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临床试验/CTRI/2025/10/096229
CTRI/2025/10/096229尚未招募3 期

Comparison of segmental thoracic spinal anaesthesia and general anaesthesia in umbilical and supraumbilical hernia surgeries

Peoples Hospital Bhopal1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年11月1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
70
试验地点
1
主要终点
To Observe Hemodynamic Parameters And Post-Operative Recovery In Patients Undergoing Segmental Thoracic Spinal Anaesthesia And General Anaesthesia and To Compare Between The Observations Of The Two Groups

研究概览

简要总结

Patients will be divided into 2 groups, Group S receiving Segmental Thoracic Spinal Anaesthesia and Group G receiving General Anaesthesia.

In Group S, the patients posted for elective umbilical and supraumbilical hernia surgeries, STSA will be given by a 25G Quincke’s Needle at T10 level with Injection 0.5% Isobaric Levobupicavaine 6.25 mg (1.25ml) with Injection Fentanyl 25 mcg administered at a speed of 0.2 ml/second. Sensory effect will be measured by pin prick method.

In Group G, the patients posted for both elective umbilical and supraumbilical hernia surgeries, after pre oxygenation with 100% oxygen for 3 minutes, injection Glycopyrrolate 2-4 mcg/kg, Injection Ondansetron 0.2 mg/kg, Injection Midazolam 0.1-0.2 mg/kg, Injection Fentanyl 1-2 mcg/kg, patients will be induced with Injection Propofol 2 mg/kg and Injection Atracurium 0.5-0.6 mg/kg. Anaesthesia will be maintained with Oxygen, Nitrous Oxide, Isoflurane and injection Atracurium 0.1mg/kg and Paracetamol 1 gm intravenously as required. After the completion of the said surgery, patients will be reversed with Injection Glycopyrrolate 0.01 mg/kg and Injection Neostigmine 0.05 mg/kg and extubated.

The hemodynamic parameters will be noted down at the time of injection (0 minutes), at 2 minutes, at 5 minutes, 10 minutes, 15 minutes, 30 minutes and 1 hour, 2 hour, 4 hour, 6 hour. VAS Scoring will be done postoperatively at 1 hour, 2 hour,4 hours, and 6 hours respectively. Time required opr rescue analgesia will be noted in both the groups. Perioperative complication will be noted and managed if any.

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 65.00 Year(s)(—)
性别
All

入选标准

  • ASA Grade I & II Patients Scheduled For Elective Umbilical And Supraumbilical Hernia Surgeries.

排除标准

  • Patient Refusal Age Less Than 18 Years And More Than 65 Years ASA Grade III Or More BMI More Than 35 Kg Per m2 Patients With Uncorrected Hypovolemia Or Shock Patients With Raised Intracranial Pressure Patients With Abnormal Coagulation Profile Patients With Hypersensitivity To Any Of The Drugs Used Pregnant And Lactating Mother.

结局指标

主要结局

To Observe Hemodynamic Parameters And Post-Operative Recovery In Patients Undergoing Segmental Thoracic Spinal Anaesthesia And General Anaesthesia and To Compare Between The Observations Of The Two Groups

时间窗: Upto 6 hours

次要结局

  • To compare the time needed for rescue analgesia in the two groups(Upto 6 hours)

研究者

发起方
Peoples Hospital Bhopal
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Rajvardhan Singh

Peoples College of Medical Sciences and Research Centre Bhopal

研究点 (1)

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