| CTRI Number |
CTRI/2025/12/099180 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| 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
|
A clinical study examining whether magnesium sulfate can help reduce agitation and confusion in children as they wake up from anesthesia after lower-abdominal surgery. |
|
Scientific Title of Study
|
Effect of magnesium sulphate on emergence delirium in pediatric patient undergoing infraumbilical surgery: a double blinded 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 |
Tanveer Singh Aulakh |
| Designation |
Junior Resident |
| Affiliation |
AIIMS PATNA |
| Address |
B5A OT Complex IPD building Department of Anaesthesiology All
India Institute of Medical Sciences Patna Phulwarisharif Patna
BIHAR India
Patna
BIHAR
801507
India
Patna
BIHAR
801507
India |
| Phone |
6283041180 |
| Fax |
|
| Email |
tanveersingh1300@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kunal Singh |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences Patna |
| Address |
Room no. 501 B5A OT Complex IPD building Department of
Anaesthesiology All India Institute of Medical Sciences Patna
Phulwarisharif Patna BIHAR India
Patna
BIHAR
801507
India
Patna
BIHAR
801507
India |
| Phone |
9411514945 |
| Fax |
|
| Email |
drsinghkunal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kunal Singh |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences Patna |
| Address |
Room no. 501 B5A OT Complex IPD building Department of
Anaesthesiology All India Institute of Medical Sciences Patna
Phulwarisharif Patna BIHAR India
Patna
BIHAR
801507
India
Patna
BIHAR
801507
India |
| Phone |
9411514945 |
| Fax |
|
| Email |
drsinghkunal@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Patna, Phulwarisharif, Patna,Bihar,India
PIN 801507
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Patna |
| Address |
All India Institute of Medical Sciences Patna, Phulwarisharif, Patna,
Bihar, PIN 801507 |
| 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 Tanveer Singh Aulakh |
All india institue of medical sciences, patna |
B5A OT complex, Department of
Anaesthesiology, All
India Institute of
Medical Sciences
Patna, Phulwarisharif
Patna BIHAR
Patna
BIHAR
Patna
BIHAR |
6283041180
tanveersingh1300@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences Patna Institutional Ethics Committee |
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 |
Magnesium Sulphate Group |
Just before giving general
anesthesia, intervention patients
will be given magnesium sulphate
bolus at 30 mg/kg over 15 minutes i.e. 2mg/kg/min just before induction and patient is monitored in intraoperative and postoperative till 60 minutes for emergence delirium.
|
| Comparator Agent |
Normal Saline Group |
Just before giving general
anesthesia, intervention patients
will be given equal volume of 0.9% Normal Saline over 15 minutes i.e. just before induction and patient is monitored in intraoperative and postoperative till 60 minutes for emergence delirium |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1.Paediatric patient age 2-8 years
2. Patient scheduled for elective infraumbilical surgeries
3. ASA I and II |
|
| ExclusionCriteria |
| Details |
1.History of hypersensitivity
2. Neurological disorders, developmental delay, or psychiatric illness
3. pre-existing electrolyte imbalance
4. cardiac conduction abnormalities
5. Currently of anti-epileptic drugs
6. Neuromuscular disease
pulmonary, hepatobiliary or renal disease.. |
|
|
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 assess the effects of Magnesium Sulphate on the incidence of emergence
delirium in pediatric patients undergoing elective infraumbilical surgery using PAED score |
Just before induction till postoperative period of 60 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess severity of emergence delirium using PAED score.
2. To assess and evaluate post operative pain score using FLACC score.
3. To evaluate need of rescue sedatives.
4. To assess the time of emergence.
5. To see and evaluate any adverse events. |
Just before induction till postoperative period of 60 minutes |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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)
|
Not Yet Recruiting |
| 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
|
Magnesium sulphate, an NMDA receptor antagonist, possesses sedative,
analgesic, and anti-agitation properties. Emergence delirium (ED) is a common postoperative
complication in children receiving sevoflurane anaesthesia, especially after infraumbilical
surgeries, leading to agitation, restlessness, and risk of injury. Current management often relies
on opioids and sedatives, which increase side effects.
Pre-emptive intravenous magnesium sulphate may reduce the incidence and severity of ED,
decrease analgesic requirements, and improve recovery profiles in children. |