跳至主要内容
临床试验/CTRI/2024/12/077858
CTRI/2024/12/077858尚未招募不适用

A prospective randomized double blind study to compare effect of subcutaneous dexmedetomidine versus clonidine as an adjuvant to spinal anaesthesia in patients undergoing lower abdominal surgeries

JLN medical college and hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12月20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
duration of analgesia

研究概览

简要总结

The research proposal is titled, "A Prospective Randomized Double-Blind Study to Compare Effect of Subcutaneous Dexmedetomidine Versus Clonidine as an Adjuvant to Spinal Anaesthesia in Patients Undergoing Lower Abdominal Surgeries."

Key Aspects of the Dissertation Plan:

Objective: The primary objective is to compare the duration of postoperative analgesia when using subcutaneous dexmedetomidine versus clonidine as adjuvants to bupivacaine spinal anesthesia in patients undergoing lower abdominal surgeries. Secondary objectives include comparing onset and duration of sensory and motor block, intraoperative hemodynamic variability, postoperative Visual Analog Scale (VAS) score, Ramsay Sedation Scale, total analgesia requirement in 24 hours, and adverse effects.

Methodology: This will be a prospective, randomized, double-blind, comparative study involving 60 patients (30 in each group: dexmedetomidine, clonidine, and placebo).  The study will be conducted at Jawaharlal Nehru Hospital and attached hospitals in Ajmer, India.  Subcutaneous administration of the drugs will be used.  Data analysis will be performed using SPSS software.

Ethical Considerations: The plan includes obtaining informed consent from patients or their guardians and approval from the college’s ethical committee. The rationale for the subcutaneous route is justified based on its advantages of similar efficacy to IV administration, with less hemodynamic instability and a prolonged effect.

Drugs Used: Hyperbaric bupivacaine (0.5%), dexmedetomidine (0.5 mcg/kg), and clonidine (1 mcg/kg) will be administered subcutaneously after subarachnoid block with bupivacaine.

Data Collection: The plan details the various parameters to be recorded, including sensory and motor block characteristics, pain scores using VAS, Ramsay Sedation Scale, hemodynamic parameters, and adverse effects.

In summary, this dissertation plan proposes a well-structured study to compare the efficacy and safety of subcutaneous dexmedetomidine and clonidine as adjuvants to spinal anesthesia for prolonging postoperative analgesia in patients undergoing lower abdominal surgeries.  The plan outlines the methodology, ethical considerations, and statistical analysis to be employed in the study.

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
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Age group between 20 and 70 years -Body weight 40 to 80 kg.
  • Patients belonging to ASA (American Society of anaesthesiologist) class-I and II.
  • Patients undergoing various infraumbilical surgeries.

排除标准

  • Patient’s refusal and uncooperative patients. -Any known hypersensitivity or contraindication to bupivacaine , clonidine and Dexmedetomidine.,.
  • Local pathology at the site of injection or disability limiting the performance of spinal block.
  • History of convulsion, altered coagulation profile, bleeding disorder, pre-existing neurological deficit, surgeries in prone position , obstructive sleep apnea, thyroid disorder, known allergy to bupivacaine, dexmedetomidine, clonidine. -Patient with history of respiratory, cardiac, hepatic or renal disease (necessitating classification in ASA Class III or above). -Patients having a history of significant neurological, psychiatric, or neuromuscular disorders.

结局指标

主要结局

duration of analgesia

时间窗: Baseline to 60 minutes

次要结局

  • -Onset and duration of sensory block.(- Onset and duration of motor block.)

研究者

发起方
JLN medical college and hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Veena Patodi

JLN medical college and hospital, Ajmer

研究点 (1)

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