Non-opioid Analgesia for Fast-track Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gabriele Baldini, MD, MSc, Assistant Professor, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01275911
First received: January 12, 2011
Last updated: March 25, 2013
Last verified: March 2013
  Purpose

In this randomized observer-blinded trial the analgesic efficacy of intravenous esmolol, as alternative to intraoperative opioids, is tested in patients undergoing laparoscopic prostatectomy and upper gastrointestinal surgery (such as Nissen fundoplication). The purpose of this study is to determine whether intravenous esmolol improves postoperative analgesia and accelerate the surgical recovery. We hypothesize that patients receiving intravenous esmolol will consume less analgesic in the postoperative period, will have less opioid-related side effects and will recover their functional status faster then patients receiving intravenous esmolol.

Patients will be stratified according to the type of surgical procedure in 2 arms: 40 patients with prostate cancer and undergoing elective laparoscopic prostatectomy, and 40 patients with gastro-esophageal reflux undergoing upper gastrointestinal surgery (Nissen funduplication) will be enrolled.

Patients will receive total intravenous anesthesia with propofol and esmolol (Esmolol group, n=20 in each arm) or propofol and remifentanil (Remifentanil Group, n=20 in each arm).


Condition Intervention
Pain
Drug: Esmolol
Drug: Remifentanil

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fast-track Laparoscopic Surgery. The Effect of Anesthetic Technique

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Amount of postoperative opioid consumption [ Time Frame: End of surgery- 24hr from the end of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative pain intensity [ Time Frame: every 24 hr from the end of surgery ] [ Designated as safety issue: No ]
  • Incidence of opioids side-effects [ Time Frame: during the duration of hospital stay ] [ Designated as safety issue: No ]
  • Length of stay in the PACU [ Time Frame: time spent in the recovery room ] [ Designated as safety issue: No ]
  • Length of stay in the hospital [ Time Frame: duration of hospitalization after the surgery ] [ Designated as safety issue: No ]
  • CHAMPS questionnaire [ Time Frame: preoperative, at 3 and 8 weeks after the surgery ] [ Designated as safety issue: No ]
  • short-term SF-36 [ Time Frame: preoperative, at 3 and 8 weeks after the surgery ] [ Designated as safety issue: No ]
  • 2 minutes walking test [ Time Frame: preoperative, at 4 weeks after the surgery ] [ Designated as safety issue: No ]
  • 6 minutes walking test [ Time Frame: preoperative, at 4 weeks after the surgery ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2009
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Esmolol Drug: Esmolol
Induction of anesthesia: 1mg/Kg; Maintenance during surgery: 5-15 mcg/kg/min
Active Comparator: Remifentanil Drug: Remifentanil
At the induction of anesthesia: 1mcg/Kg; Maintenance during surgery: 0.025-0.25mcg/kg/min

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with prostate cancer undergoing laparoscopic prostatectomy
  2. Patients with gastro-esophageal reflux undergoing upper abdominal surgery (Nissen funduplication)

Exclusion Criteria:

  1. Age <18 yr or > 85 yr
  2. ASA physical status 3 and greater
  3. History of hepatic failure (Child & Pug A-C)
  4. Renal failure (creatinine outside the normal range)
  5. Cardiac failure (NYHA I-IV)
  6. Organ transplant
  7. Diabetes mellitus type 1 and 2
  8. Morbid obesity (BMI > 40)
  9. Chronic use of opioids and beta-blockers
  10. Severe mental impairment
  11. History of allergic reactions to all the medications used in the study or inability to understand pain assessment.
  12. Asthma or Reactive airway disease
  13. Patient with known or suspected peritoneal adhesion
  14. Pregnancy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01275911

Locations
Canada, Quebec
Montreal General Hospital, McGill University Health Centre
Montreal, Quebec, Canada, H3G1A4
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Gabriele Baldini, MD McGill University Health Center
  More Information

Publications:

Responsible Party: Gabriele Baldini, MD, MSc, Assistant Professor, MD, MSc, Anesthesiologist, Assistant Professor, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01275911     History of Changes
Other Study ID Numbers: GEN#08-22
Study First Received: January 12, 2011
Last Updated: March 25, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Esmolol
Remifentanil
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on August 27, 2014