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CTRI Number  CTRI/2024/03/063703 [Registered on: 06/03/2024] Trial Registered Prospectively
Last Modified On: 04/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the efficacy of two different dosage of cisatracurium for rapid sequence intubation. 
Scientific Title of Study   Comparative study of the efficacy of two different dosage of cisatracurium for endotracheal intubation during rapid sequence induction of anesthesia. A prospective randomized 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  DR B Kesava Kumar 
Designation  Professor and Head 
Affiliation  Sri Venkateswara Institute of Medical Sciences 
Address  Department of Anaesthesiology, SVIMS, Alipiri, Tirupati.
Alipiri,Chittoor,Andhra pradesh,517507.
Chittoor
ANDHRA PRADESH
517507
India 
Phone  08681002995  
Fax    
Email  kesavakumartamil@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR B Kesava Kumar 
Designation  Professor and Head 
Affiliation  Sri Venkateswara Institute of Medical Sciences 
Address  Department of Anaesthesiology, SVIMS, Alipiri, Tirupati.
Alipiri,Chittoor,Andhra pradesh,517507.
Chittoor
ANDHRA PRADESH
517507
India 
Phone  08681002995  
Fax    
Email  kesavakumartamil@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR B Kesava Kumar 
Designation  MBBS, Post graduation(MD) Anaesthesiology 
Affiliation  Sri Venkateswara Institute of Medical Sciences 
Address  Department of Anaesthesiology, SVIMS, Alipiri, Tirupati.
Chittoor,Andhra pradesh,517507.
Chittoor
ANDHRA PRADESH
517507
India 
Phone  08681002995  
Fax    
Email  kesavakumartamil@gmail.com  
 
Source of Monetary or Material Support  
Sri venkateswara Institute of Medical Sciences, Alipiri Road, Tirupati, Chittoor , Andhra Pradesh, 517507 
 
Primary Sponsor  
Name  Sri Venkateswara Institute of Medical Sciences 
Address  Alipiri Road, Tirupati, Chittoor , Andhra Pradesh, 517507 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aloka Samantaray Professor and Head Department of Anaesthesiology  Sri Venkateswara Institute of Medical Sciences  Department of Anaesthesiology, Svims, Alipiri, Tirupati, Chittoor district, Andhra pradesh, 517507.
Chittoor
ANDHRA PRADESH 		 9493547653

aloksvims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Sri Venkateswara Institute of Medical Sciences, Tirupati  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cisatracurium of dose 0.20 mg/kg  After preoxygenation with 100% oxygen for 3 minutes, cisatracurium in 4 times ED95 dose [0.20 mg/kg] was given intravenously as a bolus dose for rapid sequence intubation. 
Comparator Agent  Cisatracurium of dose 0.30 mg/kg  After preoxygenation with 100% oxygen for 3 minutes, cisatracurium in 6 times ED95 dose [0.30 mg/kg] was given intravenously as a bolus dose for rapid sequence intubation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)American Society of Anesthesiology (ASA) physical status I and II.
2)Patient undergoing elective surgery lasting more than two hours under general anaesthesia.
3)Patients with no known neuromuscular diseases.
4)Patient not undergoing treatment with medications known to interfere with neuromuscular transmission.
5)Patient willing to give the written consent to participate in the study.
 
 
ExclusionCriteria 
Details  1)Patients who refuse to give consent to the study.
2)Patients who is a known smoker, asthmatic and COPD.
3)Patients with anticipated difficulty airway.
4)Patients with known allergies to the study drug.
5) Pregnant and lactating women.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the time of onset of action of two different doses of cisatracurium for
rapid sequence induction of anesthesia as an indicator of efficacy.
 		 1)Onset of neuromuscular block will be assessed with TOF stimulus every 12 seconds until loss of twitch response (TOF-0).
2)The blood pressure, heart rate will be recorded every minute for 10 minutes, followed by monitoring every five minutes after endotracheal intubation till the end of surgery. But statistical comparision will be done up to 30 minutes.
3)After the endotracheal tube fixation, TOF stimulation will be recorded every 5 minutes until the return of two twitches (TOF-25).  
 
Secondary Outcome  
Outcome  TimePoints 
• To compare the duration of action of the two doses of cisatracurium administered for the rapid sequence induction.
• To compare the intubating conditions during endotracheal intubation using Copenhagen consensus conference scoring system.
• To compare the hemodynamic changes
• To document any adverse effects.
 		 The blood pressure, heart rate and pulse oximetry will be recorded every minute for 10 minutes following induction of anesthesia, followed by monitoring every five minutes after endotracheal intubation till the end of surgery but documentation for statistical comparision will be done up to 30 minutes.
The time from the onset of muscle relaxation (TOF-0), to the spontaneous recovery time represents the duration of action of the intubating dose of muscle relaxant.  
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 3 
Date of First Enrollment (India)   15/03/2024 
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="0"
Months="3"
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   Rapid sequence induction of anaesthesia, commonly used in emergency surgeries to secure airway rapidly by endotracheal intubation to minimize the risk of aspiration and hypoxia.

Succinylcholine and large doses of rocuronium has been used as a standard drug for rapid sequence induction of anaesthesia. However, many adverse effects associated with succinylcholine and Rocuronium prompted the search for alternate drug.

The dose of atracurium required for rapid sequence induction can be associated with significant cardiopulmonary adverse events due to histamine release. Cisatracurium , a sterioisomer of atracurium shares the same metabolic pathway as atracurium with minimal release of histamine after bolus administration.

Hence this study aims to compare the efficacy and duration of two different doses of cisatracurium in combination with fentanyl, propofol and lignocaine for rapid sequence induction of anesthesia in patients undergoing elective surgical procedures.
 
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