| CTRI Number |
CTRI/2024/05/068151 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of magnesium sulphate and placebo on neuromuscular blockade reversal during emergence from anaesthesia in patients undergoing general anaesthesia for elective surgery. |
|
Scientific Title of Study
|
Effect of Magnesium sulphate on Vecuronium induced neuromuscular blockade reversal using Neostigmine: A randomized, single-blind study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dipak Bhuyan |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Deoghar |
| Address |
Department of Anaesthesiology, All India Institute of Medical Sciences, Deoghar, Devipur, Deoghar, Jharkhand.
Deoghar
JHARKHAND
814152
India |
| Phone |
8876025680 |
| Fax |
|
| Email |
drdipakbhuyan07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sanjay Kumar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Deoghar |
| Address |
Department of Anaesthesiology, All India Institute of Medical Sciences, Deoghar, Devipur, Deoghar, Jharkhand.
Deoghar
JHARKHAND
814152
India |
| Phone |
7063956225 |
| Fax |
|
| Email |
drsanjayaiims2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dipak Bhuyan |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Deoghar |
| Address |
Department of Anaesthesiology, All India Institute of Medical Sciences, Deoghar, Devipur, Deoghar, Jharkhand.
JHARKHAND
814152
India |
| Phone |
8876025680 |
| Fax |
|
| Email |
drdipakbhuyan07@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Deoghar, Devipur, Deoghar, Jharkhand. PIN - 814152, Country - India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Deoghar |
| Address |
Department of Anaesthesiology, All India Institute of Medical Sciences, Deoghar, Devipur, Deoghar, Jharkhand, India
PIN - 814152 |
| 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 Dipak Bhuyan |
All India Institute of Medical Sciences, Deoghar |
Operation theatre complex, All India Institute of Medical Sciences, Deoghar, Devipur.
Deoghar, Jharkhand
PIN - 814152
Deoghar
JHARKHAND |
8876025680
drdipakbhuyan07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC OF AIIMS DEOGHAR |
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 |
Dose - 2g of magnesium sulphate in 100mL of 0.9% normal saline
Route - Intravenous (I.V)
Duration - Slowly over 10 minutes
Frequency - Only once, 15 mintues before induction of general anaesthesia |
| Comparator Agent |
Normal saline |
Dose - 100mL of 0.9% normal saline
Route - Intravenous (I.V)
Duration - Slowly over 10 minutes
Frequency - Only once, 15 mintues before induction of general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. BMI 18.5 - 29.99 kg/sq metre
2. ASA physical status 1 and 2 |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Hyper and hypomagnesemia
3. Pregnancy
4. Cardiac disease
5. Neuromuscular disease (myasthenia gravis, muscular dystrophy, upper motor neuron lesions)
6. Special group of population (notified tribals, jail inmates, etc) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the duration of neuromuscular reversal time (by NMT monitoring) of magnesium sulphate and placebo groups.
Parameters - 1. Train-of-four count (TOFC), 2. Train-of-four ratio (TOFR) |
15 minutes before intubation, 10 minutes before intubation, 5 minutes before intubation, Immediately after intubation, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and so on. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the shifting time from OT to PACU of the two groups
2. To compare the need of supplemental vecuronium dose requirement among the groups. |
Time of reversal administration, 1 min after reversal, 2 mins, 3 mins, 4 mins, 5 mins, 10 mins, 15 mins, 20 mins. |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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)
|
10/06/2024 |
| 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)
|
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
|
Participants who are included in the study will undergo routine induction of general anaesthesia with endotracheal intubation. 15 minutes prior to induction of general anaesthesia, the "study drug" will be administered to the participant and monitored. General anaesthesia will be induced by Propofol as induction agent with Fentanyl as adjuvant and muscle relaxant Vecuronium, premedication with Midazolam. Neuromuscular monitoring will be done with Acceleromyography using NMT monitoring to record the Train-of-four count and Train-of-four ratio.
This study is being done to find effect of magnesium sulphate on neuromuscular reversal using neostigmine in a vecuronium induced patient undergoing general anaestheia. |