Multimodal Analgesic Using Morphine and COX-2 With or Without Dexmedetomidine for Colorectal Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative pain score as Numerical Rating Scale
研究概览
简要总结
Recently, multimodal approach for postoperative pain control has been advocated.Combinations of traditional and novel pharmacological agents are administered, aiming to improve analgesia, spare opioid consumption, minimise adverse effects, and improve postoperative bowel function in colorectal surgery.
One of the novel agents suggested is dexmedetomidine. It is a selective alpha-2 adrenoceptor agonist, which has been demonstrated to have anaesthetic, sedative and analgesic-sparing effects. Furthermore, a significant reduction in postoperative morphine consumption by using patient-controlled analgesia (PCA) has been achieved when dexmedetomidine was administered before operation. The drug also reduces cate-cholamine secretion, thereby reducing stress and leading to a modest reduction in heart rate and blood pressure, which may be particularly beneficial in patients with cardiovascular disease, while respiratory rate is not affected.
In this study, the investigators would like to evaluate the analgesic effects of dexmedetomidine, which is administered intraoperatively with morphine, followed by postoperative PCA morphine infusion, for postoperative pain for open and laparoscopic colorectal surgery. Cyclooxy-genase-2 (COX-2) inhibitors and rescue intramuscular pethidine will also be incorporated as part of the multimodal analgesia regimens.
Good pain control can help to decrease cardiovascular complications. Emerging data has suggested a key role of soluble CD40L as inflammatory mediators of atherosclerotic lesion progression. The investigators would like to evaluate the effect of our analgesic regimens on soluble CD40L peri-operatively.
The investigators hypothesize that intraoperative dexmedetomidine can reduce postoperative pain and improve recovery and outcomes.
详细描述
PROCEDURES:
Patients will be approached at the pre-admission clinic or in the general ward before operation. The analgesic modalities will be explained and patient will be recruited into study if s/he agrees. Patient will then be randomised into one of the two groups receiving intraoperative morphine with dexmedetomidine then postoperative PCA morphine (D), or intraoperative morphine only then postoperative PCA morphine (M).
Randomisation, blinding, and preparation of dexmedetomidine and placebo Patients who undergo open and laparoscopic colonic and rectal surgery will be stratified in randomisation. For each type of operation (colonic and rectal), randomisation will be based on using blocks of 5 patients to ensure both groups having equal sample size. A computer-generated random sequence will be used to select the allocation order.
Both patients and investigators will be blinded to the allocated analgesic modalities, i.e. the administration of dexmedetomidine. Dexmedetomidine or normal saline (placebo) will be prepared by clinical staff who will not participate in observation and data analysis.
For group D, dexmedetomidine will be prepared by adding 2ml of the drug (100μg/ml) to 48ml of 0.9% sodium chloride injection, which make up to a total of 50ml. The final concentration for administration is thus 200μg in 50ml, i.e. 4μg/ml.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •ASA I to III
- •Age 18 to 80 years
- •Scheduled for elective open and laparoscopic colonic or upper rectal resection in Queen Mary Hospital in Hong Kong
排除标准
- •Extended resection involving other organs such as liver and urinary bladder
- •Known drug allergy to alpha-2 agonists, opioids, non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2 inhibitors or sulphonamides
- •Regular use of clonidine, methyldopa, opioids or psychiatric drugs
- •Alcohol or drug abuse
- •Known history of second or third degree heart block, ischaemic heart disease, valvular heart disease, or heart failure
- •Known history of pulmonary embolism or deep vein thrombosis
- •Known history of sleep apnoea syndrome
- •Impaired renal function, defined as preoperative serum creatinine level over 120µmol/L
- •Impaired hepatic function, defined as preoperative serum albumin level less than 30g/L
- •Impaired or retarded mental state
- •Not self-ambulatory before operation
- •Difficulties in using patient-controlled analgesia
- •BMI > 35kg/m2
- •Pregnancy
- •Patient refusal
研究组 & 干预措施
Dexmedetomidine
干预措施: Dexmedetomidine (Drug)
Normal saline
干预措施: Normal Saline (Drug)
结局指标
主要结局
Postoperative pain score as Numerical Rating Scale
时间窗: 5 days
次要结局
- Number of patients having flatus and blow opening(5 days)
- Serum level of sCD40L(3 days)
研究者
Cheung Chi Wai
Clinical Associate Professor
The University of Hong Kong