Intrathecally Administered Ketamine, Dexmedetomidine, and Their Combination With Bupivacaine for Postoperative Analgesia in Major Abdominal Cancer Surgery
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
Currently, opioids are widely used for pain relief, but they often provide sub-optimal analgesia with occasional serious side effects. Preservative-free ketamine hydrochloride was introduced as a spinal anesthetic more than twenty years ago and found to have advantages over local anesthetics. Intrathecal dexmedetomidine provides an analgesic effect in postoperative pain without severe sedation. The objectives of this study were to compare the efficacy and safety of intrathecally administered dexmedetomidine, ketamine, or their combination when added to bupivacaine for postoperative analgesia in major abdominal cancer surgery.
详细描述
This study was approved by the ethics committee of South Egypt Cancer Institute, Assiut University, Assiut, Egypt. After obtaining a written informed consent, 90 American Society of Anesthesia (ASA) I-II patients aged 30-50 years and scheduled for major abdominal cancer surgery were included in the study. Patients with a known allergy to the study drugs, significant cardiac, respiratory, renal or hepatic disease, coagulation disorder, infection at the site of intrathecal injection, drug or alcohol abuse, BMI > 30 kg/m2 , and psychiatric illnesses that would interfere with perception and assessment of pain were excluded from the study.
Preoperatively, patients were taught how to evaluate their own pain intensity using the visual analogue scale (VAS), scored from 0 -10 (where 0 = no pain, and 10 = the worst pain imaginable).
Oral diazepam (5 mg) was taken the night before surgery. Up on arrival at the operative theatre, a 16-gauge catheter was introduced intravenously at the dorsum of the hand; lactated Ringer's solution 10 mg/kg was infused intravenously over 10 min. before initiation of spinal anesthesia. Basic monitoring probes (electrocardiography, non invasive blood pressure, O2 saturation, and temperature) were applied. Patients were placed in the setting position and a 25-gauge Quincke needle was placed in the L2-3 or L3-4 interspaces.
Patients were randomly divided, by selecting sealed envelopes into one of three groups 30 patients each:
- The dexmedetomidine group (group I) received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 5µg of dexmedetomidine in 1 ml volume intrathecally.
- The ketamine group (group II) received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg ketamine in 1ml volume intrathecally.
- Dexmedetomidine + Ketamine group (group III) received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 5µg of dexmedetomidine plus 0.1 mg/kg of Ketamine in 1 ml volume intrathecally.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 30-50 years
- •American Society of Anesthesia (ASA) I-II patients
- •scheduled for major abdominal cancer surgery
排除标准
- •known allergy to the study drugs.
- •significant cardiac, respiratory, renal or hepatic disease
- •coagulation disorder
- •infection at the site of intrathecal injection
- •drug or alcohol abuse
- •BMI > 30 kg/m2
- •psychiatric illnesses that would interfere with perception and assessment of pain
研究组 & 干预措施
ketamine (II)
intrathecal drug administartion of 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg ketamine in 1ml volume.
干预措施: intrathecal drug administration (Procedure)
ketamine (II)
intrathecal drug administartion of 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg ketamine in 1ml volume.
干预措施: ketamine (Drug)
ketamine (II)
intrathecal drug administartion of 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg ketamine in 1ml volume.
干预措施: Bupivacaine (Drug)
Dexmedetomidine + Ketamine group (III)
intrathecal drug administartion of patients in this arm received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 5µg of dexmedetomidine plus 0.1 mg/kg of Ketamine in 1 ml volume.
干预措施: intrathecal drug administration (Procedure)
Dexmedetomidine + Ketamine group (III)
intrathecal drug administartion of patients in this arm received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 5µg of dexmedetomidine plus 0.1 mg/kg of Ketamine in 1 ml volume.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine + Ketamine group (III)
intrathecal drug administartion of patients in this arm received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 5µg of dexmedetomidine plus 0.1 mg/kg of Ketamine in 1 ml volume.
干预措施: ketamine (Drug)
dexmedetomidine (I)
intrathecal drug administartion of 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 5µg of dexmedetomidine in 1 ml volume.
干预措施: intrathecal drug administration (Procedure)
dexmedetomidine (I)
intrathecal drug administartion of 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 5µg of dexmedetomidine in 1 ml volume.
干预措施: Dexmedetomidine (Drug)
dexmedetomidine (I)
intrathecal drug administartion of 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 5µg of dexmedetomidine in 1 ml volume.
干预措施: Bupivacaine (Drug)
Dexmedetomidine + Ketamine group (III)
intrathecal drug administartion of patients in this arm received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 5µg of dexmedetomidine plus 0.1 mg/kg of Ketamine in 1 ml volume.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: the first 24 hours postoperative
efficacy of analgesia
次要结局
- time to first request of analgesia(the first 24 hours postoperative)
- total analgesic consumption(the first 24 hours postoperative)
- side effects(the first 24 hours postoperative)
研究者
Ahmad Mohammad Abd El-Rahman
Lecturer of anesthesia, intensive care, and pain management
Assiut University