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
|
|
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
|
|
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
â— 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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