NCT01275911

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2011

Completed
Last Updated

March 27, 2013

Status Verified

March 1, 2013

Enrollment Period

1.5 years

First QC Date

January 12, 2011

Last Update Submit

March 25, 2013

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Amount of postoperative opioid consumption

    End of surgery- 24hr from the end of surgery

Secondary Outcomes (8)

  • Postoperative pain intensity

    every 24 hr from the end of surgery

  • Incidence of opioids side-effects

    during the duration of hospital stay

  • Length of stay in the PACU

    time spent in the recovery room

  • Length of stay in the hospital

    duration of hospitalization after the surgery

  • CHAMPS questionnaire

    preoperative, at 3 and 8 weeks after the surgery

  • +3 more secondary outcomes

Study Arms (2)

Esmolol

EXPERIMENTAL
Drug: Esmolol

Remifentanil

ACTIVE COMPARATOR
Drug: Remifentanil

Interventions

EsmololDRUG

Induction of anesthesia: 1mg/Kg; Maintenance during surgery: 5-15 mcg/kg/min

Esmolol
RemifentanilDRUG

At the induction of anesthesia: 1mcg/Kg; Maintenance during surgery: 0.025-0.25mcg/kg/min

Remifentanil

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age \<18 yr or \> 85 yr
  • ASA physical status 3 and greater
  • History of hepatic failure (Child \& Pug A-C)
  • Renal failure (creatinine outside the normal range)
  • Cardiac failure (NYHA I-IV)
  • Organ transplant
  • Diabetes mellitus type 1 and 2
  • Morbid obesity (BMI \> 40)
  • Chronic use of opioids and beta-blockers
  • Severe mental impairment
  • History of allergic reactions to all the medications used in the study or inability to understand pain assessment.
  • Asthma or Reactive airway disease
  • Patient with known or suspected peritoneal adhesion
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal General Hospital, McGill University Health Centre

Montreal, Quebec, H3G1A4, Canada

Location

Related Publications (8)

  • Collard V, Mistraletti G, Taqi A, Asenjo JF, Feldman LS, Fried GM, Carli F. Intraoperative esmolol infusion in the absence of opioids spares postoperative fentanyl in patients undergoing ambulatory laparoscopic cholecystectomy. Anesth Analg. 2007 Nov;105(5):1255-62, table of contents. doi: 10.1213/01.ane.0000282822.07437.02.

    PMID: 17959952RESULT

  • Coloma M, Chiu JW, White PF, Armbruster SC. The use of esmolol as an alternative to remifentanil during desflurane anesthesia for fast-track outpatient gynecologic laparoscopic surgery. Anesth Analg. 2001 Feb;92(2):352-7. doi: 10.1097/00000539-200102000-00014.

    PMID: 11159231RESULT

  • Johansen JW, Schneider G, Windsor AM, Sebel PS. Esmolol potentiates reduction of minimum alveolar isoflurane concentration by alfentanil. Anesth Analg. 1998 Sep;87(3):671-6. doi: 10.1097/00000539-199809000-00034.

    PMID: 9728851RESULT

  • White PF, Wang B, Tang J, Wender RH, Naruse R, Sloninsky A. The effect of intraoperative use of esmolol and nicardipine on recovery after ambulatory surgery. Anesth Analg. 2003 Dec;97(6):1633-1638. doi: 10.1213/01.ANE.0000085296.07006.BA.

    PMID: 14633533RESULT

  • Chia YY, Chan MH, Ko NH, Liu K. Role of beta-blockade in anaesthesia and postoperative pain management after hysterectomy. Br J Anaesth. 2004 Dec;93(6):799-805. doi: 10.1093/bja/aeh268. Epub 2004 Sep 17.

    PMID: 15377583RESULT

  • Erdil F, Demirbilek S, Begec Z, Ozturk E, But A, Ozcan Ersoy M. The effect of esmolol on the QTc interval during induction of anaesthesia in patients with coronary artery disease. Anaesthesia. 2009 Mar;64(3):246-50. doi: 10.1111/j.1365-2044.2008.05754.x.

    PMID: 19302635RESULT

  • Smith I, Van Hemelrijck J, White PF. Efficacy of esmolol versus alfentanil as a supplement to propofol-nitrous oxide anesthesia. Anesth Analg. 1991 Nov;73(5):540-6.

    PMID: 1683182RESULT

  • White PF. The role of non-opioid analgesic techniques in the management of pain after ambulatory surgery. Anesth Analg. 2002 Mar;94(3):577-85. doi: 10.1097/00000539-200203000-00019. No abstract available.

    PMID: 11867379RESULT

MeSH Terms

Conditions

Pain

Interventions

esmololRemifentanil

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Gabriele Baldini, MD

    McGill University Health Centre/Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc, Anesthesiologist, Assistant Professor

Study Record Dates

First Submitted

January 12, 2011

First Posted

January 13, 2011

Study Start

January 1, 2009

Primary Completion

July 1, 2010

Study Completion

August 1, 2010

Last Updated

March 27, 2013

Record last verified: 2013-03

Locations

CA(1)