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临床试验/CTRI/2024/10/075564
CTRI/2024/10/075564尚未招募不适用

Effect on sensory block duration after spinal anesthesia supplemented with intravenous Dexamethasone.

Dibyanshu Shekhar Swain1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Sensory block duration

研究概览

简要总结

The randomised, doubleblind interventional study will be conducted in the Department of Anaesthesiology at AIIMS,Raipur. After obtaining approval from Institutional Ethics Committee, this study will beconducted for 18 months in 60 American Society of Anaesthesiologists(ASA) physical status I and II patients in the age group of 18–60 years posted for elective unilateral open inguinal hernia surgeries. Patients with a history of allergy to drugs used in the study, a history of substance abuse, with a body mass index (BMI) ≥35 and patients with psychosis/gross neurological disorders will be excluded. All the patients who meet the inclusion criteria will be enrolled in the study and written informed consent will be obtained for the participation in the study

All patients will be made to fast according to the standard nil per oral guidelines. The patients will be randomised into two groups by a computergenerated randomisation list to receive either of the two regimens. [Figure 1] For the BD group, 3 ml of 0.5% bupivacaine(heavy) with 8 mg of dexamethasone(2ml)IV and for the BS group 3 ml of 0.5% bupivacaine(heavy) with 2ml normal saline IV was administered to keep the total volume the same in both groups.

A doubleblinding technique will be followed, where an anaesthesiologist who is not part of the study will prepare the solution according to the allocated group. The solution will then be handed over to the investigator who will administer the spinal anaesthesia. The investigator will be unaware of the group allocation.

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 60.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anaesthesiologists (ASA) physical status I and II patients in the age group of 18–60 years posted for elective unilateral open inguinal hernia surgeries.

排除标准

  • Patients with a history of allergy to drugs used in the study, a history of substance abuse, with a body mass index (BMI) ≥35 and patients with psychosis/gross neurological disorders will be excluded.

结局指标

主要结局

Sensory block duration

时间窗: Intra-operative period

次要结局

  • 1) To determine the time taken to achieve highest level of sensory block.(2) To determine Time required to first rescue analgesia.)

研究者

发起方
Dibyanshu Shekhar Swain
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dibyanshu Shekhar Swain

AIIMS Raipur

研究点 (1)

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