Dexmedetomidine Versus Ketamine Loading for Dexmedetomidine Sedation During Elective Cesarean Section Under Spinal Anesthesia: A Prospective Randomized Double-Blind Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Ramsey sedation score
研究概览
简要总结
This is a prospective, randomized, double-blind clinical study designed to compare the maternal and early neonatal effects of a loading dose of dexmedetomidine versus low-dose ketamine in parturients undergoing elective cesarean delivery under spinal anesthesia.
Participants will be randomly assigned to receive either an intravenous loading dose of dexmedetomidine (1 μg/kg) or intravenous ketamine (0.15 mg/kg) immediately after the establishment of spinal anesthesia. In both groups, sedation will be maintained with a continuous dexmedetomidine infusion at a rate of 0.5 μg/kg/h.
The primary and secondary outcomes include maternal hemodynamic parameters, sedation levels, patient and surgeon satisfaction scores, neonatal Apgar scores, and perioperative adverse events.
详细描述
This prospective, randomized, double-blind clinical study is designed to evaluate and compare the maternal and early neonatal effects of a loading dose of dexmedetomidine versus low-dose ketamine in parturients undergoing elective cesarean delivery under spinal anesthesia.
After providing written informed consent, eligible parturients will be randomly assigned to one of two study groups. Randomization will be performed using a computer-generated randomization sequence. Blinding will be maintained for both participants and outcome assessors.
Following the establishment of spinal anesthesia, patients will receive either an intravenous loading dose of dexmedetomidine (1 μg/kg) or ketamine (0.15 mg/kg). In both groups, sedation will be maintained with a continuous infusion of dexmedetomidine at a rate of 0.5 μg/kg/h throughout the intraoperative period.
Maternal hemodynamic parameters (including heart rate and blood pressure), sedation levels, patient and surgeon satisfaction scores, neonatal Apgar scores, and perioperative adverse events will be recorded at predefined time points throughout the perioperative period. Standard anesthetic and surgical care will be provided to all participants.
The primary objective of the study is to compare the effects of dexmedetomidine and ketamine on maternal hemodynamic stability. Secondary outcomes include the quality of sedation, patient and surgeon satisfaction, neonatal outcomes, and perioperative adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists (ASA) physical classification status I patients
- •aged >18 years scheduled for cesarean/section surgery under spinal anesthesia were enrolled to the study
排除标准
- •known sensitivity or allergy to study drugs
- •a history of analgesic or narcotic abuse
- •any contraindications for spinal anesthesia
- •emergency cesarean/section
- •existing of fetal distress.
结局指标
主要结局
Ramsey sedation score
时间窗: 1)immediately before spinal anesthesia (SA) 2)5 minutes after SA, 3)immediately after the loading dose was completed, 4)immediately before surgical incision, 5)5 minutes after surgical incision, 6)5 minutes after the surgical closure.
Sedation score was evaluated by Ramses Sedation Score (RSS). RSS score was as follow: Awake; agitated or restless or both =1 Awake; cooperative, oriented, and tranquil=2 Awake but responds to commands only=3 Asleep; brisk response to light glabellar tap or loud auditory stimulus=4 Asleep; sluggish response to light glabellar tap or loud auditory stimulus=5 Asleep; no response to glabellar tap or loud auditory stimulus=6
次要结局
- hemodynamic parameters(In the operating room; from immediately before the induction of anesthesia to transferring to ward with 5 minutes intervals)
- patient and surgeon satisfaction scores(at day 1 postoperatively.)
- APGAR score(The Apgar score is assessed at 1 minute and 5 minutes after birth.)
研究者
Sinan Uzman
Associate prof.
Haseki Training and Research Hospital