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临床试验/NCT06082232
NCT06082232尚未招募4 期

Intrathecal Dexmedetomidine Versus Midazolam as Adjuvants With Intrathecal Bupivacaine for Postoperative Analgesia in High Tibial Osteotomy. A Randomized, Prospective, Double- Blinded, Comparative Study.

Assiut University0 个研究点目标入组 90 人开始时间: 2023年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
90
主要终点
Time to first analgesic request

研究概览

简要总结

The aim of this study is to compare the postoperative analgesic effect of intrathecal dexmedetomidine combined with bupivacaine and midazolam combined with bupivacaine in high tibial osteotomy.

详细描述

With more than 80% of patients experiencing acute pain following surgical procedures, and half of them reporting inadequate pain therapy, the control and management of post-surgical pain remains one of the most challenging aims of modern anesthesia.

Adequate postoperative pain control is an important part of postoperative care treatment. World Health Organization, as well as International Association for the Study of Pain, have emphasized its significance for patients well-being, and determined pain relief to be a human right and the occurrence of pain as fifth vital sign.

Local anesthetic, bupivacaine, is the most common agent used for spinal anesthesia but has relatively short duration of action. Many adjuvants to local anesthetics have been used intrathecally to improve the quality of intraoperative analgesia and prolong it in the postoperative period.

Diverse classes of drugs such as opioids , epinephrine , neostigmine , magnesium , midazolam , ketamine , and clonidine have been added to intrathecal local anaesthetics in an attempt to prolong analgesia and reduce the incidence of adverse events.

Opioids are commonly added to local anaesthetics to produce spinal and epidural anesthesia. However, significant adverse effects such as, urinary retention, respiratory depression, hemodynamic instability, pruritus and occasionally severe nausea and vomiting, may limit their use .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged 18-60 years.
  • Gender: Both males and females.
  • Scheduled patients for High tibial osteotomy under spinal anesthesia.
  • American Society of Anesthesiologists (ASA) physical status: I and II

排除标准

  • Patient refusal
  • Allergy to the studied drugs.
  • Patients with contraindications to spinal anesthesia.
  • Patients with advanced decompensated cardiac, respiratory,renal or hepatic diseases
  • Coagulopathy or thrombocytopenia
  • CNS diseases as epilepsy, stroke or psychiatric illness.

研究组 & 干预措施

Group M (midazolam group)

Active Comparator

includes thirty patients who receive intrathecal 4 mL (20 mg) 0.5% hyperbaric bupivacaine and 1 mg midazolam (8 units of 5 mg/mL preservative-free midazolam loaded in a 40 unit insulin syringe).

干预措施: Midazolam (Drug)

Group M (midazolam group)

Active Comparator

includes thirty patients who receive intrathecal 4 mL (20 mg) 0.5% hyperbaric bupivacaine and 1 mg midazolam (8 units of 5 mg/mL preservative-free midazolam loaded in a 40 unit insulin syringe).

干预措施: Bupivacain (Drug)

Group D(dexmedetomidine group)

Active Comparator

includes thirty patients who receive intrathecal 4 mL (20 mg) 0.5% hyperbaric bupivacaine and 5 mcg dexmedetomidine (2 units of 100 mcg/mL preservative-free dexmedetomidine loaded in a 40 unit insulin syringe).

干预措施: Dexmedetomidine (Drug)

Group D(dexmedetomidine group)

Active Comparator

includes thirty patients who receive intrathecal 4 mL (20 mg) 0.5% hyperbaric bupivacaine and 5 mcg dexmedetomidine (2 units of 100 mcg/mL preservative-free dexmedetomidine loaded in a 40 unit insulin syringe).

干预措施: Bupivacain (Drug)

Group C(control group)

Placebo Comparator

includes thirty patients who receive intrathecal 4 mL (20 mg) 0.5% hyperbaric bupivacaine and 0.5 mL of 0.9% saline .

干预措施: Bupivacain (Drug)

结局指标

主要结局

Time to first analgesic request

时间窗: 24 hours

Time to first analgesic request calculated from the administration of local anesthetic

次要结局

  • analgesic consumption(24 hours)
  • Incidence of complications(24 hours)

研究者

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

Ahmed Sayed Ali Farghali

Doctor

Assiut University

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