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临床试验/CTRI/2025/01/079600
CTRI/2025/01/079600已完成不适用

A COMPARATIVE STUDY BETWEEN INTRATHECAL HYPERBARIC BUPIVACAINE 0.5 percent 3.0cc WITH NALBUPHINE 0.4 MILLIGRAM VERSUS HYPERBARIC BUPIVACAINE 0.5 percent 3.0 CC WITH FETANYL 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 60 人开始时间: 2025年2月2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
60
试验地点
1
主要终点
This study aims to compare the efficacy of Fentanyl and nalbuphine used as an additive to bupivacaine in subarachnoid block to compare the hemodynamic response in infra-umbilical 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.

AIM:

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

Objectives:

TO COMPARE ONSET OF SENSORY AND MOTOR BLOCKADE

TO COMPARE DURATION OF SENSORY AND MOTOR BLOCKADE

COMPARE SEDATION OF PATIENT

TO COMPARE THE HAEMODYNAMIC CHANGES IN (PULSE RATE, BLOOD PRESSURE, OXYGEN SATURATION AND RESPIRATORY RATE)

TO COMPARE DURATION OF ABSOLUTE ANALGESIA AND EFFECTIVE ANALGESIA

TO COMPARE THE REQUIREMENT OF NUMBER OF RESCUE ANALGESIA

TO COMPARE THE SIDE EFFECTS/COMPLICATIONS IF any

Inclusion Criteria:

● Patients willing to sign the informed written consent.

● Patients of ASA Grade I and II of either gender.

● Under Spinal anaesthesia for elective lower limb surgeries

● Aged 18 - 60 years.

● No known history of allergy, sensitivity to local anaesthetics of the amide group and other drugs used for this study.

Exclusion Criteria:

‘● 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.

Method

After obtaining written informed consent, 60 patients planned for elective surgeries will be enrolled and grouped into Group-F  & Group-N with 30 patients in each group.

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 Blinded

入排标准

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

入选标准

  • Patients are 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 Age
  • 60 years. No known history of allergy or 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.
  • Patients with prior pre-existing Comorbidities (Heart diseases, Respiratory diseases, 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 the above inclusion criteria are taken for study.

结局指标

主要结局

This study aims to compare the efficacy of Fentanyl and nalbuphine used as an additive to bupivacaine in subarachnoid block to compare the hemodynamic response in infra-umbilical surgeries

时间窗: Hemodynamic response and Onset of Sensory and motor blockade asseses at | Baseline | 2min | 5 mins | 10 mins | 15 mins | 20 mins | 30 mins | 45 mins | 60 mins | 90 mins | 120 mins

次要结局

  • to compare duration of Post-operative analgesia in group fentanyl & group nalbuphine(Post-operative 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

Dr Kartik H Sangam

Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre

研究点 (1)

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