| CTRI Number |
CTRI/2025/11/097233 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare two medicines to improve sleep after surgery in adult patients receiving general anaesthesia |
|
Scientific Title of Study
|
Comparison of the postoperative sleep quality with oral zolpidem versus oral melatonin in adult patients undergoing elective surgery under general anaesthesia: A randomized controlled 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 |
Prakash Aaditya |
| Designation |
Post Graduate Resident |
| Affiliation |
Lady Hardinge Medical College and SSKH |
| Address |
Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Road, Connaught Place, DIZ Area, New Delhi, Delhi, India
110001
Central DELHI 110001 India |
| Phone |
9636048281 |
| Fax |
|
| Email |
pt846003@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Garima Agrawal |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical College and SSKH |
| Address |
Department of Anaesthesia, Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Road, Connaught Place, DIZ Area, New Delhi, Delhi, India
110001
Central DELHI 110001 India |
| Phone |
8826640501 |
| Fax |
|
| Email |
garima2396@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prakash Aaditya |
| Designation |
Post Graduate Resident |
| Affiliation |
Lady Hardinge Medical College and SSKH |
| Address |
Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Road, Connaught Place, DIZ Area, New Delhi, Delhi, India
110001
Central DELHI 110001 India |
| Phone |
9636048281 |
| Fax |
|
| Email |
pt846003@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Road, Connaught Place, DIZ Area, New Delhi, Delhi, India
110001 |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College and SSKH |
| Address |
Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Road, Connaught Place, DIZ Area, New Delhi, Delhi, India
110001 |
| Type of Sponsor |
Government 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 Prakash Aaditya |
Lady Hardinge Medical College and associated hospitals |
Lady Hardinge Medical College, Shaheed Bhagat Singh Road, Connaught Place, DIZ Area, New Delhi, Delhi, India
110001 Central DELHI |
9636048281
pt846003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Human Research, LHMC and associated hospitals, New Delhi, Delhi. 110001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K31||Other diseases of stomach and duodenum, (2) ICD-10 Condition: K35-K38||Diseases of appendix, (3) ICD-10 Condition: K40-K46||Hernia, (4) ICD-10 Condition: K55-K64||Other diseases of intestines, (5) ICD-10 Condition: K65-K68||Diseases of peritoneum and retroperitoneum, (6) ICD-10 Condition: K70-K77||Diseases of liver, (7) ICD-10 Condition: K80||Cholelithiasis, (8) ICD-10 Condition: K81||Cholecystitis, (9) ICD-10 Condition: K85||Acute pancreatitis, (10) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (11) ICD-10 Condition: K90-K95||Other diseases of the digestive system, (12) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
postoperative sleep quality with oral melatonin tablet in adult patients undergoing elective surgery under general
anaesthesia |
Patients will receive Oral Melatonin 5mg tablet, 9 PM night before surgery.The Richards-Campbell Sleep Questionnaire will be administered in the preoperative period in the morning (6AM) of the surgery. Induction of General anaesthesia as per standard protocol. Patients will receive another dose of Melatonin 5mg tablet at 9pm in the night after surgery. Sleep quality will be re-evaluated in the first postoperative night using RCSQ
Duration of intervention is 24 hours. |
| Intervention |
postoperative sleep quality with oral zolpidem tablet in adult patients undergoing elective surgery under general
anaesthesia |
Patients will receive Oral Zolpidem 5mg tablet, 9 PM night before surgery.The Richards-Campbell Sleep Questionnaire will be administered in the preoperative period in the morning (6AM) of the surgery. Induction of General anaesthesia as per standard protocol. Patients will receive another dose of Zolpidem 5mg tablet at 9pm in the night after surgery. Sleep quality will be re-evaluated in the first postoperative night using RCSQ
Duration of intervention is 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA physical status I-II
2. Scheduled for elective laparoscopic abdominal surgery under general anaesthesia of
minimum duration 1 hour and maximum duration 3 hours |
|
| ExclusionCriteria |
| Details |
1. Known history of obstructive sleep apnea (OSA) or use of continuous positive airway
pressure (CPAP)
2. Pre-existing neurological, psychiatric, cognitive impairment or sleep disorders
3. Chronic use of antidepressants, antipsychotics, opioids, sedatives, or steroids or
drug/alcohol abuse
4. Known allergy to zolpidem or melatonin |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean ± standard deviation of Richards-Campbell Sleep Questionnaire to assess subjective postoperative sleep quality in patients receiving oral zolpidem versus melatonin after elective surgery under general anaesthesia. |
6am on Post-operative day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The incidence of intraoperative adverse events, including bradycardia and hypotension, expressed as proportions in each group |
during the surgery |
The median (interquartile range) of Visual Analogue Scale for Anxiety (VASA)
scores to quantify postoperative anxiety levels |
morning of the surgery and morning following first night after surgery |
| The mean ± standard deviation of rescue analgesic consumption |
first 24 hours following surgery |
| Median score (IQR) of polysomnography to assess objective sleep quality. |
morning of the surgery and morning following first night after surgery |
correlation between subjective (RCSQ) and objective (polysomnography)
measures of postoperative sleep quality. |
morning of the surgery and morning following first night 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
|
N/A |
|
Date of First Enrollment (India)
|
22/11/2025 |
| 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="1" Months="1" Days="20" |
|
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
|
Study will be conducted after approval from the institutional ethical committee IEC and will be registered with Clinical Trial Registry India CTRI. A detailed pre anaesthetic checkup, detailed history, physical examination and baseline investigations as per clinical requirements will be performed. A written and informed voluntary consent will be obtained from the patient.
Quality assurance mechanism Recruitment of the subjects, sampling strategy, methods of data collection and subsequent data handling will be predefined. All the procedures to be performed will be standardized and training will be provided to reduce variability in outcome measurement.
Trial monitoring mechanism The rights and well being of subjects will be protected. The reported trial data will be accurate, complete and verifiable from source document. The conduct of the trial will be in compliance with the protocol, good clinical practice and with the applicable regulatory requirements. Trial recruitment and outcome measurement process will be kept uniform throughout the study.
Clinical equipoise Before randomly assigning patients to both the competing groups, investigator involved in both groups will be free of any treatment preferences and the subjects involved will not be devoid of any treatment care if needed.
A thorough pre anaesthetic examination will be performed prior to the procedure. A written informed voluntary consent will be obtained from the patient after carefully explaining the procedure including its benefits and risks in the patients own language. Patients will be kept nil per oral NPO for at least 8 hours for solid foods prior to surgery as per standard guidelines. All patients will be premedicated with tablet pantoprazole 40 mg on the night before surgery.
Randomization A computer generated unique randomization code will be generated and with the help of sealed envelope technique, patients will be randomized into two groups as follows Group A Zolpidem group patients who will receive oral zolpidem 5 mg at 9 PM the night before surgery. Group B Melatonin group patients who will receive oral melatonin 5 mg at 9 PM the night before surgery.
Allocation concealment The results of the allocation will be concealed and delivered in a sealed opaque envelope mentioning the code and the group number in the morning of the surgery.
Blinding The patient and the observer data collector will not know the premedication oral zolpidem or oral melatonin being given to the patient.
Sleep Quality Assessment The Richards Campbell Sleep Questionnaire which is a subjective measure for sleep quality will be administered by an independent observer in the preoperative period in the morning 6 AM of the surgery. At the same time, VAS scoring for assessment of anxiety will be performed using a 10 cm scale in which 0 signifies absence of anxiety and 10 signifies maximum anxiety.
After arrival in the operating room, an 18G or 20G peripheral intravenous IV catheter will be inserted. Standard monitoring will be applied including non invasive blood pressure NIBP, electrocardiograph ECG with heart rate HR, pulse oximetry SpO2 and temperature.
Induction of anesthesia will be performed using injection fentanyl 1 to 2 microgram per kg IV and injection propofol 2 to 2.5 mg per kg IV. Muscle paralysis will be achieved with non depolarizing muscle relaxant injection rocuronium 0.6 mg per kg IV followed by intermittent positive pressure ventilation with oxygen and sevoflurane and endotracheal intubation after 3 minutes.
Anesthesia shall be maintained with oxygen and sevoflurane along with top up doses of injection rocuronium. Intraoperative hemodynamics will be managed according to surgical procedure and blood loss. Trachea shall be extubated as per standard protocol using injection neostigmine 0.05 mg per kg IV and injection glycopyrrolate 0.01 mg per kg IV.
Intraoperative adverse reactions including hypertension, hypotension, bradycardia and tachycardia will be recorded. Postoperative pain management will be provided with injection diclofenac sodium 75 mg every 8 hours and injection paracetamol 1 g every 8 hours to maintain a VAS score of 4 or less. Rescue analgesia shall be provided with injection tramadol 50 mg.
Patients shall receive another dose of tablet melatonin or tablet zolpidem as per the allocated group at 9 PM on the night following surgery POD 0. Sleep quality will be re evaluated in the first postoperative night POD 0 using polysomnography performed from 10 PM to 6 AM and the Richards Campbell Sleep Questionnaire RCSQ and VAS A scoring for assessment of anxiety on the next morning POD 1.
Polysomnographic monitoring will be performed by an independent observer trained to use the PSG machine. Total sleep time TST which is the total amount of time a person actually spends asleep will be noted. It excludes time spent awake and will be calculated as time spent in NREM plus REM. Sleep efficiency SE defined as the percentage of time the person is actually asleep that is time from lights off to first awakening will be recorded. It will be calculated as total sleep time divided by total time in bed multiplied by 100. Arousal index AI which is the number of arousals per hour of sleep will be noted. An arousal will be defined as a brief shift from deeper to lighter stages of sleep or wakefulness lasting at least 3 seconds. It will be calculated as total number of arousals divided by total sleep time in hours. |