Non-opioid Analgesia for Fast-track 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: NCT01275911
Recruitment Status : Completed
First Posted : January 13, 2011
Last Update Posted : March 27, 2013
Information provided by (Responsible Party):
Gabriele Baldini, MD, MSc, Assistant Professor, McGill University Health Center

Brief Summary:

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 or disease Intervention/treatment Phase
Pain Drug: Esmolol Drug: Remifentanil Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fast-track Laparoscopic Surgery. The Effect of Anesthetic Technique
Study Start Date : January 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Amount of postoperative opioid consumption [ Time Frame: End of surgery- 24hr from the end of surgery ]

Secondary Outcome Measures :
  1. Postoperative pain intensity [ Time Frame: every 24 hr from the end of surgery ]
  2. Incidence of opioids side-effects [ Time Frame: during the duration of hospital stay ]
  3. Length of stay in the PACU [ Time Frame: time spent in the recovery room ]
  4. Length of stay in the hospital [ Time Frame: duration of hospitalization after the surgery ]
  5. CHAMPS questionnaire [ Time Frame: preoperative, at 3 and 8 weeks after the surgery ]
  6. short-term SF-36 [ Time Frame: preoperative, at 3 and 8 weeks after the surgery ]
  7. 2 minutes walking test [ Time Frame: preoperative, at 4 weeks after the surgery ]
  8. 6 minutes walking test [ Time Frame: preoperative, at 4 weeks after the surgery ]

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT01275911

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

Publications of Results:

Responsible Party: Gabriele Baldini, MD, MSc, Assistant Professor, MD, MSc, Anesthesiologist, Assistant Professor, McGill University Health Center Identifier: NCT01275911     History of Changes
Other Study ID Numbers: GEN#08-22
First Posted: January 13, 2011    Key Record Dates
Last Update Posted: March 27, 2013
Last Verified: March 2013

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