Evaluation of the Analgesic Efficacy of Free Opioid Anesthesia for Patients Undergoing Colectomies and Rectal Resections: A Prospective, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- analgesic efficacy of free-opioid anesthesia
研究概览
简要总结
Objectives: To compare free-opioid anesthesia (the combination of epidural anesthesia, intravenous lidocaine, ketamine, propofol, and sevoflurane) and opioid anesthesia (fentanyl, propofol and sevoflurane) regarding intraoperative analgesic efficacy in colectomies and rectal resections at Viet Tiep Friendship Hospital.
Methods: A prospective, randomized controlled clinical trial was performed on 98 patients who were anesthetized for colorectal surgery from December 2019 to November 2021. Patients were randomized into 2 groups: Group OA - Opioid anesthesia (n = 49): Intraoperative pain control by fentanyl; FOA group - Free-opioid anesthesia (n = 49): Intraoperative pain control by continuous infusion of lidocaine, bolus doses of ketamine combined with epidural levobupivacaine.
详细描述
After being placed an epidural catheter and given a bolus dose of dexamethasone 0.1 mg/kg, patients was endotracheal anesthetized with propofol 1% 2-2.5 mg/kg, rocuronium 0.6 mg/kg. Intubation was implemented when TOF (Train Of Four)=0 and RE (Response Entropy), SE (State Entropy) ≤ 60. Patients in OA group received a bolus dose of fentanyl 2 µg/kg before induction of anesthesia while those in FOA group received bolus doses of lidocaine 1 mg/kg and ketamine 0.5 mg/kg. In FOA group, lidocaine 10% was sprayed on the patients glottis to facilitate intubation.
For anesthesia maintenance, in group OA, a bolus dose of fentanyl 3 µg/kg was given 5 minutes before skin incision, and then a continuous infusion of fentanyl 2 µg/kg/h was maintained for intraoperative pain management; fentanyl 0.5 μg/kg was bolused when SPI (Surgical Pleth Index) > 50, 40 < SE < 60, TOF = 0 and the patient was hemodynamically stable. Propofol and fentanyl were discontinued at the start of skin closure. In FOA group, patients received intraoperative multimodal analgesia, in which an epidural bolus of 3 - 5 ml of levobupivacaine 0.1% was followed by a continuous infusion of 3 - 5 ml/h epidurally; in addition, intravenous infusion of lidocaine 1 mg/kg/hour and ketamine 0.25 mg/kg/h were maintained until the end of surgery. Patients were given a bolus of 3-5 ml levobupivacaine 0.1% epidurally and ketamine 0.25 mg/kg intravenously if SPI > 50, 40 < SE < 60, TOF = 0 and hemodynamics was stable.
For all patients, anesthesia was maintained by volatile anesthetics (Sevoflurane or Desflurane) to ensure 40 < SE < 60, and rocuronium 0.2 mg/kg was repeated when TOF = 2 (the last injection of neuromuscular blockade was not given when the estimated duration from the point of injection to the point of abdominal closure is shorter than 20 minutes). Mechanical ventilation was provided with a tidal volume 6-8 ml/kg in the volume-controlled mode and respiratory rate at 10-12 breath/minute, FiO2 (Fraction of inspired oxygen)=50%. Peak airway pressure was maintained within the range of 12-16 cmH2O and EtCO2 (End-tidal Carbon dioxide) was kept from 35 to 40 mmHg with a fresh gas flow of 1.2 - 2 liters/minute. At the end of surgery, reversal of neuromuscular blockade was performed with neostigmine combined with atropine, and extubation was carried out when patients met the criteria. Postoperative pain management was implemented with patient-controlled epidural levobupivacaine 0.1% for 72 hours, and pain rescue with fentanyl 0.5 μg/kg.
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, Care Provider, Outcomes Assessor)
盲法说明
The drugs were administered in 10 mL and 50 mL syringes labeled as ''loading'' or ''infusion'' respectively. All the drugs delivered in loading dose (intravenous lidocaine and ketamine, epidural levobupivacaine in FOA group; fentanyl and normal saline in OA group) were diluted in normal saline to 10 ml volume labeled indistinguishably as ''loading-1'' and ''loading-2'', "loading-3"…. Because the number of loading drugs in the FOA group was greater than in OA group, investigators added some 10 ml normal saline syringes in the OA group to make the number of "loading" syringes in the two groups equal, thereby ensuring complete blinding. The infusion drugs (lidocaine, ketamine and levobupivacaine in FOA group or normal saline in OA group) were prepared in 50 mL syringes and labeled as ''infusion-1'' and''infusion-2'' respectively. The patients and the anesthetists taking part in the procedures were not informed of the study protocol.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients agreed to participate in the study.
- •Patients aged ≥ 18 years old,
- •Those who underwent elective colectomies or rectal resections,
- •Those who were ASA (American Society of Anesthesiologists) classified as I - III,
- •Those who were indicated for general endotracheal anesthesia from December 2019 to November 2021 at Viet Tiep Friendship Hospital
排除标准
- •Patients refused to participate in the study,
- •Patients had BMI (Body Mass Index) ≥ 35;
- •Pregnant or lactating or menstruating women;
- •Those who had liver failure, renal failure, heart failure, history of chronic pain, alcohol or drug abuse, mental illnesses, allergies or contraindications to any studied medications.
- •Those who were unable to assess pain or use of patient-controlled analgesia devices (PCA).
结局指标
主要结局
analgesic efficacy of free-opioid anesthesia
时间窗: postoperatively (upto 3 days after surgery)
the proportion of patients requiring postoperative pain rescue
次要结局
- Effects of free-opioid anesthesia on intraoperative heart rate(T16 (15 minutes after extubation))
- Adverse effects of free-opioid anesthesia(up to 3 days postoperatively)
- changes in the concentration of IL (Interleukin)-6(1 hour after surgery)
- changes in the concentration of IL-10(1 hour after surgery)
- Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure(T16 (15 minutes after extubation))
研究者
Nguyen Trung Kien
Assoc. Prof, Nguyen Trung Kien, PhD, MD. Director of Center of Emergency, Critical Care Medicine and Clinical Toxicology, Military Hospital 103, Vietnam Military Medical University, Vietnam
Vietnam Military Medical University
