| CTRI Number |
CTRI/2024/01/062064 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
01/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The effect of melatonin pre-treatment on the consumption of inhaled anaesthetic in children undergoing planned surgery. |
|
Scientific Title of Study
|
To evaluate the effect of melatonin premedication
on Bispectral Index guided sevoflurane
consumption in pediatric surgery: 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 |
Pulkit Johar |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anaesthesiology and Critical Care AIIMS Rishikesh Virbhadra Road Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9877307543 |
| Fax |
|
| Email |
pulkitjohar23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yashwant Singh Payal |
| Designation |
Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anaesthesiology and Critical Care AIIMS Rishikesh Virbhadra Road Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9411789762 |
| Fax |
|
| Email |
dryspayal05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yashwant Singh Payal |
| Designation |
Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anaesthesiology and Critical Care AIIMS Rishikesh Virbhadra Road Rishikesh
UTTARANCHAL
249203
India |
| Phone |
9411789762 |
| Fax |
|
| Email |
dryspayal05@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care, AIIMS Rishikesh, Rishikesh, Uttarakhand, India, 249203 |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Pulkit Johar |
AIIMS Rishikesh |
Level 6 OT Complex, Department of Anaesthesiology, AIIMS Rishikesh, Virbhadra Road, Rishikesh, 249203
Dehradun
UTTARANCHAL |
9877307543
pulkitjohar23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Melatonin |
Group M - Melatonin 0.2 mg per Kg (maximum dose 10mg) as syrup reconstituted with
honey to a volume of 5 ml 1 hour before surgery with sips of water |
| Comparator Agent |
Placebo |
Group C - 5 ml honey 1 hour prior to surgery with sips of water |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists grade I or II paediatric patients (aged from 2 to 8 years) undergoing elective surgical procedure under general anaesthesia (Duration of procedure ranging from 30 minutes to 2 hours). |
|
| ExclusionCriteria |
| Details |
Unwillingness to participation.
Paediatric patients undergoing elective surgical procedure under general anaesthesia from department of Cardiothoracic and Neurosurgery.
Patients with known comorbidities (renal or hepatic derangement, Asthma, TB, etc).
Allergy to Study drugs or Honey.
History of epileptic seizures, psychoactive medications, neurological disorders, or trauma. |
|
|
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 |
To assess the effect of melatonin premedication on total sevoflurane consumption.
Inhaled sevoflurane requirement (volume%) will be measured to maintain BIS readings between 40 to 50 using Dion method. |
0 minutes, 10 minutes, 20 minutes, 30 minutes, 40 minutes, 50 minutes, 60 minutes, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes and 120 minutes after induction of anaesthesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect on sedation scores (Ramsay Sedation Scale). |
0 minutes, 30 minutes, 60 minutes after premedication and at induction of anaesthesia. |
| To assess the effect on anxiety scores (Modified yale preoperative Anxiety Scale). |
0 minutes, 30 minutes, 60 minutes after premedication and at induction of anaesthesia. |
| To assess the effect on Pain scores (FLACC Scale) during post operative period. |
0 minute, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 12 hours, 18 hours, 24 hours in post operative period. |
To assess the Duration of first analgesic requirement in post operative period.
|
Post operative period.
|
| To assess the effect on Total analgesic requirement during post operative period. (Injection Fentanyl 0.5 mcg per kg IV). |
Till 24 hours in post operative period. |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
01/02/2024 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| 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 study explores the use of melatonin as a premedication in pediatric patients undergoing general anesthesia, aiming to assess its impact on the consumption of inhalational sevoflurane. General anesthesia induces a coma-like state, and while effective, its agents come with inherent side effects. Various drugs, including melatonin, have been considered as adjuncts to minimize the required dosage of these agents. Melatonin, a hormone secreted by the pineal gland, has demonstrated anesthetic and antinociceptive properties. Despite its potential benefits, no prior research has systematically investigated the impact of melatonin premedication on sevoflurane consumption in pediatric patients. The current study addresses this gap by evaluating the effects of melatonin premedication on total sevoflurane consumption, utilizing bispectral index (BIS) to measure the depth of anesthesia and ensure consistent appropriateness throughout the procedure. By bridging this research gap, the study aims to contribute to the advancement of pediatric anesthesiology and enhance the overall quality of care for young patients undergoing surgical procedures. |