| CTRI Number |
CTRI/2024/04/066229 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To detect a better adjuvant between magnesium sulphate and lignocaine for pretreatment with rocuronium |
|
Scientific Title of Study
|
Comparison 0f pretreatment with magnesium sulphate versus lignocaine on intense neuromuscular blockade of rocuronium in elective surgeries: a randomized control 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 |
Dr Arhan Pasha |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Department of Anaesthesiology
All India Institute Of Medical Sciences
Virbhadra Road
Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
8431866063 |
| Fax |
|
| Email |
arhanhims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Gupta |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Medical Sciences, Rishikesh |
| Address |
Department of Anaesthesiology
All India Institute Of Medical Sciences
Virbhadra Road
Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9811894899 |
| Fax |
|
| Email |
priyanka.anaes@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Gupta |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Medical Sciences, Rishikesh |
| Address |
Department of Anaesthesiology
All India Institute Of Medical Sciences
Virbhadra Road
Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9811894899 |
| Fax |
|
| Email |
priyanka.anaes@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| Department Of Anesthesiology
AIIMS Rishikesh
Virbhadra road,Rishikesh
Uttarakhand, Dehradun
249201
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NA |
| Type of Sponsor |
Other [NIL] |
|
|
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 Arhan Pasha |
All India Institute Of Medical Sciences, Rishikesh |
OT Complex, level 6
Department of Anesthesiology AIIMS,Rishikesh
Dehradun
UTTARANCHAL |
8431866063
arhanhims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
Group A IV MAGNESIUM SULPHATE |
The patient will receive Magnesium Sulphate IV (60mg/kg) diluted in 100ml Normal Saline over 10 minutes, 15 minutes before giving IV rocuronium (0.6mg/kg) and Normal Saline in 10ml syringe 2 minutes before giving rocuronium(0.6mg/kg) |
| Comparator Agent |
Group B IV Lignocaine |
The patient will receive IV lignocaine 2mg/kg in a 10ml syringe 2 mins before giving rocuronium (0.6mg/kg) and 100ml normal saline over 10 minutes, 15 minutes before giving rocuronium(0.6mg/kg) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society Of Anaesthesiologist (ASA) grading 1-2
2. BMI 18.5-29.9
3. All GA Surgeries lasting for more than 2 hrs |
|
| ExclusionCriteria |
| Details |
1.Refused To Participate In The Study
2.Cardiac Conduction Abnormalities
3.Patients Having Neuromuscular Disease
4.known hepatic and renal dysfunction
5.Allergies to study drugs
6.Patients having electrolyte abnormalities
7.Patients on medications known to alter neuromuscular function
8.Patients having expected difficult mask ventilation or difficult laryngoscopy and intubation
9.Pregnant women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ONSET OF NEUROMUSCULAR BLOCKADE OF ROCURONIUM |
From the time of giving rocurnium to the time of achieving T1(first twitch) less than or equal to 5% |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| HEMODYNAMIC RESPONSE TO LARYNGOSCOPY |
Just before intubation, during laryngoscopy, just after intubation, 5 mins after intubation |
| time of first top-up dose of rocuronium |
TOF Count 2-3 |
| Total cumulative dose of Rocuronium |
At the end of last top-up dose |
| Time of neuromuscular recovery |
TOF ratio more than or equal to 0.9 |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
05/05/2024 |
| 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="0"
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
|
Both Magnesium Sulphate and Lignocaine have been proven to reduce the onset time of neuromuscular blockade of rocuronium as well as reduce the hemodynamic responses during laryngoscopy. Therefore, in this study, we aim to compare these two drugs to discover a more potent adjuvant for rocurnium between magnesium and lignocaine so that the dose of neuromuscular agent rocuronium can be reduced to avoid post operative residual neuromuscular paralysis |