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临床试验/CTRI/2024/12/077813
CTRI/2024/12/077813尚未招募4 期

Comparative evaluation of the efficacy and safety of INTRATHECAL 0.5% hyperbaric Levobupivacaine with 0.5% hyperbaric Bupivacaine in patients undergoing LSCS under spinal anesthesia

pacific medical college and hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12月16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
60
试验地点
1
主要终点
0.5% hyperbaric Levobupivacaine is better in efficacy and safety in comparison to 0.5% hyperbaric Bupivacaine in LSCS under spinal anesthesia.

研究概览

简要总结

After obtaining approval from hospital ethical committee and written informed consent, patients will be divided into two groups randomly. All patients will be assessed before surgery for anesthesia fitness. Patients will be prepared by fasting (8 h for solid foods, 4 hours for clear fluids). On arrival to the operating room, ASA standard monitoring will be applied to all patients, including pulse oximeter, electrocardiogram and noninvasive arterial blood pressure. An 18/20 -gauge intravenous catheter will be placed and 10ml/kg lactated Ringer solution as preloading before spinal Anesthesia will be given to all patients, Under all aseptic precautions subarachnoid block will be performed at L3-L4 interspace with patient in sitting position, using either 2.2ml of 0.5% hyperbaric Levobupivacaine (Group L) or 2.2 ml of 0.5% hyperbaric Bupivacaine (Group B). After spinal block, patients will be placed in supine position and oxygen will be provided via a facemask. Sensory and motor block will be assessed by an anesthesiologist. The segmental level of sensory block will be assessed by loss of sensation to pin-prick.

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 35.00 Year(s)(—)
性别
Female

入选标准

  • 1.Informed Consent.
  • 2.Pregnant females scheduled to undergo lower segment caesarean section (LSCS) under spinal anesthesia.
  • 3.American Society of Anesthesiologists (ASA) grade I & II.
  • 4.Age 18-35 years.

排除标准

  • 1.Refusal to give consent.
  • 2.Emergency LSCS.
  • 3.Drug allergy to local anaesthetics / study drugs.
  • 4.ASA grade III and above.
  • 5.AGE less than 18 years or more than 35years.
  • 6.Weight less than 50 Kgs or more than 90Kgs.
  • 7.Height less than 5 feet.
  • 8.Twin /Complicated pregnancy.

结局指标

主要结局

0.5% hyperbaric Levobupivacaine is better in efficacy and safety in comparison to 0.5% hyperbaric Bupivacaine in LSCS under spinal anesthesia.

时间窗: 24 months

次要结局

  • Is 0.5% hyperbaric Levobupivacaine better in terms of efficacy and safety profile with routinely used drug 0.5% hyperbaric bupivacaine in spinal anesthesia.

研究者

发起方
pacific medical college and hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Ashish Kumar Sharma

Pacific Medical College and Hospital Udaipur

研究点 (1)

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