Multimodal Analgesic Using Morphine and COX-2 With or Without Dexmedetomidine for Colorectal Surgery
|ClinicalTrials.gov Identifier: NCT01353456|
Recruitment Status : Completed
First Posted : May 13, 2011
Last Update Posted : April 4, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Drug: Dexmedetomidine Drug: Normal Saline||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Multimodal Analgesic Using Morphine and COX-2 With or Without Dexmedetomidine for Colorectal Surgery|
|Study Start Date :||May 2008|
|Primary Completion Date :||March 2010|
|Study Completion Date :||September 2010|
|Active Comparator: Dexmedetomidine||
Patient will receive a loading dose of 1μg/kg (0.25ml/kg) intravenous dexmedetomidine over 10 minutes before induction, and then followed by continuous infusion at a rate of 0.5μg/kg/h (0.125ml/kg/h) until wound closure.
|Placebo Comparator: Normal saline||
Drug: Normal Saline
Same volume as dexmedetomidine given
- Postoperative pain score as Numerical Rating Scale [ Time Frame: 5 days ]
- Number of patients having flatus and blow opening [ Time Frame: 5 days ]
- Serum level of sCD40L [ Time Frame: 3 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353456
|Queen Mary Hosspital|
|Hong Kong, China|