| 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
|
|
|
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
|
|
|
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. |