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临床试验/NCT07051512
NCT07051512已完成1 期

Effect of Different Doses Of Intrathecal Dexmedetomidine In Combination With Bupivacaine On Spinal Anesthesia And Its Postoperative Analgesic Effects In Patients Undergoing Infra-Umbilical Surgeries.

Tanta University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年7月1日最近更新:
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
90
试验地点
1
主要终点
intrathecal dexmedetomidine dose

研究概览

简要总结

This study is designed to assess the efficacy of different doses of dexmedetomidine in combination with intrathecal hyperbaric bupivacaine on spinal anesthesia and its postoperative analgesic characteristics on patients undergoing infra-umbilical procedures.

Primary outcome:

To ascertain a safe intrathecal dexmedetomidine dose for patients undergoing elective lower abdominal and lower limb surgeries

Secondary outcomes:

Assessment of level of sedation. Assessment of hemodynamic parameters (Blood Pressure -Heart Rate). Assessment of level of sensory & motor block. Assessment of pain.

详细描述

Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage. A pain free and stress free postoperative period helps in early mobilization and recovery of surgical patients, thereby reducing morbidity. Intraoperative and postoperative pain relief is a fundamental component of anesthesia. Accordingly, anesthesiologists constantly strive to offer the best possible anesthetic technique with emphasis on minimum adverse effects and satisfactory perioperative analgesia. Spinal anesthesia is a preferred technique to administer anesthesia for infraumbilical operations. However, postoperative pain control is a matter of concern with spinal anesthesia using only local anesthetics, as the analgesic effect lasts for a relatively short duration. Thus, early analgesic intervention is needed in the postoperative period.

Various adjuvants, such as opioids, epinephrine, neostigmine, magnesium, midazolam, ketamine, clonidine, have been used with intrathecal local anesthetics in attempts to prolong analgesia and reduce the incidence of adverse events. In recent years, α2-adrenergic receptor agonists have gained popularity as an important adjunct in anesthetic practice, whether it be general or regional anesthesia.

Dexmedetomidine is selective alpha-2 agonist with favorable analgesic, sedative, anxiolytic, and sympatholytic features. Researchers have used dexmedetomidine intrathecally in varying doses with varying results. Despite extensive research, no consensus on optimal dose of intrathecal dexmedetomidine exists, since with higher doses there is better intraoperative and post-operative analgesia, but there is an increased likelihood of hemodynamic disturbances.

This prompted us to conduct this research to study varying doses of intrathecal dexmedetomidine to compare the prolongation of sensory and motor block duration with dosage ranging from as low as 4 μg to as high as 10 μg as adjuvant along with 0.5% hyperbaric bupivacaine. Anticipated benefits/outcomes included prolongation of sensory and motor block with reduced/ delayed need of rescue analgesics in the post-operative period and with reduced intraoperative and post-operative side effects.

This study is designed to assess the efficacy of different doses of dexmedetomidine in combination with intrathecal hyperbaric bupivacaine on spinal anesthesia and its postoperative analgesic characteristics on patients undergoing infra-umbilical procedures.

研究设计

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

盲法说明

All techniques will be performed by one anesthesiologist while the measurements will be taken by another anesthesiologist who is blinded to the study groups and has no subsequent involvement in the study.

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

  • Age 18-60 years of either sex.
  • American Society of Anesthesiologists physical status I and II.
  • undergoing elective lower abdominal and lower limb surgeries under planned subarachnoid block.

排除标准

  • patient refusal
  • contraindication to subarachnoid block (hypersensitivity to the drugs - infection at the site of injection)
  • significant comorbid conditions like congestive heart failure, coagulopathy, heart block
  • pregnancy.

研究组 & 干预措施

Group (I):dexmedetomidine 4μg

Experimental

Group (I): in this group patients will receive (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 4μg)

干预措施: dexmedetomidine 4μg (Drug)

Group (II): dexmedetomidine 8 μg

Experimental

Group (II): in this group patients will receive (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 8 μg)

干预措施: dexmedetomidine 8 μg (Drug)

Group (III): dexmedetomidine 10 μg

Experimental

Group (III): in this group patients will receive (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 10 μg

干预措施: dexmedetomidine 10 μg (Drug)

结局指标

主要结局

intrathecal dexmedetomidine dose

时间窗: 2 hours

To ascertain a safe intrathecal dexmedetomidine dose for patients undergoing elective lower abdominal and lower limb surgeries.3. The sensory block level will be assessed at 5 min , 20 min after administration of spinal anesthesia and every 15 min postoperative until two segment sensory regression.

A safe intrathecal dexmedetomidine dose for patients

时间窗: Intraoperative during 2 hours

To ascertain a safe intrathecal dexmedetomidine dose for patients undergoing elective lower abdominal and lower limb surgeries

次要结局

  • pain by Visual analogue scale(24 hours postoperatively.)
  • intraoperative sedation level using the Ramsay sedation scale(24 hours post-spinal injection)

研究者

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

Marwa Gamal Abd-Elnaby Elakraa

Resident

Tanta University

研究点 (1)

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