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临床试验/CTRI/2025/09/094930
CTRI/2025/09/094930尚未招募3 期

COMPARING DEXMEDETOMIDINE TO MAGNESIUM SULPHATE ON HEMODYNAMIC RESPONSE IN HYPERTENSIVE PATIENTS IN LAPAROSCOPIC SURGERY

ESI PGIMSR Hospital Manicktala1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
1. Changes in systolic blood pressure (SBP) at predefined time intervals

研究概览

简要总结

Hypertensive patients commonly exhibit exaggerated cardiovascular responses to perioperative stressors such as laryngoscopy, intubation, pneumoperitoneum creation and extubation. Laparoscopic surgery further provokes sympathetic activation through increased intra-abdominal pressure and carbon dioxide insufflation, potentially precipitating perioperative ischemia or hemodynamic instability in patients with chronic hypertension. This present prospective interventional study will evaluate which of the two drugs between Dexmedetomidine and Magnesium Sulphate is associated with better hemodynamic control and perioperative stability in hypertensive patients undergoing laparoscopic procedures.

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

入选标准

  • Diagnosed hypertensive patients on regular treatment Age 25-65 years Either sex ASA class II Scheduled for elective laparoscopic procedure Surgery duration minimum 40 minutes.

排除标准

  • Incidence of bradycardia HR less than 50 bpm
  • Incidence of hypotension MAP less than 60 mmHg
  • Requirement for rescue medications
  • Intraoperative anesthetic requirements
  • Time to extubation
  • Post-operative sedation scores.

结局指标

主要结局

1. Changes in systolic blood pressure (SBP) at predefined time intervals

时间窗: baseline, post-intubation, post-pneumoperitoneum creation, | every 15 minutes during pneumoperitoneum, end of pneumoperitoneum, | post-extubation

2. Changes in diastolic blood pressure (DBP) at predefined time intervals

时间窗: baseline, post-intubation, post-pneumoperitoneum creation, | every 15 minutes during pneumoperitoneum, end of pneumoperitoneum, | post-extubation

3. Changes in mean arterial pressure (MAP) at predefined time intervals

时间窗: baseline, post-intubation, post-pneumoperitoneum creation, | every 15 minutes during pneumoperitoneum, end of pneumoperitoneum, | post-extubation

4. Changes in heart rate (HR) at predefined time intervals

时间窗: baseline, post-intubation, post-pneumoperitoneum creation, | every 15 minutes during pneumoperitoneum, end of pneumoperitoneum, | post-extubation

次要结局

  • 1. Incidence of bradycardia(2. Incidence of hypotension)

研究者

发起方
ESI PGIMSR Hospital Manicktala
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Surajit Goswami

ESI PGIMSR & Hospital, Manicktala

研究点 (1)

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