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CTRI Number  CTRI/2024/06/068750 [Registered on: 12/06/2024] Trial Registered Prospectively
Last Modified On: 12/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparison of preventive effects of diclofenac vs ibuprofen on succinylcholine induced pain in precurarized patients  
Scientific Title of Study   Comparison of prophylactic effects of diclofenac vs ibuprofen on succinylcholine induced myalgia in precurarized patients. Randomized, controlled, double blinded 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 HIYA CHATURVEDI 
Designation  PG 1ST YEAR RESIDENT 
Affiliation  School of Medical Sciences and Research 
Address  Department of Anesthesiology, School of Medical Sciences and Research, plot no 32, 34, Knowledge park 3, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone    
Fax    
Email  chiya566@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mahendra Kumar 
Designation  Professor 
Affiliation  School of Medical Sciences and Research 
Address  Department of Anesthesiology, School of Medical Sciences and Research, plot no 32, 34, Knowledge park 3, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  8287188449  
Fax    
Email  mahendra.kumar@sharda.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr HIYA CHATUEVDI 
Designation  pg 1st year resident anaesthesia 
Affiliation  School of Medical Sciences and Research 
Address  Department of Anesthesiology, School of Medical Sciences and Research, plot no 32, 34, Knowledge park 3, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9205969329  
Fax    
Email  chiya566@gmail.com  
 
Source of Monetary or Material Support  
Sharda Hospital, Department of Anesthesiology, School of Medical Sciences and Research, plot no 32, 34, Knowledge park 3, Greater Noida, Uttar Pradesh 201310  
 
Primary Sponsor  
Name  Sharda Hospital 
Address  Department of Anesthesiology, School of Medical Sciences and Research, plot no 32, 34, Knowledge park 3, Greater Noida, Uttar Pradesh 201310  
Type of Sponsor  Private medical college 
 
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 HIYA CHATURVEDI  sharda hospital, school of medical sciences and research  Department of Anaesthesiology, 2nd floor, b block
Gautam Buddha Nagar
UTTAR PRADESH 
9205969329

Chiya566@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
School of Medical Sciences and ResearchInstitutional Ethics Committee  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  iv diclofenac   iv diclofenac Patients of this group will receive inj diclofenac sodium 75 mg in 100 ml NS as infusion over a period of 10 mins before induction of anesthesia and atracurium 0.05 mg/kg in 5 ml 3 min before succinylcholine administration.  
Comparator Agent  iv ibuprfen  iv ibuorfen Patients of this group will receive inj ibuprofen 400mg 100 ml as infusion over a period of 10 mins before induction of anesthesia and atracurium 0.05 mg/kg in 5 ml 3 min before succinylcholine administration 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients scheduled for any elective surgery under general anesthesia with endotracheal intubation under succinylcholine.
2.ASA class I and II
3.Age 18-60 years
4.Both genders
 
 
ExclusionCriteria 
Details  1. Patients already taking steroids, analgesics, antiemetic, and sedatives preoperatively for any clinical purpose.
2. Patients with past history of chronic pain.
3. Patients having history of endocrine, cardiovascular, renal or CNS disease.
4. Patients allergic to study drugs.
5. Contraindication of succinylcholine e.g. High potassium level, extensive burn or soft tissue injury.
6.BMI more than 30
 
 
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 the effects of premedication with two drugs (diclofenac vs ibuprofen) on succinylcholine induced postoperative myalgia in precurarized patients.  72 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
a) To observe and compare the grades of fasciculations.
b) To compare the changes in the levels of serum creatinekinase
c) To assess the relationship of fasciculations with serum creatinekinase and myalgia
d) To compare the hemodynamic parameters (HR, SBP, DBP, MAP) perioperatively in four groups
 
72 hrs 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2/ Phase 3 
Date of First Enrollment (India)   07/07/2024 
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="1"
Months="6"
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  

Succinylcholine is a depolarizing neuromuscular blocking agent that causes skeletal muscle relaxation for a very short period. The onset of action of this drug is very quick and quality of muscle relaxation is usually excellent. The drug is used to achieve muscle relation for tracheal intubation and short surgical procedures.

Although it provides an excellent relaxation but its use is associated with various side effects like rise in serum potassium levels, fasciculations of muscle fibers and post operative myalgia. The incidence of postoperative myalgia due to succinylcholine varies, being as high as 90% and generally thought to be approximately 50%.[1][2]

Fasciculations of muscle fibers is due to uncoordinated contractions of muscle fibers that may result in post operative myalgia. The mechanism of postoperative myalgia has not completely been elucidated. It has been proposed that the pain occurs due to muscle damage produced by shearing forces associated with the fasciculations at the onset of block.[2] Studies have shown the possible development of microdamage at the muscle fibres.[3]

Many studies have shown rise in serum creatine kinase that might be because of some degree of trauma of muscle fibers because of fasciculations.[4]

Post operative myalgia is distressing to the patient therefore it is essential to control fasciculations and post operative myalgia following use of succinylcholine.

Various drugs and techniques has been employed to control succinylcholine induced fasciculations and postoperative myalgia like precurarization with nondepolarizing muscle relaxants, self-taming with succinylcholine itself, preoperative stretching exercises[5], magnesium sulfate[6], calcium gluconate[7], benzodiazepines[8] and nonsteroidal anti-inflammatory drugs like diclofenac sodium[9] etc. For precurarization gallamin, atracurium[10], pancuronium and rocuronium[11] have been used in very small doses with variable results.

Recently diclofenac sodium has been used by Tirkey et al (2022) to control succinylcholine induced myalgia.[9]

Intravenous preparation of ibuprofen another nonsteroidal anti-inflammatory drug has been made available recently for clinical use but it has not been used to assess its effects on succinylcholine induced fasciculations and postoperative myalgia.

In the present study the effect of intravenous diclofenac sodium and ibuprofen will be assessed and compared on fasciculations and post operative myalgia in precurarized patients requiring endotracheal intubation for general anesthesia.                            
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