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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cheung Chi Wai, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01353456
First received: May 4, 2011
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Pain, Postoperative
Drug: Dexmedetomidine
Drug: Normal Saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multimodal Analgesic Using Morphine and COX-2 With or Without Dexmedetomidine for Colorectal Surgery

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Postoperative pain score as Numerical Rating Scale [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients having flatus and blow opening [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Serum level of sCD40L [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: May 2008
Study Completion Date: September 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01353456

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

No publications provided

Responsible Party: Cheung Chi Wai, Clinical Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01353456     History of Changes
Other Study ID Numbers: 200907176018
Study First Received: May 4, 2011
Last Updated: April 2, 2013
Health Authority: Hong Kong: Institutional Review Board

Keywords provided by The University of Hong Kong:
Ambulation
Side effects
Serum sCD40L
Bowel function
Postoperative pain

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

ClinicalTrials.gov processed this record on September 16, 2014