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临床试验/CTRI/2024/11/076695
CTRI/2024/11/076695已完成不适用

A COMPARATIVE STUDY BETWEEN INTRA-THECAL HYPERBARIC BUPIVACAINE 0.5% 3.0 cc WITH NALBUPHINE 0.4 MILLIGRAM VERSUS HYPERBARIC BUPIVACAINE 0.5% 3.0 CC WITH FENTANYL 25 MICROGRAM IN INFRAUMBILICAL SURGERIES

Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月19日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Aim of this study is to compare the efficacy of Fentanyl and nalbuphine used as additive to bupivacaine in subarachnoid block to compare hemodynamic response in infraumbilical surgeries

研究概览

简要总结

THE PURPOSE OF THE STUDY IS TO COMPARE THE HEMODYNAMIC VARIABLE AND POST-OPERATIVE ANAGLESIA IN PATIENTS RECEIVING INTRA-THECAL NALBUPHINE AND FENTANYL AS AN ADDITIVE TO HYPERBARIC BUPIVACAINE IN BELOW UMBILICAL SURGRIES.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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

  • Patients willing to sign the informed written consent. Patients of ASA Grade I and II of either gender. Under Spinal anaesthesia for elective BELOW UMBILICAL SURGERIES Aged
  • 60 years. No known history of allergy, sensitivity to local anaesthetics of the amide group and other drugs used for this study.

排除标准

  • Patient refusal.
  • Patient not NIL by mouth.
  • History of seizure disorder.
  • Known allergy to trial drugs.
  • Patients with neurological disorders and neuropathies or receiving medications known to influence neuromuscular junction.
  • ASA III, IV, V Patients.
  • Patient with prior pre-existing Comorbidities (Heart diseases, Respiratory disease, Kidney diseases , known fetal abnormalities) Pregnant females Failed spinal anaesthesia converted to general anaesthesia Any contraindication to Spinal Anaesthesia (local site infection, spine deformity, clotting abnormalities.
  • Patients fulfilling above inclusion criteria are taken for study.

结局指标

主要结局

Aim of this study is to compare the efficacy of Fentanyl and nalbuphine used as additive to bupivacaine in subarachnoid block to compare hemodynamic response in infraumbilical surgeries

时间窗: baseline | 0 Minute | 2 Minutes | 5 Minutes | 10 Minutes | 20 Minutes | 30 Minutes | 45 Minutes | 60 Minutes | 75 Minutes | 90 Minutes | 120 Minutes | 150 Minutes | 180 Minutes

次要结局

  • to compare duration of Post-operative analgesia in group fentanyl and group nalbuphine(post operative rescue anaglesia)

研究者

发起方
Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Kartik H Sangam

Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre

研究点 (1)

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