Effect of Acute Arterial Hypertension on Morphine's Requirements and Postsurgical Pain.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Morphine requirement post laparoscopic cholecystectomy
研究概览
简要总结
The purpose of this randomized clinical trial is to evaluate the effect of acute arterial hypertension maintained during surgery on morphine's requirements in patients undergoing laparoscopic cholecystectomy
详细描述
The high arterial blood pressure has been correlated with an increase in pain threshold in animal and humans. One of the explanations to this phenomenon is a baroreceptor activity and vasopressin release at the level of spinal cord dorsal horn and hypothalamus.
As far as we know, there is only one study about the effect of chronic hypertension on postoperative pain and none with acute hypertension. We therefore decided to conduct a randomized controlled trial to evaluate the effect of acute hypertension on postoperative morphine's requirements.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •American Society of Anesthesiology patient classification status(ASA) I-II
- •Between 20 and 60 years of age
- •Programed for elective laparoscopic cholecystectomy
排除标准
- •History of arterial hypertension
- •Baseline blood pressure over 139/89
- •Use of opioids and any analgesic drug during the last 24 hours before surgery
- •Chronic use of nonsteroidal antiinflammatory
- •BMI > 34.9
- •History of drug or alcohol abuse
- •Use of medications that interfere in the central nervous system
- •Adverse reactions to the drugs used in the study
- •Pregnancy
研究组 & 干预措施
SBP 20-30% under baseline
Induction of anesthesia was performed with remifentanil, pentothal 3 mg/kg and atracurium 0.5 mg/Kg. Anaesthesia was maintained with remifentanil (0.4 ug/Kg/min) and isoflurane adjusted to bispectral index (40-60). Patients received a phenylephrine infusion to maintain systolic blood pressure (SBP) 20% to 30% under baseline. The lower limit of SBP was 75 mmHg. In the recovery room, morphine was administered routinely at doses of 3 mg IV every 15 minutes until pain was less than 4 estimated by visual analog scale (VAS). VAS and pain threshold with von Frey filaments were assessed at 2, 6, 12 and 24 postoperative hours. All patients, received ketorolac 30 mg IV every 8 hours and intravenous morphine administered by patient controlled analgesia system (PCA) during the first 24 hours.
干预措施: SBP 20-30% over baseline (Other)
SBP 20-30% over baseline
Induction of anesthesia was performed with remifentanil, pentothal 3 mg/kg and atracurium 0.5 mg/Kg. Anaesthesia was maintained with remifentanil (0.4 ug/Kg/min) and isoflurane adjusted to bispectral index(40-60). Patients received a phenylephrine infusion in order to maintain systolic blood pressure (SBP) 20% to 30% over baseline. The upper limit of SBP was 165 mmHg. In the recovery room, morphine was administered routinely at doses of 3 mg IV every 15 minutes until pain was less than 4 estimated by visual analog scale (VAS). VAS and pain threshold with von Frey filaments were assessed at 2, 6, 12 and 24 postoperative hours. All patients, received ketorolac 30 mg IV every 8 hours and intravenous morphine administered by patient controlled analgesia system (PCA) during the first 24 hours.
干预措施: SBP 20-30% under baseline (Other)
结局指标
主要结局
Morphine requirement post laparoscopic cholecystectomy
时间窗: First 24 hours postoperative
Measure of morphine consumption during the first 24 postoperative hours in patients undergoing laparoscopic cholecystectomy.
次要结局
- Effects of acute hypertension in pain scores(First 24 hours postoperative)