The Effect of Opioid Free Anesthesia on the Postoperative Opioid Consumption in Laparoscopic Bariatric Surgeries: Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Postoperative opioid consumption
研究概览
简要总结
This is a prospective randomized controlled study that will be carried out on morbid obese patients admitted to Tanta University hospitals for laparoscopic bariatric surgeries. The patients will be randomly assigned into;- Control group:- Anesthesia will be induced by fentanyl 1 ug/kg, propofol 2 mg/kg, and rocuronium 1 mg/kg to facilitate tracheal intubation. Anesthesia will be maintained by sevoflurane 2% in a mixture of oxygen: Air 1: 1 to maintain entropy 40-60.
Opioid free anesthesia group;- Anesthesia will be induced by propofol 2 mg/kg, rocuronium 1 mg/kg to facilitate tracheal intubation. After endotracheal intubation, and a combination of dexmedetomidine and ketamine infusion. Anesthesia will be maintained by sevoflurane 2% in a mixture of oxygen: Air 1: 1 and continuing the infusion of dexmedetomidine and ketamine o maintain entropy 40-60.
详细描述
This prospective randomized controlled study will be carried out on patients who will be presented for laparoscopic bariatric surgery in the general surgery department in Tanta university hospitals over six-month duration that will start immediately after obtaining ethical committee approval and clinical trial registration. An informed written consent will be obtained from all the participants, all patients data will be confidential and will be used for the current study only.
Inclusion criteria:
Morbid obese patients with BMI 40-50 kg/m2 aged more than 21 years and American Society of Anesthesiologists Class III presented for laparoscopic sleeve gastrectomy or gastric bypass.
Exclusion criteria:
- Patients refused to participate.
- Patients with known or suspected or known allergy to the used medication.
- Patients with moderate to severe obstructive sleep apnea
- Patients with uncontrolled blood sugar, cardiac, renal, or hepatic functions.
- Patients receiving opioids preoperatively
- Uncooperative patients
- Patients received preoperative gabapentoids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double blinded study Closed sealed envelops will be used to make the participants blind to their group.
The continuous infusion regimen in the syringe pump will be prepared by anesthesia resident who will not participating in the the study . It will contain normal saline in control group and actual dexmedetomidine and ketamine in the other group. This will make the investigator blind to the group.
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Morbid obese patients with BMI 40-50 kg/m2
- •Aged more than 21 years and American Society of Anesthesiologists Class III
- •Presented for laparoscopic sleeve gastrectomy or gastric bypass.
排除标准
- •Patients refused to participate.
- •Patients with known or suspected or known allergy to the used medication.
- •Patients with moderate to severe obstructive sleep apnea
- •Patients with uncontrolled blood sugar, cardiac, renal, or hepatic functions.
- •Patients receiving opioids preoperatively
- •Uncooperative patients
- •Patients received preoperative gabapentoids.
研究组 & 干预措施
Control group
Anesthesia will be induced by fentanyl 1 ug/kg, propofol 2 mg/kg, and rocuronium 1 mg/kg to facilitate tracheal intubation. After endotracheal intubation, the patients will be connected to mechanical ventilator with its parameters adjusted to maint5ain etCO2 32-36 mmhg. Anesthesia will be maintained by sevoflurane 2% in a mixture of oxygen: Air 1: 1 to maintain entropy 40-60. The patients in this group will be connected to a syringe pump before induction of anesthesia that was prepared by anesthesia resident not participating in the study and contain normal saline and adjusted at a rate of 1 ml/kg/hr till the end of the surgery.
干预措施: Fentanyl (Drug)
Opioid free anesthesia group
A syringe 50 ml was prepared by anesthesia resident not participating in the study and contain 100 ug of dexmedetomidine (2 ug/ml) and 25 mg ketamine 90.5 mg/ml) and 200 mg lidocaine (4 mg/ml). The syringe will be connected to the patients before induction of anesthesia at a rate of 0.1 ml/kg/hr according to the ideal body weight. Anesthesia will be induced by propofol 2 mg/kg, and rocuronium 1 mg/kg to facilitate tracheal intubation. After endotracheal intubation, the patients will be connected to mechanical ventilator with its parameters adjusted to maint5ain etCO2 32-36 mmhg. Anesthesia will be maintained by sevoflurane 2% in a mixture of oxygen: Air 1: 1 to maintain entropy 40-60. The syringe infusion will be continued till the end of peritoneal manipulation. Patients in this group will receive magnesium sulphate preload at a dose of 40 mg/kg ideal body weight followed by maintenance infusion of 10 mg/kg/hr.
干预措施: Dexmedetomidine Ketamine (Drug)
结局指标
主要结局
Postoperative opioid consumption
时间窗: The first 24 hours postoperatively
The total dose of morphine consumed postoperative as a rescue analgesia to maintain the VAS less than 4
次要结局
- Intraoperative sevoflurane consumption(Through out the whole intraoperative period)
研究者
Sameh Abdelkhalik Ahmed Ismaiel
Dr
Tanta University