Dexmedetomidine Infusion Versus Low Dose Ketamine Infusion as an Adjuvant in Bariatric Surgery: A Randomized Controlled Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Postoperative Total Morphine Consumption
研究概览
简要总结
This randomized controlled trial aims to compare the analgesic efficacy of dexmedetomidine infusion versus low-dose ketamine infusion as adjuvants in bariatric surgery. The study includes 90 patients undergoing bariatric surgery at Menoufia University Hospital, randomized into three groups: dexmedetomidine, ketamine, and control (placebo). Primary outcomes include total morphine consumption intra- and post-operatively. Secondary outcomes include postoperative pain scores, total analgesic consumption, time to first analgesic request, hemodynamic parameters, and patient satisfaction. This study seeks to explore safer, more effective pain management strategies to minimize opioid use in bariatric surgery patients.
详细描述
This study is a prospective, randomized controlled interventional trial evaluating the analgesic efficacy and opioid-sparing effects of dexmedetomidine and low-dose ketamine as adjuvants in bariatric surgery. Ninety patients meeting the inclusion criteria will be enrolled and randomized into three groups:
- Dexmedetomidine Group: Patients will receive a bolus dose of dexmedetomidine (0.5 µg/kg) followed by a continuous infusion (0.5 µg/kg/h) until 10 minutes before the end of surgery.
- Ketamine Group: Patients will receive a bolus dose of ketamine (0.3 mg/kg) followed by a continuous infusion (0.3 mg/kg/h) until 10 minutes before the end of surgery.
- Control Group: Patients will receive an equal volume of normal saline as a placebo.
Objectives
The primary objective is to compare intra- and postoperative morphine consumption between groups. Secondary objectives include:
- Pain assessment using the Numeric Rating Scale (NRS) at multiple time points postoperatively.
- Time to first request for rescue analgesia.
- Hemodynamic stability (heart rate and mean arterial pressure).
- Patient satisfaction assessed using a 5-point scale.
- Incidence of adverse effects such as nausea, vomiting, bradycardia, and respiratory depression.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The allocation will be concealed using sequentially numbered, sealed envelopes. A nurse not involved in patient care will open the envelope after induction of anesthesia to assign patients to groups.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-60 years.
- •Both sexes.
- •Body mass index (BMI) > 35 kg/m², scheduled for bariatric surgery.
- •American Society of Anesthesiologists (ASA) physical status I-II.
排除标准
- •History of hypersensitivity to dexmedetomidine or ketamine.
- •History of substance abuse or chronic opioid use.
- •American Society of Anesthesiologists (ASA) physical status III or IV.
- •Severe hepatic or renal impairment.
- •Cardiopulmonary disorders.
- •Severe diabetes mellitus.
- •Psychiatric disorders, seizures, uncontrolled hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg), or heart block.
研究组 & 干预措施
Dexmedetomidine Group
Participants in this group will receive a bolus dose of dexmedetomidine (0.5 µg/kg ideal body weight) diluted in 0.9% normal saline over 10 minutes before induction of anesthesia. This will be followed by a continuous infusion of dexmedetomidine at 0.5 µg/kg/h until 10 minutes before the end of surgery.
干预措施: Dexmedetomidine infusion (Drug)
Control Group
Participants in this group will receive a bolus dose of 0.9% normal saline over 10 minutes before induction of anesthesia. This will be followed by a continuous infusion of 0.9% normal saline until 10 minutes before the end of surgery.
干预措施: Normal Saline Infusion (Placebo) (Drug)
Ketamine Group
Participants in this group will receive a bolus dose of ketamine (0.3 mg/kg ideal body weight) diluted in 0.9% normal saline over 10 minutes before induction of anesthesia. This will be followed by a continuous infusion of ketamine at 0.3 mg/kg/h until 10 minutes before the end of surgery.
干预措施: Ketamine infusion (Drug)
结局指标
主要结局
Postoperative Total Morphine Consumption
时间窗: Within the first 24 hours postoperatively
The total dose of morphine, measured in mg, administered to each participant during the first 24 hours postoperatively for pain control.
Total Morphine Consumption Intra- and Postoperatively
时间窗: From the start of anesthesia to 24 hours postoperatively
The total dose of morphine (measured in mg) consumed by participants intraoperatively and within the first 24 hours postoperatively. This includes morphine administered as part of the anesthesia protocol and as rescue analgesia post-surgery.
次要结局
- Intraoperative Fentanyl Consumption(Intraoperatively (From induction of anesthesia until the end of surgery))
- Postoperative Pain Scores (Numeric Rating Scale - NRS)(At 1, 2, 4, 8, 12, 16, and 24 hours postoperatively)
- Time to First Request for Rescue Analgesia(24 hours postoperatively)
- Hemodynamic Stability (Heart Rate)(From baseline (pre-surgery) to 24 hours postoperatively)
- Hemodynamic Stability (Mean Arterial Pressure)(From baseline (pre-surgery) to 24 hours postoperatively)
- Total Analgesic Consumption (Other Than Morphine)(At 24 hours postoperatively)
- Patient Satisfaction with Pain Management(At 24 hours postoperatively)
研究者
Ahmed Abdalla Shalaby
Anesthesiology, Intensive Care and Pain Management Resident
Menoufia University