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Multimodal Analgesic Using Morphine and COX-2 With or Without Dexmedetomidine for Colorectal Surgery

NCT01353456 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-04-04

No results posted yet for this study

Summary

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.

Conditions

  • Pain, Postoperative

Interventions

DRUG

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.

DRUG

Normal Saline

Same volume as dexmedetomidine given

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-03-31
Completion
2010-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01353456 on ClinicalTrials.gov