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临床试验/CTRI/2024/03/064794
CTRI/2024/03/064794尚未招募Unknown

A COMPARATIVE STUDY OF INTRATHECAL DEXMEDETOMIDINE VERSUS CLONIDINE AS ADJUVANT TO 0.75% HYPERBARIC ROPIVACAINE IN INFRA UMBILICAL SURGERIES :A RANDOMISED CLINICAL TRIAL

Dr Soumya Patted1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年4月6日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
1) To compare the block characteristics of intrathecal Dexmedetomidine versus Clonidine as an adjuvant to 0.75% Hyperbaric Ropivacaine in terms of the onset and duration of sensory block and motor block

研究概览

简要总结

70 patients will be randomly grouped by computer generated numbers and assigned to one of the two groups:

Group RD (n=35) will receive 0 .75% hyperbaric Ropivacaine 3 ml + Dexmedetomidine 5 mcg

Group RC (n=35) will receive 0 .75% hyperbaric Ropivacaine 3 ml + Clonidine 50 mcg intrathecally.

Data will be collected in the case record proforma meeting the objectives of the study. Pre anaesthetic evaluation will be done for each patient and written informed consent will be taken. All patients will be fasted 8 hours for solid food and 4 hours for clear fluids. Intravenous line will be obtained with 18-gauge cannula and will be preloaded with Ringer lactate at 15 ml/kg body weight about 20 minutes before anaesthesia. Patients will be monitored with pulse oximetry( spO2), electrocardiography (ECG), non- invasive blood pressure (NIBP).Under aseptic precautions lumbar puncture will be performed at the level of L3- L4 intervertebral space through a midline approach using 25 G Quincke’s spinal needle and study drug will be injected after confirmation of needle tip in the subarachnoid space by clear and free flow of cerebrospinal fluid.

Patients will be randomly divided into 2 groups by computer generated random sequence table (www.randomization.com)namely Group RD and Group RC in a sealed envelope with labelled syringe. Drug will be given by anaesthetist not involved in study.Intrathecal injection will be given over approximately 10-15seconds. Patients wil be made to lie in supine position immediately. All the things will be kept ready for general anesthesia if needed. Table will be kept in neutral position. All the patients wil be given oxygen by Hudson mask at 6 Litres/minute. The time of intrathecal injection will be noted and taken as 0 minute.

Patients will be monitored with ECG ,NIBP ,SPO2 and respiratory rate at regular intervals of every 5 minutes and continued in the post-operative period.When Visual Analogue Scale(VAS)of >4 or when patient desires rescue analgesic (Paracetamol)will be given

Sensory blockade will be tested using pin prick method with a blunt 27 Gauge hypodermic needle along midclavicular line bilaterally every 30 seconds till the loss of sensation at T10 dermatomal level and thereafter at 2 mins intervals till the maximum level of sensory blockade is achieved and subsequently at 30 mins interval until complete recovery.

Motor block will be assessed by using a Modified Bromage Scale every 1 minute for the first 5 min, then at 5-min intervals for next 30 minutes and at every 30 minutes intervals until complete resolution of motor  block.Parameters assessed will be BP, HR, SpO2, RR , onset ,duration and maximum level of sensory and motor block , duration of analgesia and sedation, rescue analgesic requirement. All these parameters will beonitered both intra  and postoperative period

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator 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

  • Patients of age group 18-60 years undergoing infraumbilical surgeries under supbarchnoid block.
  • Patients willing to give written informed consent
  • Patients belonging to ASA I and II.

排除标准

  • 未提供

结局指标

主要结局

1) To compare the block characteristics of intrathecal Dexmedetomidine versus Clonidine as an adjuvant to 0.75% Hyperbaric Ropivacaine in terms of the onset and duration of sensory block and motor block

时间窗: From time of intrathecal injection to every 30 seconds till the loss of sensation at T10 dermatomal level and thereafter at 2 mins intervals till the maximum level of sensory blockade is achieved and subsequently at 30 mins interval until complete recovery. | From time of intrathecal injection every 1 minute for the first 5 min, then at 5-min intervals for next 30 minutes and at every 30 minutes intervals until complete resolution of motor anesthesia.

2) To compare the duration of post operative analgesia

时间窗: From time of intrathecal injection to every 30 seconds till the loss of sensation at T10 dermatomal level and thereafter at 2 mins intervals till the maximum level of sensory blockade is achieved and subsequently at 30 mins interval until complete recovery. | From time of intrathecal injection every 1 minute for the first 5 min, then at 5-min intervals for next 30 minutes and at every 30 minutes intervals until complete resolution of motor anesthesia.

次要结局

  • to compare effects of dexmedetomidine and clonidine on hemodynamic parameters, sedation and adverse effects.

研究者

发起方
Dr Soumya Patted
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Soumya Patted

Bangalore Medical College and Research Institute, RGUHS University, Karnataka

研究点 (1)

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