跳至主要内容
临床试验/CTRI/2024/06/068750
CTRI/2024/06/068750尚未招募2/3 期

Comparison of prophylactic effects of diclofenac vs ibuprofen on succinylcholine induced myalgia in precurarized patients. Randomized, controlled, double blinded study

Sharda Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月7日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
To compare the effects of premedication with two drugs (diclofenac vs ibuprofen) on succinylcholine induced postoperative myalgia in precurarized patients.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • Patients already taking steroids, analgesics, antiemetic, and sedatives preoperatively for any clinical purpose.
  • Patients with past history of chronic pain.
  • Patients having history of endocrine, cardiovascular, renal or CNS disease.
  • Patients allergic to study drugs.
  • Contraindication of succinylcholine e.g. High potassium level, extensive burn or soft tissue injury.
  • 6.BMI more than 30.

结局指标

主要结局

To compare the effects of premedication with two drugs (diclofenac vs ibuprofen) on succinylcholine induced postoperative myalgia in precurarized patients.

时间窗: 72 hrs

次要结局

  • a) To observe and compare the grades of fasciculations.(b) To compare the changes in the levels of serum creatinekinase)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr HIYA CHATURVEDI

School of Medical Sciences and Research

研究点 (1)

Loading locations...

相似试验

Comparison of preventive effects of diclofenac vs... | 临床试验