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临床试验/CTRI/2024/06/068959
CTRI/2024/06/068959尚未招募4 期

Intrathecal fentanyl with hyperbaric levobupivacaine 0.5% in fractionated versus sequential dose spinal anaesthesia: Randomized controlled trial

Rohilkhand Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年7月1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
70
试验地点
1
主要终点
1. Onset of sensory & motor blockade

研究概览

简要总结

Spinal anesthesia has significantly evolved, offering various techniques and adjuvants to enhance efficacy and patient outcomes. Notably, the combination of intrathecal fentanyl with hyperbaric levobupivacaine is of great interest. This study compares the efficacy of this combination when administered through Sequential Spinal Anesthesia (SSA) and Fractionated Spinal Anesthesia (FSA).

Hyperbaric levobupivacaine, a long-acting local anesthetic with reduced cardiovascular toxicity, is favored in spinal anesthesia. When combined with fentanyl, known for its rapid onset and analgesic properties, it potentially enhances spinal anesthesia quality by providing optimal intraoperative conditions and extended postoperative analgesia.

FSA, an innovative technique to mitigate hypotension, administers the local anesthetic in fractions with short intervals, aiming for a more controlled block with fewer hemodynamic issues. However, concerns about complications like post-dural puncture headache and neurological deficits limit its use.

In contrast, SSA involves sequential administration of anesthesia components, each tailored to exploit specific benefits, offering an alternative to FSA’s challenges. The baricity of the fentanyl and hyperbaric levobupivacaine mixture can affect local anesthetic spread in cerebrospinal fluid (CSF), impacting anesthesia efficacy.

Research indicates that mixing adjuvants with hyperbaric bupivacaine can alter CSF distribution, whereas administering them separately might avoid these changes, improving onset, duration, and hemodynamic stability.

The study evaluates FSA versus SSA by examining sensory and motor blockade onset and duration, intraoperative conditions, and hemodynamic stability. This research aims to fill gaps in existing literature and enhance spinal anesthesia practices, aiding practitioners in providing better patient care.

This study seeks to critically examine and compare the efficacy of intrathecal fentanyl with hyperbaric levobupivacaine 0.5% when administered through two different dosing strategies fractionated spinal anaesthesia and sequential spinal anaesthesia. Key parameters under scrutiny include the onset and duration of sensory and motor blockade, intraoperative conditions, and hemodynamic stability. This research endeavours to contribute nuanced insights into refining spinal anesthesia administration techniques, ultimately aiming for enhanced patient safety, comfort, and positive perioperative experiences.

By shedding light on the comparative merits of Sequential and Fractionated Spinal Anesthesia, this investigation aspires to guide anaesthetic practitioners in making informed decisions, advancing the standards of spinal anesthesia practice for improved patient care.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • American society of Anaesthesiologist (ASA) grade I or II
  • Patient undergoing elective infra umbilical surgeries.

排除标准

  • Patient refusal for the procedure
  • Infection at the site
  • Any abnormality of spine
  • Allergy to local anaesthetics
  • Coagulopathy.

结局指标

主要结局

1. Onset of sensory & motor blockade

时间窗: Sensory block will be assessed after 1 minute of injection every 1min until the level is established for four consecutive tests, after that assessment will continue every 10 min until 2 segment regression occurs. The time for motor block from bromage 3 to bromage 2 will be considered as the duration of motor blockade.

2. Highest level of sensory block

时间窗: Sensory block will be assessed after 1 minute of injection every 1min until the level is established for four consecutive tests, after that assessment will continue every 10 min until 2 segment regression occurs. The time for motor block from bromage 3 to bromage 2 will be considered as the duration of motor blockade.

3. Time for two segment regression of sensory block

时间窗: Sensory block will be assessed after 1 minute of injection every 1min until the level is established for four consecutive tests, after that assessment will continue every 10 min until 2 segment regression occurs. The time for motor block from bromage 3 to bromage 2 will be considered as the duration of motor blockade.

4. Duration of motor blockade

时间窗: Sensory block will be assessed after 1 minute of injection every 1min until the level is established for four consecutive tests, after that assessment will continue every 10 min until 2 segment regression occurs. The time for motor block from bromage 3 to bromage 2 will be considered as the duration of motor blockade.

5. Time for first rescue analgesic

时间窗: Sensory block will be assessed after 1 minute of injection every 1min until the level is established for four consecutive tests, after that assessment will continue every 10 min until 2 segment regression occurs. The time for motor block from bromage 3 to bromage 2 will be considered as the duration of motor blockade.

6. Incidence of post-operative nausea, vomiting and post spinal shivering.

时间窗: Sensory block will be assessed after 1 minute of injection every 1min until the level is established for four consecutive tests, after that assessment will continue every 10 min until 2 segment regression occurs. The time for motor block from bromage 3 to bromage 2 will be considered as the duration of motor blockade.

次要结局

  • Hemodynamic parameters (Heart rate, systolic and diastolic blood pressure, mean arterial pressure)(During the surgery the patient’s heart rate, Systolic and Diastolic blood pressure, Mean Arterial Pressure, arterial oxygen saturation will be recorded every 5 mins for 30 minutes and then every 10 minutes until completion of the surgery.)

研究者

发起方
Rohilkhand Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Neeharika Arora

Rohilkhand Medical College and Hospital

研究点 (1)

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