A Comparative Study of Two Different Doses of Dexmedetomidine for Hypotensive Anaesthesia in Patients Undergoing Functional Endoscopic Sinus Surgery
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 proportion of 5-minute non-invasive blood pressure (NIBP) readings achieving the target mean arterial pressure (MAP) during surgery (from induction to extubation) between the two dexmedetomidine groups (0.25 mcg/kg vs. 0.5 mcg/kg).
研究概览
简要总结
Functional Endoscopic Sinus Surgery (FESS) is a commonly performed procedure where a bloodless surgical field is critical for success. Controlled hypotensive anaesthesia is often used to minimize intraoperative bleeding and improve visualization. Dexmedetomidine, a selective alpha 2 adrenergic agonist, is widely employed for this purpose due to its sedative, analgesic, and sympatholytic properties. However, the optimal bolus dose for achieving effective hypotension with minimal adverse effects remains unclear.
This prospective, randomized, double blind, active controlled study aims to compare the efficacy and safety of two different bolus doses of intravenous dexmedetomidine, 0.25 microgram per kilogram and 0.5 microgram per kilogram, administered over 30 minutes after induction of general anaesthesia in patients undergoing elective FESS. Sixty patients aged 18 to 65 years, ASA physical status I or II, will be randomly allocated into two groups of 30 each using computer generated randomization with allocation concealment.
The primary outcome will be the proportion of intraoperative mean arterial pressure readings within the target range, defined as 55 to 65 mmHg for non hypertensive patients, or 15 to 20 percent below baseline mean arterial pressure for controlled hypertensives. Secondary outcomes will include postoperative sedation assessed by Ramsay Sedation Score, and incidence of adverse events such as hypotension and bradycardia.
The study seeks to determine whether either of the two lower bolus doses of dexmedetomidine, 0.25 or 0.5 microgram per kilogram, is sufficient to achieve controlled hypotension during FESS with fewer adverse effects when compared to higher doses reported in previous studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 to 65 years undergoing elective FESS under general anaesthesia.
- •American Society of Anesthesiologists (ASA) Class I and II (patients with no comorbidities or well-controlled comorbidities).
排除标准
- •ASA Class III and above.
- •Patients aged less than 18 years or more than 65 years.
- •Patients with severe cardiac dysfunction or conduction blocks.
- •Patients allergic to study drugs.
- •Patients with coagulopathies or uncontrolled hypertension.
- •Patients unwilling to participate in the study.
- •Patients with cognitive or psychiatric disturbances.
- •Patients requiring postoperative ventilation.
- •Duration of Surgery longer than 2.5 hours.
结局指标
主要结局
To compare the proportion of 5-minute non-invasive blood pressure (NIBP) readings achieving the target mean arterial pressure (MAP) during surgery (from induction to extubation) between the two dexmedetomidine groups (0.25 mcg/kg vs. 0.5 mcg/kg).
时间窗: Assessed intraoperatively, from induction of anaesthesia until extubation, with MAP recorded every 5 minutes.
次要结局
- Postoperative sedation measured using the Ramsay Sedation Score every 15 minutes for the first hour post-extubation. The mean score per patient is compared between groups.(Assessed at 15, 30, 45, & 60 minutes after extubation in the recovery room.)
- To evaluate the incidence of intraoperative adverse effects (hypotension, defined as a single 5-minute NIBP reading with MAP less than 55 mmHg, or bradycardia, HR less than 60 per min) as a safety measure.(Assessed intraoperatively, from induction of anaesthesia until extubation.)
研究者
Kaushik M
Naruvi Hospitals