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临床试验/NCT07751835
NCT07751835尚未招募1 期

Comparison of Incidence of Hemodynamics and Block Characteristics Between Height Based Versus Conventional Fixed Dose Spinal Anesthesia in Lower Limb Surgeries: a Randomized Controlled Trial

Liaquat National Hospital & Medical College0 个研究点目标入组 104 人开始时间: 2026年8月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
尚未招募
入组人数
104
主要终点
Hypotension and Bradycardia

研究概览

简要总结

This study aim is to compare height based dose of spinal anesthesia vs conventional dose. Hypothesis is height based dose has less hemodynamics changes compared to conventional dosing.

详细描述

This is a prospective, randomized, double blinded, controlled trial with minimum 6 months of data collection. Patients will be divided into two groups randomly. Group H and C each having 52 patients. Groups H will be given spinal anesthesia dose according to their height by pre determined dosing algorithm. Group C will be given a fixed dose of Hyperbaric Bupivacaine 0.5% 12.5mg (2.5ml) without adjusting it according to their height. Pateint's blood pressure and Heart rate along with sensory effect will be recorded 5,10 and 15 minutes later after spinal anesthesia. I will be recording any episode of bradycardia and hypotension and intervention needed to treat it in both the groups

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • both genders. 18-65 years age ASA physical status I and II

排除标准

  • ASA III and IV Refusal of patient Height less than 150 cm Known allergy to study drug

研究组 & 干预措施

height based spinal anesthesia dose

Active Comparator

Height based dose

干预措施: Height based dose of hyperbaric bupivacaine 0.5% (Drug)

Conventional dose of spinal anesthesia

Active Comparator

Conventional dose of hyperbaric bupivacaine 0.5%

干预措施: Height based dose of hyperbaric bupivacaine 0.5% (Drug)

结局指标

主要结局

Hypotension and Bradycardia

时间窗: 6 months

Icidence of hypotension and bradycardia

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zuniara Siddqui

Principal investigator

Liaquat National Hospital & Medical College

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