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临床试验/CTRI/2026/01/101571
CTRI/2026/01/101571尚未招募不适用

Incidence of conversion to general anesthesia and need for intravenous supplementation in patients undergoing gynecologic laparoscopic procedures under spinal anesthesia: an observational study

Dr Swati Ganesh Pai1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2026年1月30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
180
试验地点
1
主要终点
To assess the incidence of conversion from Spinal anaesthesia to GA in gynaecologic laparoscopic surgeries when spinal anaesthesia is provided.

研究概览

简要总结

Laparoscopic procedures, increasingly used in gynaecology, have traditionally been performed under general anaesthesia (GA). However, with the growth of day-care surgeries, spinal anaesthesia (SA) is being used more widely due to advantages such as rapid recovery, reduced postoperative pain, minimal respiratory compromise, and better haemodynamic stability. Despite these benefits, SA may be associated with complications including shoulder pain, inadequate analgesia, nausea, vomiting, and hypotension. Failed or inadequate spinal blocks may lead to intraoperative intravenous supplementation or conversion to GA, which carries a higher risk of complications compared to either technique alone.

This prospective observational study aims to determine the incidence and reasons for conversion from SA to GA in elective gynaecological laparoscopic surgeries. A total of 180 ASA I–II female patients aged 18–60 years undergoing procedures at KIMS, Hubli will be evaluated. Standard preoperative preparation and spinal anaesthesia with 0.5% hyperbaric bupivacaine will be administered. Intraoperative parameters, requirement for intravenous supplementation, timing of drug administration, complications, and factors such as anaesthesiologist and surgeon experience will be recorded. Data will be analysed using appropriate statistical tests and multivariable regression to identify predictors of conversion. The study aims to improve understanding of SA reliability and factors influencing its failure in gynaecologic laparoscopy.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • ASA physical status class 1 and 2 posted for gynaecological laparoscopic procedures under spinal anaesthesia.

排除标准

  • refusal to spinal anaesthesia ASA physical status class 3 and 4 allergic to local anaesthetics coagulation disorders infection at lumbar puncture site.

结局指标

主要结局

To assess the incidence of conversion from Spinal anaesthesia to GA in gynaecologic laparoscopic surgeries when spinal anaesthesia is provided.

时间窗: assess when the patient complains of pain or discomfort and a need to convert to general anaesthesia and iv supplementaion in needed

次要结局

  • To estimate the rate of intraoperative intravenous supplementation, drugs administered and the time of administration.(noted when case converted to general anaesthesia or iv supplementation in given)

研究者

发起方
Dr Swati Ganesh Pai
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Swati Ganesh Pai

Karnataka Institute of Medical Sciences

研究点 (1)

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