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临床试验/CTRI/2024/12/078050
CTRI/2024/12/078050尚未招募4 期

Comparison of effect of levobupivacaine versus Ropivacaine on Pulmonary function in patients undergoing Laparoscopic Cholecystectomy under Segmental Thoracic Spinal Anaesthesia

MDM Hospital Dr S N Medical Collage Jodhpur RAJASTHAN1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年12月22日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Comparison of pulmonary function tests, which includes measurements of the peak expiratory

研究概览

简要总结

The study will be conducted at DR S N Medical College and associated groups of hospitals after seeking clearance from the institutional ethical committee and obtaining written informed consent from the patients. To ensure inclusion in the study, each patient will be subjected to a detailed pre-anaesthetic evaluation (PAE) based on a detailed history from the patient and a thorough physical examination as well as a preanesthetic airway assessment. The purpose and detailed procedure will be explained to the patients. We will measure the weight and height of each patient to obtain the exact BMI. Written informed consent will be obtained from all the patients regarding the procedure. Baseline investigations will be done in all the patients to rule out any abnormalities. Visual analogue scale (VAS) and demonstration of the correct usage of the spirometry device to the patient will be explained to all the patients in PAE during the pre-anesthetic visit. The evening before surgery, patients will be instructed to use the spirometer to simulate testing. All patients will be kept nil by mouth as per standard guidelines before the scheduled time of surgery. In the sitting position, either of the drugs will be aseptically administered through a 25G Quincke spinal needle by a midline approach between T8-T9 / T9 T10 intervertebral space. After the free flow of cerebrospinal fluid will be verified, local anaesthetic was given over 15 seconds, without aspiration. The anesthesiologist performing the spinal anaesthesia will be not aware of group allocation. A separate independent anesthesiologist will prepare all local anaesthetic solutions. Immediately after administration of spinal anaesthesia, the patients will be turned to a supine position.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

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

入选标准

  • The patients, aged 18 to 60 years of both genders belong to ASA PS I and II undergoing elective laparoscopic cholecystectomy.

排除标准

  • Patient’s refusal Contraindications to spinal anaesthesia.

结局指标

主要结局

Comparison of pulmonary function tests, which includes measurements of the peak expiratory

时间窗: 3 Hours

flow rate (PEFR), forced vital capacity (FVC) and forced expiratory volume in first second (FEV1),

时间窗: 3 Hours

using hyperbaric levobupivacaine versus hyperbaric ropivacaine, in patients undergoing

时间窗: 3 Hours

laparoscopic cholecystectomy under segmental thoracic spinal anaesthesia.

时间窗: 3 Hours

次要结局

  • Number of cases required to be converted to GA(Perioperative hemodynamic parameters)

研究者

发起方
MDM Hospital Dr S N Medical Collage Jodhpur RAJASTHAN
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Geeta Singariya

Dr S N Medical College Jodhpur

研究点 (1)

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