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临床试验/CTRI/2023/09/057299
CTRI/2023/09/057299尚未招募1/2 期

Comparative study of the duration of post operative analgesia with different doses of intrathecal Dexmedetomidine as adjuvant to 0.5% Hyperbaric Bupivacaine & with Bupivacaine alone in Total Abdominal Hysterectomy surgeries. - randomized double blind study.

Jubilee Mission Medical College and Research Institute1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年9月15日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Dexmedetomidine 10 mcg was a better adjuvant compared to 5 mcg in terms of better post operative analgesia when used as intrathecal adjuvant to Bupivacaine in subarachnoid block

研究概览

简要总结

This study is being undertaken  to evaluate and compare the duration of postoperative analgesia with different doses of intrathecal  Dexmedetomidine , as adjuvant to  Bupivacaine  in Total  Abdominal  Hysterectomy surgeries , and their side effect profile ( As evidenced by Hypotension  and Bradycardia ).Dexmedetomidine 10 mcg was a better adjuvant compared to 5 mcg in terms of better post operative analgesia without increased incidence of side effects  when used as intrathecal adjuvant to Bupivacaine in subarachnoid block

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Double Blind Double Dummy

入排标准

年龄范围
35.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • ASA I & ASA II PATIENTS SCHEDULED TOTAL ABDOMINAL HYSTERECTOMY.

排除标准

  • Patients with baseline Heart rate < 60 or on Beta blockers / Alpha agonist.
  • Patient refusal for study participation .
  • Local infection at injection site.
  • Presence of any coagulopathies or bleeding disorders or patients on anticoagulation.
  • PRESENCE OF NEUROLOGICAL DEFICITS, PERIPHERAL NEUROPATHIES, MYOPATHIES, OR CHRONIC PAIN IN THE OPERATING LIMB.
  • PATIENTS WITH KNOWN ALLERGY TO LOCAL ANAESTHETICS OR TO ANY STUDY DRUGS TO BE USED.
  • HEMODYNAMICALLY COMPROMISED PATIENTS ALCOHOLIC/ PSYCHIATRIC/UNCOOPERATIVE PATIENTS PATIENTS WITH HEPATIC / RENAL OR CARDIOPULMONARY DISORDERS.
  • PATIENTS LESS THAN 5 FEET HEIGHT.
  • TOTAL ABDOMINAL HYSTERECTOMY TAKING > 3 HRS.

结局指标

主要结局

Dexmedetomidine 10 mcg was a better adjuvant compared to 5 mcg in terms of better post operative analgesia when used as intrathecal adjuvant to Bupivacaine in subarachnoid block

时间窗: Post operative analgesia assessed every 6 hours after the requirement of first dose of analgesic

次要结局

  • Onset of sensory block(Onset of motor block)

研究者

发起方
Jubilee Mission Medical College and Research Institute
申办方类型
Research institution and hospital

研究点 (1)

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