跳至主要内容
临床试验/CTRI/2024/11/077026
CTRI/2024/11/077026尚未招募4 期

Effect of intrathecal dexmedetomidine (3µg vs 5µg) as an adjuvant to hyperbaric ropivacaine in cesarean section: A randomized double blind clinical study

Government Medical College Baroda1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2024年11月29日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
126
试验地点
1
主要终点
1.Monitoring of spinal characteristics (sensory and motor blockade, satisfaction of spinal anesthesia, visceral traction response, the quality of abdominal muscle relaxation and shivering & sedation score)

研究概览

简要总结

We first determined whether dexmedetomidine combined with intrathecal hyperbaric ropivacaine could improve Hemodynamic stability during cesarean section with block characteristics and prolong postoperative sensory block with no effect on the motor block. Then, we determined which dose of dexmedetomidine was better.

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
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • 1.Age Group – 18 years to 40 years 2.ASA – I/II 3.Elective Caesarean section.

排除标准

  • 1.Patients Refusal 2.Multifetal pregnancy 3.Heart block & ventricular dysfunction 4.Patient on anticoagulant therapy 5.Patient with local site infection 6.Patients with allergy to study drugs 7.Fetal distress in utero.
  • 8.Severe hypovolemia.
  • 9.Severe operative blood loss expected.
  • (Placenta Previa, Accrete etc.) 10.Height less than or equal to 150cm.

结局指标

主要结局

1.Monitoring of spinal characteristics (sensory and motor blockade, satisfaction of spinal anesthesia, visceral traction response, the quality of abdominal muscle relaxation and shivering & sedation score)

时间窗: Till 24hrs

2.Hemodynamic stability (intraoperative)

时间窗: Till 24hrs

次要结局

  • 1.Postoperative analgesia score (VAS SCORE)(2. Apgar score of neonates)

研究者

发起方
Government Medical College Baroda
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Praveen Rathod

Government Medical College Baroda

研究点 (1)

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