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CTRI Number  CTRI/2025/03/082307 [Registered on: 13/03/2025] Trial Registered Prospectively
Last Modified On: 01/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Oral Melatonin vs Midazolam for Emergence Delirium in Pediatric Anesthesia: A Randomized Study 
Scientific Title of Study   A prospective randomized study to know the effect of premedication with oral melatonin vs oral midazolam on emergence delirium in children undergoing general anesthesia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Priyanka Dev 
Designation  Associate Professor, Department of Anaesthesia 
Affiliation  North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS) 
Address  Room no 105, Dept. of Anaesthesiology, OPD building NEIGRIHMS Hospital, Mawdiangdiang, Shillong

East Khasi Hills
MEGHALAYA
793018
India 
Phone  7577055859  
Fax    
Email  priyanka8ap@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priyanka Dev 
Designation  Associate Professor, Department of Anaesthesia 
Affiliation  North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS) 
Address  Room no 105, Dept. of Anaesthesiology, OPD building NEIGRIHMS Hospital, Mawdiangdiang, Shillong

East Khasi Hills
MEGHALAYA
793018
India 
Phone  7577055859  
Fax    
Email  priyanka8ap@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Priyanka Dev 
Designation  Associate Professor, Department of Anaesthesia 
Affiliation  North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS) 
Address  Room no 105, Dept. of Anaesthesiology, OPD building, NEIGRIHMS Hospital, Mawdiangdiang, Shillong

East Khasi Hills
MEGHALAYA
793018
India 
Phone  7577055859  
Fax    
Email  priyanka8ap@gmail.com  
 
Source of Monetary or Material Support  
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS)Hospital, Mawdiangdiang, Shillong, East Khasi Hills, Meghalaya, India PIN: 793018 
 
Primary Sponsor  
Name  North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS) 
Address  Mawdiangdiang, Shillong, East Khasi Hills, Meghalaya Pin: 793018  
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 
Dr Priyanka Dev  North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS) Hospital  Operation Theatre no. 2,4,5,6,7 3rd and 4th floor OT complex,
East Khasi Hills
MEGHALAYA 
7577055859

priyanka8ap@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
5th Institutional Ethics Committee, NEIGRIHMS   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, (2) ICD-10 Condition: N10||Acute pyelonephritis, (3) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (4) ICD-10 Condition: H712||Cholesteatoma of mastoid, (5) ICD-10 Condition: H044||Chronic inflammation of lacrimal passages, (6) ICD-10 Condition: H701||Chronic mastoiditis, (7) ICD-10 Condition: M864||Chronic osteomyelitis with draining sinus, (8) ICD-10 Condition: Q544||Congenital chordee, (9) ICD-10 Condition: N130||Hydronephrosis with ureteropelvicjunction obstruction, (10) ICD-10 Condition: H260||Infantile and juvenile cataract, (11) ICD-10 Condition: O||Medical and Surgical, (12) ICD-10 Condition: M866||Other chronic osteomyelitis, (13) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, (14) ICD-10 Condition: N471||Phimosis, (15) ICD-10 Condition: Q532||Undescended testicle, bilateral, (16) ICD-10 Condition: Q531||Undescended testicle, unilateral, (17) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group-A: Oral Melatonin   Approximately 30-40 minutes prior to induction of anesthesia, single dose of oral premedication will be given to patients in Group A (Melatonin 0.5mg/kg) by the anesthesiologist (not included in the study) who will prepare the drug according to the code generated by the computer. The coded drugs will be administered by the same anesthetist who will only know the coded number and not the drug given.  
Comparator Agent  Group-B: Oral Midazolam  Approximately 30-40 minutes prior to induction of anesthesia, single dose of oral premedication will be given to patients in Group B (Midazolam 0.5mg/kg) by the anesthesiologist (not included in the study) who will prepare the drug according to the code generated by the computer. The coded drugs will be administered by the same anesthetist who will only know the coded number and not the drug given. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Patients undergoing general anaesthesia.
ASA physical status I &II


 
 
ExclusionCriteria 
Details  Patient’s parent refusal
Patient with known allergy to the drugs used in the study
Hemodynamic instability.
Patients with significant cardiac, respiratory and hepatic dysfunction
• Patients with history of agitation or on melatonin or midazolam
 
 
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 
To compare the anxiety levels preoperatively and emergence delirium postoperatively
 
Preoperative and postoperative 2hrs
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the intraoperative hemodynamic changes, incidence of complications, parent’s anxiety level
 
Intraoperative 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   01/04/2025 
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)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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 prospective, randomized, comparative study will be conducted on children aged 3-12 years scheduled for elective or emergency surgeries requiring general anesthesia. Patients will be grouped into two groups by simple random method (n=55).

Approximately 30-40 minutes prior to induction of anesthesia, oral premedication will be given to patients in each group, Group A (n=55, Melatonin 0.5mg/kg) and Group B (n=55, Midazolam 0.5mg/kg) by the anesthesiologist (not included in the study) who will prepare the drug according to the code generated by the computer in the preoperative holding area. The coded drugs will be administered by separate anesthetist who will only know the coded number and not the drug given. The patients will be monitored of noninvasive blood pressure, heart rate, respiratory rate, and SpO2. Anxiety and sedation scores will be assessed just prior to administration and at 15 min and 30 min after the drug administration.

In the operating room, intravenous access will be secured and then general anaesthesia will be induced with inj. Fentanyl 2mcg/kg IV, inj. Propofol 2mg/kg IV and inj rocuronium 0.5mg/kg IV. Airway will be secured with intubation with endotracheal tube and anaesthesia will be maintained with sevoflurane (1.2-1.5 MAC) and Air: oxygen (50:50) and intermittent inj.rocuronium 0.1mg/kg IV. Towards the end of the surgery, Inj. Paracetamol 10mg/kg IV and inj. Ondansatron 0.1mg/kg IV will be given. Patients will be reversed prior to completion of the surgery with inj. Neostigmine 0.05mg/kg IV and inj. Glycopyrrolate 0.01mg/kg IV. Once patient is extubated, patient is transferred to PACU where patient will be monitored for the vitals. Anxiety, sedation and emergence delirium scores will be noted immediately on receiving in the PACU and the after 15mins and 30mins. Any side-effects will also be noted and will be treated immediately.


 
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