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临床试验/CTRI/2024/08/072116
CTRI/2024/08/072116尚未招募3 期

Comparison of prophylactic administration of Ondansetron and Dexmedetomidine for the prevention of post-spinal anaesthesia shivering in lower abdominal surgeries : A randomized controlled trial

Apoorva Singh1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年8月22日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
96
试验地点
1
主要终点
Post spinal anaesthesia shivering

研究概览

简要总结

Post Spinal Anaesthesia Shivering (PSAS) is known to be a frequent complication and has reported incidence of 40-70%. Shivering is defined as the involuntary and oscillatory muscular activities that increase the metabolic rate by two to three folds to maintain the core temperature, with the increment of heat production. The study will be a Randomized controlled double blinded study to compare the efficacy of prophylactic Ondansetron and Dexmedetomidine in the prevention of post spinal shivering in patients undergoing elective lower abdominal surgeries under spinal anaesthesia.

A total number of 96 patients aged 18-60 years of either sex, ASA physical grade I and II who will be undergoing elective lower abdominal surgeries shall be enrolled in the study. The patients will be divided into three groups of 32 each. The study drug will be prepared in a 5 ml syringe by an anaesthesiologist not directly involved in the study to keep the study blinded. Group A will receive Normal saline, Group B will receive 0.1 mg/kg of intravenous Ondansetron and Group C will receive 1 mcg/kg of intravenous Dexmedetomidine. 0.5% of Inj. hyperbaric Bupivacaine will be used for spinal anaesthesia. The operating room temperature will be maintained at an ambient temperature of around 24 degree Celsius to 26 degree Celsius. Vital parameters like temperature, blood pressure, heart rate, SpO2 will be recorded preoperatively and intraoperatively. Time of onset of shivering along with its grade and the disappearance of shivering will be recorded. In case of failure to control shivering by study drugs 0.5 mg/kg of Inj. Tramadol will be used as rescue therapy.

The data collected will be analyzed and interpreted by appropriate statistical method. Quantitative data will be analyzed using Students t test and qualitative data will be analyzed using Chi square test. P value less than 0.05 will be taken as significant.

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

  • Patients of age group 18 to 60 years.
  • Patients of American Society of Anaesthesiologists (ASA) grade I or II.

排除标准

  • Patients with history of allergy to Ondansetron and Dexmedetomidine.
  • Patients with history of diabetes, hypertension, thyroid disorder, cardiovascular, respiratory, renal, hepatic or neurological disease.
  • Patients with pregnancy.
  • Patients with body temperature less than 36.5 degree Celsius or more than 38 degree Celsius.
  • Patients with local site infection.
  • Patients with spinal deformity.
  • Patients with bleeding disorder- platelet count less than 50,000/microlitre, prothrombin time more than 14 sec, International normalized ratio (INR) more than 1.5.

结局指标

主要结局

Post spinal anaesthesia shivering

时间窗: Outcome will be assessed during the intraoperative period.

次要结局

未报告次要终点

研究者

发起方
Apoorva Singh
申办方类型
Other [(Self) Post Graduate Trainee]
责任方
Principal Investigator
主要研究者

APOORVA SINGH

Regional Institute of Medical Sciences, Imphal, Manipur

研究点 (1)

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