跳至主要内容
临床试验/CTRI/2023/12/060851
CTRI/2023/12/060851尚未招募不适用

Effect of adding ketamine to etomidate infusion on serum cortisol levels for anesthetic induction compared to etomidate infusion alone in elective surgical patients: a randomized controlled trial

Jawaharlal Institute of Postgraduate Medical Education and Research1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年1月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
To compare the changes in the serum cortisol levels after giving the allotted drugs (Etomidate or Etomidate and Ketamine)

研究概览

简要总结

The purpose of this study is to compare the effect of twodifferent anaesthetic regimen (Etomidate alone or Etomidate with Ketamine) thatwill be used to induce loss of consciousness in patients (in order to alleviatethe pain and agony during surgery) on the alteration of Serum Cortisol levels.2. Procedure/methods of the study. Cortisol is an hormone which is an essentialregulator of carbohydrate, protein and lipid metabolism, which is essential fornormal functioning of humans. In this study the patients will be alloted intoeither of the two groups (Group E and Group KE) with equal possibilities ofgetting into either of the group and both of these regimen can result in thedesired effect of loss of consciousness in patients while you undergo thesurgery. On reaching the operation theatre patients will be secured intravenouscannula which is the routine practice to administer drugs and fluids while youundergo surgery and two ml of blood will be taken for calculating baselinecortisol values. Vitals such as heart rate and blood pressure will be measuredevery 2 minutes . After this, patient will be administered with eitherEtomidate only or Ketamine and Etomidate depending upon the random group inwhich the patient is allotted (Group K or KE). Patient breathing will beassisted by an anaesthesiologist after they attain loss of consciousness. Once thepatient is completely anesthetized by the allocated anesthetic drug endotrachealtube will be inserted to maintain respiration during surgery. Patients bloodpressure and heart rate will be monitored at 1st ,3rd ,5th and 10th minute fromthe time of loss of consciousness. .Once this is done, the pateint will bemanaged as per the attending Anaesthesiologist and he/she will be instructednot to administer steroids during or upto 24 hours. Similar to before the surgery,3 more blood samples at 4, 12 and 24 hours after loss of consciousness will betaken to estimate the change in serum cortisol levels after administration ofthe allocated anesthetized drug. The suppression in serum cortisol level betweenthe intervention and the control arm will be compared by the samples takenbefore induction and at 4 hours,12 hours and 24 hours.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
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 aged 18-60 years posted for elective surgeries undergoing general anaesthesia 2)ASA class 1 & 2.

排除标准

  • Pregnant and lactating women 2)Patients belonging to NYHA class 3&4 3)Known case of adrenal insufficiency 4)Known case of seizure disorder 5)Patients on steroid therapy 6)Patients who may require intraoperative or postoperative steroids.

结局指标

主要结局

To compare the changes in the serum cortisol levels after giving the allotted drugs (Etomidate or Etomidate and Ketamine)

时间窗: To compare the changes in the serum cortisol levels at baseline and after giving the allotted drugs (Etomidate or Etomidate and Ketamine) at 4hrs, 12hrs, and 24hrs.

次要结局

  • The time required for serum cortisol level to return to pre-induction range(The time required for serum cortisol level to return to pre-induction range by comparing the serum cortisol level measured at baseline,4hrs, 12hrs & 24hrs post induction)
  • To compare the reduction in the etomidate dose requirement during induction of anesthesia between the two groups (Etomidate or Etomidate & Ketamine)(To compare the reduction in the etomidate dose requirement during induction of anesthesia between the two groups (Etomidate or Etomidate & Ketamine) which is measured at the time of induction)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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