| 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
|
|
|
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
|
|
|
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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