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临床试验/CTRI/2025/06/089294
CTRI/2025/06/089294尚未招募4 期

Comparative Study between dexmedetomidine infusion and remifentanil infusion for hypotensive anesthesia in controlled hypertensive patients undergoing spine surgeries

IMS&SUM hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月1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
60
试验地点
1
主要终点
To compare the efficacy of dexmedetomidine versus remifentanil in achieving controlled hypotension during spine surgeries

研究概览

简要总结

Controlled hypotension is crucial in spine surgeries to minimize blood loss and improve the surgical field, yet managing it in controlled hypertensive patients presents unique challenges.

Remifentanil, an ultra-short-acting opioid, allows for rapid blood pressure control.However, it can cause bradycardia, respiratory depression, and lacks postoperative analgesia. Rebound hypertension is also a concern.

Dexmedetomidine, a selective alpha-2 agonist, offers sedation, analgesia-sparing effects, and hemodynamic stability by reducing sympathetic outflow.Studies suggest it can achieve controlled hypotension with potentially fewer bradycardic episodes and smoother recovery.However, its slower onset is a consideration.

While both agents are used for controlled hypotension, direct comparisons in controlled hypertensive patients undergoing spine surgery are limited. Hypertensive individuals may exhibit different responses due to altered hemodynamics . Understanding the optimal agent regarding intraoperative stability, postoperative outcomes, and side effects in this specific population is vital. This thesis aims to compare dexmedetomidine and remifentanil infusions for hypotensive anesthesia in controlled hypertensive patients undergoing spine surgeries, contributing evidence for informed clinical decision-making in this challenging context

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
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients posted for elective spine surgeries with controlled hypertension 2.Age group of 20 to 65 years 3.Patients belonging to ASA class-2 4.Patients who have given informed consent to participate in the study.

排除标准

  • 1.Patient not giving consent 2.known allergy to either drug 3.Opioid dependence 4.Any coagulation disorders 5.Patient taking anticoagulant drugs 6.Re-operative surgery 7.Uncontrolled hypertension & diabetes 8.Patients with significant cardiovascular or respiratory diseases 9.Patients with neurological or psychiatric disorders affecting pain perception reporting.

结局指标

主要结局

To compare the efficacy of dexmedetomidine versus remifentanil in achieving controlled hypotension during spine surgeries

时间窗: Baseline, 10 minutes, 30 minutes, 60 minutes, at extubation, 30 minutes after extubation, 60 minutes after extubation, 90 minutes after extubation

次要结局

  • To evaluate intraoperative blood loss, hemodynamic stability, Postoperative pain scores(VAS), duration of sedation and adverse effects associated with each agent(Baseline, 10 minutes, 30 minutes, 60 minutes, at extubation, 30 minutes after extubation, 60 minutes after extubation, 90 minutes after extubation)

研究者

发起方
IMS&SUM hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr.Kamma Manisha chowdary

IMS&SUM hospital

研究点 (1)

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