab Melatonin 5mg night before surgery and 2 hour before surgery with sips of water  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1. ASA-I, I

2. Female Patient

3. 18 to 65 years of age undergoing elective laparoscopic gynaecological surgery



 
 
ExclusionCriteria 
Details 
1. patient not willing to participate

2. significant cardiac, hepatic renal dysfunction

3. allergy to study drugs

4. Patient with a history of chronic use of sedatives or analgesics especially

opioids and gabapentinoids

5. patients requiring post operative ventilatory support 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Preoperative anxiety and sedation
2.Quality of recovery (QoR 15 score)

 		 From time in preoperative room till 24hour of surgery
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Induction dosage of propofol

2.Perioperative haemodynamic effects 		 From start of induction till 24 hour after surgery 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 3/ Phase 4 
Date of First Enrollment (India)   10/09/2021 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Proposal should be directed to the corresponding author via email: docagrawal72@yahoo.com . To gain access , data requesters will need to sign a data access aggreement and to confirm that data will only be used for the agreed purpose for which access was granted

  6. For how long will this data be available start date provided 01-06-2023 and end date provided 07-08-2021?
    Response (Others) -  Beginning 1 month after article publication with no end date

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Melatonin is expected to decrease preoperative anxiety and improve quality of recovery 15 score compared to alprazolam 
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