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临床试验/CTRI/2024/02/063359
CTRI/2024/02/063359招募中不适用

Enhancing spinal anesthesia with intrathecal injection of Fentanyl as adjuvant to hyperbaric Bupivacaine. Pharmacological or physical effect? A randomized controlled clinical study

Mahatma Gandhi University of medical sciences and technology1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年9月3日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
To study the onset and duration of sensory and motor blockade, highest level of

研究概览

简要总结

After getting clearance from Institute Ethics Committee and written informed consent of eligible patients, 90 patients aged 18-60 years, American Society of Anesthesiology grade I and II scheduled for elective lower abdominal surgeries will be enrolled in this study. On arrival patients will be connected to monitor and thereafter will be randomly allocated to three groups of 30 patients each. the investigator will remain blinded to the group allocation and the drug used. Patients in group A will receive 0.5% hyperbaric Bupivacaine 3.0 ml (12.5mg) in 5.0 ml syringe. Group B will receive 0.5% hyperbaric Bupivacaine 3.0 ml in a 5.0 ml syringe followed by 0.5 ml of normal saline in 1.0 ml syringe. Group C will receive 0.5% of hyperbaric Bupivacaine 3.0 ml in 5.0 ml syringe followed by 0.5 ml (25 microgram) of Fentanyl in 1.0 ml syringe.

Subarachnoid block will be administered at L 3-4 intervertebral space in lateral decubitus position.

onset of sensory block will be assessed by sterile pin prick every 2min till 20 mins and then after every 10 mins till highest level will be achieved. Sensory onset will be defined as the loss of sensation at T10 level and motor onset when modified Bromage score turns 3. Time of regression of moto blockade will be assessed by modified Bromage score becomes 0.

Vital parameters of the patients will be assessed periodically till completion of procedure. Time till the requirement of first rescue analgesia will be recorded. Entire data would be entered into Microsoft office software, appropriate statistical test will be applied and results will be calculated.

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 and Outcome Assessor 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

  • 1.Patients scheduled for elective below umbilical surgeries under subarachnoid block.
  • 2.Patients of either sex between 18-55years of age 3.Patient under ASA CLASS I/ II 4.Patients willing to give written and informed consent.

排除标准

  • 1.Patient under ASA CLASS III, IV & V 2.HIV, HbsAg, HCV positive patients 3.Non-consenting patients.
  • 4.Patients with Local site sepsis or any contraindication for subarachnoid block.

结局指标

主要结局

To study the onset and duration of sensory and motor blockade, highest level of

时间窗: minutes

anesthesia and total duration of analgesia with bupivacaine alone or when either

时间窗: minutes

Fentanyl or saline is injected subsequent to Bupivacaine for spinal anesthesia.

时间窗: minutes

次要结局

  • 1.To study the changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), respiratory rate (RR), arterial oxygen saturation on pulse oximetry (SpO2).(2.To assess the requirement of postoperative rescue analgesia.)

研究者

发起方
Mahatma Gandhi University of medical sciences and technology
申办方类型
Private medical college

研究点 (1)

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