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CTRI Number  CTRI/2021/06/034333 [Registered on: 22/06/2021] Trial Registered Prospectively
Last Modified On: 16/06/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare two drugs for reduction of propofol injection pain 
Scientific Title of Study   Randomised controlled trial to compare cisatracurium versus 2%lignocaine preservative free (xylocard) pretreatment with tourniquet to reduce propofol injection pain 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  BALWINDERJIT SINGH 
Designation  Professor 
Affiliation  Panjab institute of medical sciences Jalandhar 
Address  Department of Anaesthesia,Panjab institute of medical sciences ,Garha road Panjab institute of medical sciences Jalandhar
Department of Anaesthesia , Panjab institute of medical sciences Jalandhar
Jalandhar
PUNJAB
144006
India 
Phone  9814087951  
Fax    
Email  drbalwinder2000@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  BALWINDERJIT SINGH 
Designation  Professor 
Affiliation  Panjab institute of medical sciences Jalandhar 
Address  Department of Anaesthesia,Panjab institute of medical sciences ,Garha road Panjab institute of medical sciences Jalandhar
Department of Anaesthesia , Panjab institute of medical sciences Jalandhar
Jalandhar
PUNJAB
144006
India 
Phone  9814087951  
Fax    
Email  drbalwinder2000@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  BALWINDERJIT SINGH 
Designation  Professor 
Affiliation  Panjab institute of medical sciences Jalandhar 
Address  Department of Anaesthesia,Panjab institute of medical sciences ,Garha road Panjab institute of medical sciences Jalandhar
Department of Anaesthesia , Panjab institute of medical sciences Jalandhar
Jalandhar
PUNJAB
144006
India 
Phone  9814087951  
Fax    
Email  drbalwinder2000@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Anaesthesia Panjab institute of medicalsciences Jalandhar 
 
Primary Sponsor  
Name  Department of Anaesthesia Panjab institute of medical sciences Jalandhar 
Address  Panjab institute of medical sciences Jalandhar 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Balwinderjit Singh  Department of Anaesthesia  Surgical operation theatre room number 5 Main operation theatre complex.
Jalandhar
PUNJAB 
0181-6606000

drbalwinder2000@yahoo.co.in 
Balwinderjit Singh  Department of Anaesthesia Panjab institute of medical sciences Jalandhar  Room no 5 surgical operation theatre Main OT complex Panjab institute of medical sciences Jalandhar
Jalandhar
PUNJAB 
0181-6606000

drbalwinder2000@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
InstitutionalEthicsCommitee  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  In reduction of propofol injection pain 
Comparator Agent  Preservative free 2%lignocaine(xylocard)  In reduction of propofol injection pain 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients posted for elective surgery 
 
ExclusionCriteria 
Details  Patient refusal
Allergy to propofol,
egg
History of cardiovascular, respiratory dysfunction
History of difficult intubation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Efficacy of cisatracurium with 2% xylocard pretreatment to reduce propofol injection pain  Single 
 
Secondary Outcome  
Outcome  TimePoints 
Any adverse effects,(nausea, vomiting, muscle paralysis, diplopia, anaphylaxis) of both these drugs  Single 
Any adverse effects (nausea , vomiting , muscle paralysis, diplopia, anaphylaxis) of cisatracurium and 2%xylocaine preservative free during study cisatracurium  Single 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   22/06/2021 
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="1"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Yet to Publish 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

  AIMS AND OBJECTIVES

 

●       The aim of the present study is to investigate the efficacy of pretreatment with 0.15mg/Kg   cisatracurium in the prevention of propol- associated pain injected 30s before propofol injection with venous occlusion a the forearm. The efficacy of cisatracurium will compared with that of 2% preservative free lidocaine

  MATERIAL AND METHODS

•           This open label prospective, randomized controlled study will be done at PIMS, Jalandhar after approval from institutional ethics committee on 80 patients(40 patients for each group) scheduled to undergo elective non cardiac surgery under general anesthesia of ASA physical status I and II aged 18-65 years.

•       Exclusion Criteria: Patient refusal, Allergy to propofol or egg, limited neck mobility; history of difficult intubation; history of cardiovascular, respiratory, neurological, neuromuscular or psychiatric disease.

•      Patients will be randomly divided into two groups according to computer generated randomization.

•      Group-I:- Pretreatment with 2% Lignocaine 0.5mg/Kg (Preservative free)

•      Group-II: - Pretreatment with 0.15mg/Kg cisatracurium.

•       Patient will be taken to the operative room and ECG, SPO2, NIBP will be recorded.

•      A 20-G cannula will be inserted into the largest visible vein on the radial side, attached to a three-way tap and flushed with Ringer’s lactate solution.

•      A venous occlusion tourniquet will be applied just above the elbow and pretreatment drug will be administered in open label manner. The tourniquet will be released after 30s. Then 0.5mg/kg propofol will be delivered via the intravenous cannula. In order to evaluate pain and determine the possibility of muscle paralysis, patients will be asked “does it hurt?” by the anesthetist at 10s after the initial propofol dose, and at 20s intervals thereafter until unresponsive. Any spontaneous movement of the wrist, elbow or shoulder will be noted. Pain scores will be evaluated by an anesthetist who will be blinded to group assignment and expressed using a four-point scale:

STATISTICAL ANALYSIS

•      Continuous variables will be expressed as mean ±SD or median (range). Categorical variables were described as n (%).

•      Demographic data will be analyzed with one way analysis of variance and Scheffe’s post hoc test, or X2-test.

•       Between- group variation in the incidence of pain will be analyzed using X2-test. Statistical significant will be defined as P<0.05. Statistical analyses will performed with SPSS.

 

 
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