Intraoperative and Postoperative Effects of Adjuvant Dexmedetomidine and Tramadol in Subcostal Transversus Abdominis Plan Block
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- intraoperative non invasive blood pressure
研究概览
简要总结
In this study, dexmedetomidine and tramadol were added as adjuvant to bupivacaine in transversus abdominis plane block (TAP), intraoperative hemodynamics, opioid consumption, muscle relaxant use, postoperative analgesic effects and side effects (such as nausea-vomiting) were evaluated.
详细描述
The study was carried out with 60 ASA I-II class participants aged 20-60 years who underwent laparoscopic cholecystectomy at Van Yuzuncu Yıl University Faculty of Medicine. Preoperative evaluation was made before the operation, routine laboratory analyzes were taken, the participants were informed about the study, and their written consent was obtained. Participants were randomized into two groups.
- Group T (Adjuvant Tramadol): 40 mL of 0.250% bupivacaine + 1.5mg/kg and a maximum of 100 mg tramadol adjuvant
- Group D (Adjuvant Dexmedetomidine): 40 mL of 0.250% bupivacaine + 0.5 mcg/kg and a maximum of 50 mcg dexmedetomidine adjuvant Standard general anesthesia was applied. After intubation, bilateral subcostal TAP block was performed by the same anesthesiologist, demographic data were recorded. Intraoperative vital signs of the participants (pulse, non-invasive blood pressure and peripheral oxygen saturation measurement), additional opioid and muscle relaxant needs, and complications were recorded. Extubation was performed after standard decurarization with atropine and neostigmine. Postoperative side effects (nausea, vomiting, pruritus, shivering), postoperative additional analgesic need, and 0 hour (Modified aldrete score ≥9 time was accepted as 0 hour), 3rd hour and 6th hour Visual Analogue Scale (VAS) scores were evaluated and recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20-60 years old
- •Those who will undergo elective laparoscopic cholecystectomy surgery
- •Those in ASA I-II physical status
- •Those who gave consent to participate in the study
排除标准
- •Those outside the age range of 20-60
- •Those outside of ASA I-II physical status
- •Serious heart, lung, liver disease
- •Kidney failure
- •Bleeding diathesis
- •Those who develop complications during the procedure
- •Those with fever, active infection
- •Those who are allergic to the drugs to be used
- •Those who refused to participate in the study
- •Those with hypothermic and acid-base disorders
- •Electrolyte disturbances such as hypokalemia, hypocalcemia
- •Those taking antibiotics, anticonvulsants, antiarrhythmics, cholinesterase inhibitors
- •Those with bleeding
- •BMI 30 and above
研究组 & 干预措施
Group T
Group T (Adjuvant tramadol): Bilateral subcostal TAP block was performed using solutions prepared by adding 0.250% bupivacaine + 40 mL adjuvant 1.5mg/kg (maximum 100 mg) tramadol.
Systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), HR, SpO2 values were recorded.
Demographic data of the patients [age, weight, height, body mass index (BMI), smoking use] and operation times were recorded.
All patients were administered 1000 mg parol IV as standard analgesic before extubation.
The patients were followed up for side effects (such as nausea-vomiting, chills, itching and desaturation) including drug allergies.The patients were evaluated at 0, 3 and 6 hours after the operation with a 0-10 verbal rating scale visual analog scale (VAS) and the data were recorded. In all groups, VAS˃ 4 value was evaluated in favor of analgesic need and 50 mg Dexketoprofen IV bolus was administered in accordance with conventional treatment.
干预措施: Tramadol + Bupivacaine (Drug)
Group D
Group D (adjuvant dexmedetomidine): Bilateral subcostal TAP block was performed using solutions prepared by adding 0.250% bupivacaine + 0.5 mcg/kg and (maximum 50 mcg) dexmedetomidine.
All patients were administered 1000 mg parol IV as standard analgesic before extubation.
The patients were followed up for side effects (such as nausea-vomiting, chills, itching and desaturation) including drug allergies.
The patients were evaluated at 0, 3 and 6 hours after the operation with a 0-10 verbal rating scale visual analog scale (VAS) and the data were recorded. VAS 0-2: no pain, 3-4: mild pain, 5-6: moderate pain, 7-8: severe pain, 9-10: excruciating pain. Additional analgesic requirement in the postoperative period was calculated by measuring VAS>4 values. In all groups, VAS˃ 4 value was evaluated in favor of analgesic need and 50 mg Dexketoprofen IV bolus was administered in accordance with conventional treatment.
干预措施: Dexmedetomidin + bupivacaine (Procedure)
结局指标
主要结局
intraoperative non invasive blood pressure
时间窗: 10 minutes
non invasive blood pressure(systolic, diastolic and mean blood pressure)
intraoperative opioid consumption
时间窗: 40 minutes
The necessary opioid (mcg) addiction was noted
intraoperative heart rate
时间窗: 5 minutes
Heart rate was noted
intraoperative muscle relaxant use
时间窗: 40 minutes
The necessary muscle relaxant (mg) addiction was noted
次要结局
- Number of participants with postoperative side effects(0., 3., 6. hour measurements were evaluated)
- postoperative analgesic effects(0., 3., 6. hour measurements were evaluated)
研究者
Arzu Esen Tekeli
Associate Professor
Yuzuncu Yıl University