| CTRI Number |
CTRI/2025/07/091952 [Registered on: 29/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| 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
|
Comparing two muscle relaxants, Cis-atracurium and Atracurium, to check which provides better conditions for inserting a breathing tube and keeps childrens vital signs more stable during surgery |
|
Scientific Title of Study
|
A comparative study between Cis-atracurium and Atracurium for assessment of intubating conditions and hemodynamic stability in pediatric patients undergoing surgery: A randomised double 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 |
Abhishek Hansdak |
| Designation |
Junior Resident |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Anesthesiology, Rajendra Institute of Medical Sciences, Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
9572764664 |
| Fax |
|
| Email |
abhishekhansdak001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Kumar Tiwari |
| Designation |
Additional Professor |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Anesthesiology, Rajendra Institute of Medical Sciences, Bariatu
Ranchi
JHARKHAND
834009
India |
| Phone |
9661883797 |
| Fax |
|
| Email |
drpkt80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Anesthesiology, Rajendra Institute of Medical Sciences, Bariatu
Ranchi
JHARKHAND
834009
India |
| Phone |
7004993204 |
| Fax |
|
| Email |
mukeshgmch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology,Rajendra Institute of Medical Sciences,Bariatu,Ranchi, Jharkhand,India Pin code 834009 |
|
|
Primary Sponsor
|
| Name |
Rajendra Institute of Medical Sciences |
| Address |
Department of Anesthesiology, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand 834009 |
| 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 Abhishek Hansdak |
Rajendra Institute of Medical Sciences. |
Department of Anesthesiology, Pediatric Surgery Operation Theatre, RIMS, Bariatu, Ranchi, Jharkhand, India Pin 834009
Ranchi
JHARKHAND |
9572764664
abhishekhansdak001@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 |
| Comparator Agent |
Endotracheal intubation using Atracurium |
Patient of age 3 to 12 years posted for surgery requiring general anesthesia will be given premedication intravenously with inj. midazolam 0.03mg/kg and inj. glycopyrrolate 0.004mg/kg. Pre-oxygenation will be done with 100% oxygen for 3 minutes. Intravenous general anesthesia will be induced with inj. fentanyl 1.5-2mcg/kg and inj. propofol 2mg/kg. After adequate induction, inj. atracurium will be given at a dose of 0.5mg/kg following which bag and mask ventilation will done for 3 minutes. Under direct laryngoscopy patient will be intubated with appropriate size endotracheal tube and intubating conditions and hemodynamics will be assessed. Expected duration of this intervention will be around 8-10 minutes. Inj atracurium will be repeated intravenously every 25 min at the dose of 0.1mg/kg till the end of surgery. |
| Intervention |
Endotracheal intubation using Cis-atracurium |
Patient of age 3 to 12 years posted for surgery requiring general anesthesia will be given premedication intravenous with inj. midazolam 0.03mg/kg and inj. glycopyrrolate 0.004mg/kg. Pre-oxygenation will be done with 100% oxygen for 3 minutes. Intravenous general anesthesia will be induced with inj. fentanyl 1.5-2mcg/kg and inj. propofol 2mg/kg. After adequate induction inj. cis-atracurium will be given at a dose of 0.2mg/kg following which bag and mask ventilation will be done for 3 minutes. Under direct laryngoscopy patient will be intubated with appropriate size endotracheal tube and intubating conditions and hemodynamics will be assessed. Expected duration of this intervention will be around 8-10 minutes. Inj cis atracurium will be repeated intravenously every 25 min at dose of 0.05mg/kg till the end of surgery. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
a Patient’s guardian consent
b Age group 3 to 12 years
c ASA grade 1 and 2
d Patient posted for surgery requiring general anaesthesia and endotracheal intubation
e Expected duration of surgery should be less than 90 minutes |
|
| ExclusionCriteria |
| Details |
a ASA grade 3 and 4
b Anticipated difficult airway
c Comorbid conditions
d Upper and lower respiratory tract infection
e Known history of allergy to any of the study drug |
|
|
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 compare effectiveness of Cis-atracurium and Atracurium at dose of 0.2mg/kg and 0.5mg/kg respectively with regards to intubating conditions. Intubating conditions will be assessed using Cooper et al scoring system. |
3minutes after injection of muscle relaxant, laryngoscopy will be performed.
At the time of laryngoscopy, and just after intubation, intubating conditions will be assessed using Cooper et al scoring system. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess hemodynamic stability. Systolic Blood pressure, Diastolic blood pressure, Mean Arterial Pressure, Heart rate will be monitored at given time points. |
1. baseline parameters before induction
2. 3minutes after preoxygenation with 100 percent oxygen & Intravenous injection of Inj.Propofol.
3. 3minutes after injection of muscle relaxant but before intubation.
4. Immediately after intubation
5. After endotracheal intubation hemodynamic parameters will be assessed at 5minutes, 10minutes, 15minutes, 20minutes, 25minutes, 30minutes 45minutes, 60minutes, 75minutes, 90minutes intraoperatively |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
06/08/2025 |
| 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="0"
Months="4"
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
|
Muscle relaxant is crucial component of general anesthesia which facilitates laryngoscopy and endotracheal intubation, prevents voluntary and reflex movements preventing vocal cord damage. Cis-atracurium and Atracurium are Non depolarising muscle relaxant. Cis-atracurium is 4 times more potent than Atracurium with their ED95 being 0.05mg/kg and 0.23mg/kg respectively. The study is to compare the effectiveness of Cis-atracurium and Atracurium at dose of 4ED95 and 2ED95 which is 0.2mg/kg and 0.5mg/kg respectively with regards to intubating conditions and hemodynamic stability. |