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CTRI Number  CTRI/2025/07/091965 [Registered on: 29/07/2025] Trial Registered Prospectively
Last Modified On: 28/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Comparative study of effectiveness of two different drugs (alprazolam and melatonin) on the quality of sleep in patients posted for elective surgery  
Scientific Title of Study   A Comparative study of effects of melatonin and alprazolam on the quality of sleep in patients posted for elective surgery - prospective randomised control study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Janet Jassica J 
Designation  Post graduate 
Affiliation  St. Johns Medical College and Hospital 
Address  Department of Anaesthesiology,Second Floor OT Complex, St. Johns Medical College and Hospital, Bangalore-560034 Sarjapur - Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  8220432477  
Fax    
Email  janetjassica1998@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vikram Shivappagoudar M 
Designation  Professor 
Affiliation  St. Johns Medical College and Hospital 
Address  Department of Anaesthesiology,Second Floor OT Complex, St. Johns Medical College and Hospital, Bangalore-560034 Sarjapur - Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  9731981665  
Fax    
Email  msvikram681@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vikram Shivappagoudar M 
Designation  Professor 
Affiliation  St. Johns Medical College and Hospital 
Address  Department of Anaesthesiology,Second Floor OT Complex, St. Johns Medical College and Hospital, Bangalore-560034 Sarjapur - Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  9731981665  
Fax    
Email  msvikram681@gmail.com  
 
Source of Monetary or Material Support  
St Johns medical college and hospital, Koramangala, Bangalore-560034 
 
Primary Sponsor  
Name  Dr Janet Jassica J 
Address  Department of Anaesthesiology ,Second Floor OT Complex,St. Johns Medical College and Hospital, Bangalore-560034 
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 
Janet Jassica J  St Johns medical college and hospital  Department Of Anaesthesiology, Second floor OT Complex, St Johns medical college and hospital.Koramangala, Bangalore KARNATAKA
Bangalore
KARNATAKA 
8220432477

janetjassica1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe,St Johns Medical College Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Medication   Medication will be given once at night per orally on the previous day of surgery 
Comparator Agent  Tablet Alprazolam 0.25 mg  Patients in group A will receive Tablet Alprazolam 0.25 mg orally once at 10pm night before their elective surgery. 
Comparator Agent  Tablet Melatonin 3mg  Patients in group M will receive Tablet Melatonin 3mg at 10pm night once before their elective surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  American Society of Anesthesiologists (ASA) physical status Classes 1 and 2, posted for various elective surgeries. 
 
ExclusionCriteria 
Details  Patients with OSA
Patients with h/o insomnia and on insomnia medication
Pregnant women
Patients with any mental illness
Patients on steroids and antipsychotics
Trauma patients
 
 
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 
a) sleep onset
b) sleep duration
c) sleep quality

 
a) baseline before giving medication on the night before surgery and on the morning prior to surgery.
b) baseline before giving medication on the night before surgery and on the morning prior to surgery.
c) baseline before giving medication on the night before surgery and on the morning prior to surgery.
 
 
Secondary Outcome  
Outcome  TimePoints 
pre operative anxiety  baseline before giving medication on the night before surgery & on the morning prior to surgery.
 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   15/08/2025 
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  

Introduction 

Pre-operative sleep disturbances can affect healthy patients who otherwise do not have chronic sleep issues or medical conditions. These disturbances can be triggered by the stress and anxiety associated with the anticipation of surgery, fear of anaesthesia and concerns of the outcome of surgery, leading to difficulty falling asleep or staying asleep. The unfamiliar hospital environment, if patients are required to stay overnight, can worsen sleep disturbances. Alprazolam, a benzodiazepine that acts by enhancing the effects of gamma aminobutyric acid  is used as a pre anaesthetic medication, primarily due to its anxiolytic and sedative properties. A common dose for preoperative anxiety is 0.25 mg to 0.5 mg of alprazolam on the night before surgery. The dose depends on the patient age, medical history, and the level of anxiety. Melatonin is a hormone that plays a key role in regulating the sleep wake cycle. It is naturally produced by the pineal gland in the brain in response to darkness, promoting sleepiness and helping to regulate circadian rhythms. Beyond sleep regulation, melatonin has mild anxiolytic effects, which can help alleviate pre operative anxiety. The typical dose of melatonin for preanesthesia medication ranges from 0.5 mg to 3 mg. Unlike benzodiazepines like midazolam or alprazolam, melatonin does not carry the same risks of dependency or withdrawal, making it a safer option.

 

Primary objective

 To compare the effects of melatonin and alprazolam on the quality of sleep in patients posted for elective surgery

 

Secondary objective

 To assess the pre operative anxiety in both the groups 

State inclusion criteria

Patients aged 18 to 59 years with the American Society of Anaesthesiologists physical status Classes 1 and 2, posted for various elective surgeries.



State exclusion criteria



Patients with OSA

Patients with history of insomnia and on insomnia medication 

Pregnant women

Patients with any mental illness

Patients on steroids and antipsychotics

Trauma patients

 Following written informed consent, they will be randomised into one of the two groups, Alprazolam group A and Melatonin group M. Randomisation will be done by the lot system. A baseline assessment of quality of sleep and anxiety will be done on all patients using the GSQS and STAI 6.

Patients in group A will receive Tablet Alprazolam 0.25 mg orally and and patients of group M will receive Tablet Melatonin 3mg at 10pm night before their elective surgery.

Patients will be instructed to refrain from the caffeinated drinks, screen time and follow their routine sleep schedule.

On the morning of the surgery, the quality of sleep in the night before, will be assessed by the Groningen Sleep Quality Scale GSQS and the anxiety levels will be assessed by the State Trait Anxiety Inventory 6 STAI 6 scale. 

Patients with a GSQS score of 0 to 2 will be considered to have had a good quality sleep, 3 to 5 as with mild sleep disturbances, 6 to 9 as moderate sleep disturbances and 10 to 15 as severe sleep disturbances.

Patients STAI 6 Anxiety score, after reversing the positively worded items, summing the scores, and standardization to 20 to 80 score, patient with score 20 to 39 will be considered as Low anxiety, 40 to 59 as Moderate anxiety and 60 to 80 as High anxiety

 


 
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