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

NCT01353456 | Completed Phase 3

• 1 other identifier: 200907176018
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

Ambulation; Side effects; Serum sCD40L; Bowel function; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• Postoperative pain score as Numerical Rating Scale

  5 days

Secondary Outcomes (2)

• Number of patients having flatus and blow opening

  5 days

• Serum level of sCD40L

  3 days

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

Drug: Dexmedetomidine

Normal saline

PLACEBO COMPARATOR

Drug: Normal Saline

Interventions

Dexmedetomidine DRUG

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.

Dexmedetomidine

Normal Saline DRUG

Same volume as dexmedetomidine given

Normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hosspital

Hong Kong, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: May 4, 2011
• First Posted: May 13, 2011
• Study Start: May 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 4, 2013

Record last verified: 2013-04

Locations

CN (1)