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临床试验/CTRI/2025/09/094746
CTRI/2025/09/094746尚未招募不适用

A Prospective, Randomised, Parallel group study of Peri-operative blood sugar level between non-diabetic and controlled diabetic patients posted for laproscopic cholecystectomy under general anaesthesia

Midnapore medical college and hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年10月1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
30
试验地点
1
主要终点
Comparison of blood sugar levels among non-diabetic patients and controlled diabetic patients posted for laparoscopic cholecystectomy under general anaesthesia.

研究概览

简要总结

Proposed study will compare the change in the blood glucose levels of non diabetic and controlled diabetic patients undergoing laparoscopic cholecystectomy under general anesthesia . The metabolic changes patient undergoes during surgery is proportional to severity of surgical stress and trauma . Hence the monitoring of the perioperative blood sugar is crucial in managing patients undergoing general anesthesia . Along with blood sugar other parameters like -

  1. Intra operative hemodynamic changes in terms of incidence of hypertensive and hypotensive episodes

  2. Intra operative changes in heart rate, ST segment elevation up to 2 mm

  3. Wound healing up to post op 3 days

In this study currently we do not have clear idea regarding the outcome , which can only be confirmed after completion of the study

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA grade 1 non-diabetic patients with FBS less than 126, PPBS less than 200, HbA1c less than 6.5 percent
  • ASA grade 2 controlled diabetic patients on 1 or more OHA with FBS less than 126, PPBS less than 200, HbA1c less than 6.5 percent
  • BMI 18.5 to 24.9
  • Patients under oral hypoglycemic agents
  • Undergoing elective laparoscopic cholecystectomy under general anesthesia for less than 90 minutes.

排除标准

  • patients under insulin therapy.
  • patients with uncontrolled diabetes
  • patients with signs of microvascular and macrovascular complications.
  • 4.Emergency surgery.

结局指标

主要结局

Comparison of blood sugar levels among non-diabetic patients and controlled diabetic patients posted for laparoscopic cholecystectomy under general anaesthesia.

时间窗: Before induction Just after intubation 1hr after induction 1 hrs after extubation 2 hrs after extubation

次要结局

  • Both the non-diabetic & controlled diabetic groups are followed up:(1.To monitor & compare hemodynamic changes in terms of intra-operative incidence of hypertensive episode (i.e. 20% increase in baseline MAP), hypotensive episode (i.e. 20% decrease in baseline MAP) & significant ST changes if any.)

研究者

发起方
Midnapore medical college and hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Manisha Agarwal

Midnapore Medical College and Hospital

研究点 (1)

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