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临床试验/CTRI/2024/10/075923
CTRI/2024/10/075923尚未招募不适用

Effect of induction of general anaesthesia with etomidate, propofol and thiopentone on serum cortisol and blood sugars in diabetic patients undergoing open gastrointestinal surgery – A randomized controlled study.

Dr Indira Gurajala1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年11月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
to compare S. cortisol levels at 4 hours after etomidate/thiopentone/propofol induction in diabetic patients and etomidate induction in non diabetic patients respectively

研究概览

简要总结

This prospective randomised study will include 40 patients  posted for elective open  gastrointestinal surgeries under combined general epidural anaesthesia of both gender aged 18 to 70 years with diabetes   after obtaining Institute Ethics approval ,CTRI registration and paients written informed consent.Exclusion criteria will include  Hepato- biliary and pancreatic surgeries , patients receiving steroids, beta blockers, renal, hepatic disease, prgnant, lactating women.  Premedication will be with tablet raniditidine and alprozolam and fasted for 6 hours before surgery.  Intraop ASA Monitors will be connected. Epidural catheter  will be secured at T8-10 intervertebral disc space . Premedication with fentanyl followed  by induction with etomidate/thiopentone/propofol as pwer randomisation (. Later oral intubation with rocuronium muscle relaxant. Arterial cannula in radial artery will be secured  Intraop maintance will be  air:O2 (1:1) ,atracurium, fentanyl, sevoflurane . After surgery completion, parient will be extubated and shifted to postop area.  Parameters to be measured will be Serum cortisol  baseline, 4 and 24 hours after induction, blood sugars  at baseline, postinduction 4, 12 and 24 hours

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 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Diabetic patients of either gender aged 18 to 70 years undergoing elective open gastrointestinal surgery with duration 4-8 hours under combined general and epidural anaesthesia will be included as test groups (PD, TD, ED) .
  • Non-diabetic patients of either gender aged 18 to 70 years undergoing elective open gastrointestinal surgery with duration 4-8 hours under combined general and epidural anaesthesia will be included as control group (EC).
  • preoperative HbA1C of less than 8 %.

排除标准

  • 1.hepato- biliary and pancreatic surgeries
  • other concomitant endocrine disorders,
  • receiving preop/intraop steroids and beta-blockers, 4.renal or hepatic disease and 5.Pregnant or lactating women 6.intraoperative Blood loss more than 500 ml
  • surgeries more than 8 hours duration.

结局指标

主要结局

to compare S. cortisol levels at 4 hours after etomidate/thiopentone/propofol induction in diabetic patients and etomidate induction in non diabetic patients respectively

时间窗: at 4 hours after induction

次要结局

  • 1..to compare S. cortisol levels at 24 hours after etomidate/thiopentone/ propofol induction in diabetic patients and etomidate induction in non-diabetic patients respectively

研究者

发起方
Dr Indira Gurajala
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Indira Gurajala

Nizams Institute of Medical Sciences Hyyderabad: Pincode: 500082

研究点 (1)

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