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临床试验/CTRI/2025/07/090507
CTRI/2025/07/090507尚未招募不适用

Study to compare changes in blood glucose levels in patients undergoing infraumbilical surgeries under spinal versus general anaesthesia

Varun N S1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年7月22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
72
试验地点
1
主要终点
Perioperative capillary blood glucose levels

研究概览

简要总结

After obtaining ethical committee clearance, patients aged 18-60 years belonging to ASA class I and II undergoing elective infraumbilical surgeries under either spinal anaesthesia or general anaesthesia fulfilling the pre determined inclusion and exclusion  criteria will be enrolled in the study. The data shall be recorded using a semi structured proforma which contains 2 parts.

1.     The first part contains the details regarding socio-demographic characteristics like name, age, sex and baseline values of Pulse rate, Systolic and Diastolic  Blood pressure, Mean Arterial Pressure and SpO2 will be recorded.

2.     The second part contains the details of time of induction of spinal anaesthesia/general anaesthesia and the capillary blood glucose levels just before induction.

GA group: Patients undergoing infraumbilical surgeries under general anaesthesia as follows: pre-oxygenation with 100% oxygen, induction with 2mg/kg of propofol, 2mcg/kg of Fentanyl, and 2mg/kg vecuronium for tracheal intubation, maintaining anaesthesia with oxygen, nitrous oxide, sevoflurane, and vecuronium. At the end of the surgery, patients will be reversed with glycopyrolate and neostigmine followed by tracheal extubation.

SA group: Patients undergoing infraumbilical surgeries under spinal anaesthesia receiving 0.5% heavy bupivacaine 15mg in L3-L4 interspace using 25G Quincke’s needle and in whom sensory block was achieved to T6 dermatomal level.

Patients will be administered with adequate intravenous crystalloid fluids like normal saline as a part of routine intraoperative management.

Capillary blood glucose levels (CBG) will be noted four times through out the perioperative period.

Time 1 (T1): preoperatively 5 mins before induction of anaesthesia as a baseline value

Time 2 (T2): intraoperatively 30 mins after induction of anaesthesia.

Time 3 (T3): immediately at the end of surgery in both the groups.

Time 4 (T4): postoperatively 60 mins after the end of surgery in the recovery room. During each time sample taking, the tips of fingers of the non dominant hand were disinfected with an alcohol swab before pricking with a lancet to measure capillary blood glucose levels

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • ASA I and II patients.

排除标准

  • 未提供

结局指标

主要结局

Perioperative capillary blood glucose levels

时间窗: 3 months

次要结局

未报告次要终点

研究者

发起方
Varun N S
申办方类型
Other [Post Graduate student]
责任方
Principal Investigator
主要研究者

SANTHOSH M C B

Mandya Institute of Medical Sciences

研究点 (1)

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