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Labetalol and Esmolol: Vital Signs and Post Operative Pain Management

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Cedars-Sinai Medical Center
Sponsor:
Information provided by (Responsible Party):
Ronald Wender, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01114971
First received: April 23, 2010
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

This study proposes to investigate the effects of labetalol or esmolol on managing the vital signs (like blood pressure and heart rate) during surgery, on pain management, and on the later recovery after surgery.

It will also assess the cost-effectiveness of Labetalol and esmolol for outpatient surgery.


Condition Intervention Phase
Ambulatory Surgical Procedures
Drug: Fentanyl
Drug: Labetalol
Drug: Esmolol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: Randomized, Double-Blinded, Active-Controlled Study to Evaluate the Intraoperative Use of Labetalol vs. Esmolol for Maintaining Hemodynamic Stability During Ambulatory Surgery: Effect on Recovery and Postoperative Pain

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Postoperative pain using a Verbal Rating Scale [ Time Frame: one month ] [ Designated as safety issue: No ]
    Postoperative will be measured at PACA and 30 days after surgery


Secondary Outcome Measures:
  • Opioid consumption obtained from the recorded data [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts) Post discharge use of opioid consumption (data obtained from the follow up questionnaires at 30 days after surgery)

  • Postoperative nausea and vomiting using a Verbal Rating Scale [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Nausea and vomiting will be measured at PACU and with a follow up questionnaires 30 days after surgery

  • Return to normal activities of daily living using follow up questionnaires [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Return to normal activities of daily living(including dietary intake, bowel and bladder function, physical activities)will be measured in both groups.

  • Patient satisfaction using a verbal rating scale from 0 to 100 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    0= Not satisfied 100= Excellent

  • Hospital stay [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fentanyl Drug: Fentanyl

Fentanyl 20 micrograms/ml boluses will be given:

  • at the induction time
  • at the time before surgical incision, and
  • as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
Other Name: Fentanyl
Labetalol Drug: Labetalol

Labetalol 5 mg/ml boluses will be given:

  • at the induction time
  • at the time before surgical incision, and
  • as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
Other Name: Labetalol
Esmolol Drug: Esmolol

Esmolol 10 mg/ml boluses will be given:

  • at the induction time
  • at the time before surgical incision, and
  • as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
Other Name: Brevibloc

Detailed Description:

Finding the optimal combination of anesthetic adjuvant drugs for maintaining hemodynamic stability during surgery is a challenge (1-3). Traditionally, potent opioid analgesics like fentanyl and its newer analogs have been used for this purpose. However, use of opioid compounds is associated with well-known side effects (e.g., ventilatory depression, postoperative nausea and vomiting, constipation, ileus, bladder dysfunction, urinary retention, pruritus, drowsiness and sedation). All of these common side effects interfere with the early recovery process and contribute to a delayed resumption of normal activities (4, 5). Increasingly, non-opioid analgesics (e.g. β-blockers and local anesthetics) are being utilized as adjuvant drugs during surgery for treatment of acute hyperdynamic responses (increased catecholamine release) during surgery, as well as, facilitation of the recovery process after surgery because of their anesthetic and analgesic-sparing effects. The β-blocking drugs, esmolol and labetalol have been used as an alternative to short-acting opioid analgesics for controlling the transient, acute autonomic responses during surgery (5-8), They have been shown to reduce the anesthetic requirement during intravenous (propofol) or volatile-based anesthesia (6,7,10-13) and to decrease opioid consumption intraoperatively and in the PACU (8). They may also improve hemodynamic stability during induction and emergence from anesthesia in the perioperative and early postoperative period and facilitate the resumption of normal activities after major surgical procedures. The anesthetic and analgesic-sparing effects of β -blockers also lead to a faster emergence from anesthesia and reduce postoperative opioid side effects (e.g., PONV) (14-18). Perioperative intravenous esmolol has shown improvement in perioperative outcomes, decreases acute hemodynamic responses, reduces anesthetics and opioids use during anesthesia, facilitates a faster emergence from anesthesia, reduces intraoperative and postoperative opioid requirements, reduces side effects as such as pruritus, constipation, ileus, nausea and vomiting (PONV) and thereby shortens the hospital stay. (3, 7, 13, 18)

Local anesthetics like lidocaine possess analgesic, antihyperalgesic and anti-inflammatory properties. Perioperative intravenous lidocaine has shown improvement in perioperative outcomes in patients undergoing abdominal surgery to decrease intraoperative requirement of Inhalants/Intravenous agents, opioid consumption, postoperative pain, fatigue, nausea and vomiting scores, maintain hemodynamic stability, facilitate a more rapid recovery of gastrointestinal function, improve postoperative recovery, fast resumption of normal activities of daily living and shorten length of hospital stay, when administered as an adjuvant during surgery.(19,23-29,33)

Theoretically, it would be extremely beneficial to administer an adjuvant (to patients undergoing abdominal surgery) that is capable of effectively controlling autonomic responses during surgery, while providing a faster recovery with fewer side effects. Preliminary data suggests that the perioperative effects of systemic administration of lidocaine and esmolol is most effective in facilitating bowel recovery, decreasing opioid consumption in the intra/postoperative period, and shorten length of hospital stay with early recovery. Therefore, we designed this prospective, randomized, double-blinded, active-controlled study to test the hypothesis that systemic administration of lidocaine and esmolol in combination (vs. either drug alone) for maintenance of hemodynamic stability during surgery will result in improved postoperative outcomes for patients undergoing abdominal surgery (e.g., less pain and postoperative nausea and vomiting, and faster return of bowel function and resumption of normal activities of daily living); leading to a shorten length of hospital stay.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled to undergo outpatient surgery procedures
  • Willingness and ability to sign an informed consent document
  • No allergies to anesthetic or analgesic medications
  • 18 - 80 years of age
  • ASA Class I - III adults of either sex
  • Women of childbearing potential must be currently practicing an acceptable form of birth control, and have a negative urine pregnancy test

Exclusion Criteria:

  • Patients with known allergy, hypersensitivity or contraindications to anesthetic or analgesic medications
  • Patients with clinically-significant medical conditions, such as brain, heart, kidney, endocrine, or liver diseases, peptic ulcer disease or bleeding disorders
  • Pregnant or lactating women
  • Subjects with a history of alcohol or drug abuse within the past 3 months
  • Any other conditions or use of any medication which may interfere with the conduct of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114971

Contacts
Contact: Paul F White, MD, PhD (214)648-6424 paul.white@utsouthwestern.edu
Contact: Ofelia L Elvir-Lazo, MD (310) 423-4414 loanidoc@yahoo.com

Locations
United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Ronald H Wender, MD    310-423-5841    Ronald.Wender@cshs.org   
Contact: Ofelia L Elvir-Lazo, MD    310-423-4414    loanidoc@yahoo.com   
Sub-Investigator: Roya Yumul, Md, PhD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Ronald H Wender, MD Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Ronald Wender, Chairman, Department of Anesthesiology, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01114971     History of Changes
Other Study ID Numbers: Pro00019328
Study First Received: April 23, 2010
Last Updated: October 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Labetalol
Esmolol
Fentanyl
Anesthetic adjuvant
Ambulatory surgery
Outpatient surgery
Pain management
Hemodynamic stability
Perioperative outcomes

Additional relevant MeSH terms:
Esmolol
Fentanyl
Labetalol
Adjuvants, Anesthesia
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Narcotics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014