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临床试验/NCT06667024
NCT06667024已完成不适用

Dexmedetomidine as an Intrathecal Adjuvant to Hyperbaric Bupivacaine for Postoperative Analgesia in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction Surgeries

Tanta University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
Total morphine consumption

研究概览

简要总结

This study aimed to evaluate the effect of adding low doses of dexmedetomidine to hyperbaric bupivacaine during spinal anesthesia on post operative analgesia characteristics in Arthroscopic Anterior Cruciate Ligament Reconstruction Surgeries

详细描述

The anterior cruciate ligament (ACL) is injured frequently during sports participation. Arthroscopic evaluation of patients with acute traumatic hemarthrosis of the knee has repeatedly demonstrated a 60% to 70% incidence of ACL injury.

Postoperative pain should be effectively treated because it represents an important component of postoperative recovery. Effective treatment serves to blunt autonomic, somatic, and endocrine reflexes with a resultant potential decrease in perioperative morbidity.

Dexmedetomidine is a highly selective α2-adrenergic agonist that has been used for premedication and as an adjunct to general anesthesia. It reduces opioid and inhalational anesthetics requirements.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged from 21 to 50 years.
  • Both genders.
  • American society of anesthesiologists (ASA) physical status I and II.
  • Patients scheduled for arthroscopic anterior cruciate ligament reconstruction surgeries under spinal anesthesia.

排除标准

  • Patient refusal.
  • Body Mass Index (BMI) more than 40 kg/m
  • Patients who were taking analgesics for chronic pain on opioid therapy or have a history of drug abuse.
  • Uncooperative patient.
  • Patients with coagulation disorders.
  • History of local anesthetics allergy.
  • Infection at the needle puncture site.
  • Patients with significant respiratory, cardiac, renal or hepatic disorders

研究组 & 干预措施

Control group

Active Comparator

Patients received the standard spinal anesthesia with 0.5% 3 ml according to the patient hyperbaric bupivacaine only.

干预措施: Hyperbaric bupivacaine (Drug)

Dexmedetomidine (study) group

Experimental

Patients received dexmedetomidine 4 μg and 0.5% (3-4 ml according to the patient's height) hyperbaric bupivacaine.

干预措施: Dexmedetomidine and Hyperbaric bupivacaine (Drug)

结局指标

主要结局

Total morphine consumption

时间窗: 24 hours postoperatively

The rescue analgesia was morphine IV bolus of 3 mg with when VAS \> 30. Total morphine consumption in the first 24 hours postoperatively was documented.

次要结局

  • Time to first rescue analgesia request(24 hours postoperatively)
  • Degree of pain(24 hours postoperatively)
  • Duration of motor block(Intraoperatively)
  • Patient satisfaction(24 hours postoperatively)
  • Incidence of side effects(24 hours postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdallah Elsayed Elkasrawy

Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

研究点 (1)

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