| CTRI Number |
CTRI/2022/11/046959 [Registered on: 01/11/2022] Trial Registered Prospectively |
| Last Modified On: |
22/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
the study is to compare the intubating conditions between succinylcholine, the gold standard drug for rapid sequence induction and rocuronium after treatment with magnesium sulphate which makes the action of rocuronium similar to that of succinylcholine |
|
Scientific Title of Study
|
Comparison of intubating conditions during rapid sequence induction between rocuronium with magnesium sulphate pretreatment and succinylcholine in patients undergoing elective surgery under general anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nivedha |
| Designation |
Post graduate trainee |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
ABVIMS Dr RML Hospital,Baba Kharak Singh road,
New Delhi-110001
Central
DELHI
110001
India |
| Phone |
8072533653 |
| Fax |
|
| Email |
nivedha196@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfDrNisha Kachru |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
ABVIMS Dr RML Hospital,Baba Kharak Singh road,
New Delhi-110001
Central
DELHI
110001
India |
| Phone |
9810488435 |
| Fax |
|
| Email |
nishakachru@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Nivedha |
| Designation |
Post graduate trainee |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
ABVIMS Dr RML Hospital,Baba Kharak Singh road,
New Delhi-110001
Central
DELHI
110001
India |
| Phone |
08072533653 |
| Fax |
|
| Email |
nivedha196@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ABVIMS Dr RML Hospital |
| Address |
ABVIMS Dr RML Hospital,Baba Kharak Singh road,
New Delhi-110001 |
| 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 |
| nivedha |
ABVIMS & Dr RML Hospital |
Department of Anaesthesia,ABVIMS Dr RML Hospital,Baba Kharak Singh road,
New Delhi-110001
Central
DELHI |
08072533653
nivedha196@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 |
| Healthy Human Volunteers |
Age18-60 years
ASA physical status I & II
Body mass index 18.5-24.9 kg/m2
Mallampati grade 1 & 2
surgery under general anaesthesia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Rocuronium after magnesium sulphate pretreatment |
Magnesium sulphate will be given to the patient over 15 minutes before rocuronium and intubation is performed |
| Intervention |
succinylcholine with saline pretreatment |
succinylcholine will be given to patients after pretreatment with saline and intubation is performed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I & II
Body mass index 18.5-24.9 kg/m2
Mallampati grade 1 & 2
surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
refusal of consent
emergency surgery
anticipated difficult airway
pregnant or breastfeeding patients
patients with hepatic, renal metabolic or neuromuscular disorders
allergic to study drugs
patients receiving drugs that influence neuromuscular functions |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the intubating conditions during rapid sequence intubation using Coopers criteria |
intubating conditions will be graded as
8-9 : excellent
6-7 :good
3-5:fair
0-2:poor |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the hemodynamic parameters:heart rate,systolic,diastolic blood pressure amd mean arterial pressure,Sp02 in both groups at following intervals
2.To study the side effects : muscle pain, burning sensation,nausea,vomiting
|
baseline (T0)
before intubation (Ti)
1 minute after intubation(T1)
3 minutes after intubation (T3)
5 minutes after intubation(T5)
|
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
10/11/2022 |
| 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
|
Trial not yet started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Trial not yet started |