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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01353456
Recruitment Status : Completed
First Posted : May 13, 2011
Last Update Posted : April 4, 2013
Information provided by (Responsible Party):
Cheung Chi Wai, The University of Hong Kong

Brief 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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Dexmedetomidine 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.
Placebo Comparator: Normal saline Drug: Normal Saline
Same volume as dexmedetomidine given

Primary Outcome Measures :
  1. Postoperative pain score as Numerical Rating Scale [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. Number of patients having flatus and blow opening [ Time Frame: 5 days ]
  2. Serum level of sCD40L [ Time Frame: 3 days ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01353456

Queen Mary Hosspital
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong

Responsible Party: Cheung Chi Wai, Clinical Associate Professor, The University of Hong Kong Identifier: NCT01353456     History of Changes
Other Study ID Numbers: 200907176018
First Posted: May 13, 2011    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: April 2013

Keywords provided by Cheung Chi Wai, The University of Hong Kong:
Side effects
Serum sCD40L
Bowel function
Postoperative pain

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action