Labetalol and Esmolol: Vital Signs and Post Operative Pain Management

NCT01114971 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: Pro00019328
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laparoscopic Surgery

Keywords

Labetalol; Esmolol; Fentanyl; Anesthetic adjuvant; Ambulatory surgery; Outpatient surgery; Pain management; Hemodynamic stability; Perioperative outcomes

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain

  Postoperative pain will be measured at PACU using a Verbal Rating Scale (VRS) from 0 to 10 VRS is a subjective measure in which individuals verbally rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain)

  one day

Secondary Outcomes (5)

• Number of Participant With Opioid Consumption

  1 month

• Postoperative Nausea and Vomiting

  1 day

• Return to Feeling Normal

  1 month

• Patient Satisfaction Using a Verbal Rating Scale From 0 to 10

  1 month

• Low Appetite

  1 month

Study Arms (3)

Fentanyl

ACTIVE COMPARATOR

Fentanyl 50 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 Heart Rate (HR) \> 80 bpm)

Drug: Labetalol; Drug: Esmolol

Labetalol

EXPERIMENTAL

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)

Drug: Fentanyl; Drug: Esmolol

Esmolol

EXPERIMENTAL

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)

Drug: Fentanyl; Drug: Labetalol

Interventions

Fentanyl DRUG

Fentanyl 50 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)

Esmolol; Labetalol

Labetalol DRUG

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)

Esmolol; Fentanyl

Esmolol DRUG

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)

Also known as: Brevibloc

Fentanyl; Labetalol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to undergo outpatient surgery procedures
• Willingness and ability to sign an informed consent document
• No allergies to anesthetic or analgesic medications
• years of age
• American Society of Anesthesiologists (ASA) physical status classification 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Fentanyl; Labetalol; esmolol

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines

Results Point of Contact

• Title: Proffesor Paul F. White
• Organization: Cedars Sinai Medical Center

paul.white@cshs.org

2147703775

Study Officials

• Ronald H Wender, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Anesthesiology

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: May 3, 2010
• Study Start: September 3, 2009
• Primary Completion: July 30, 2014
• Study Completion: July 31, 2018
• Last Updated: February 20, 2020
• Results First Posted: February 20, 2020

Record last verified: 2020-02

Locations

US (1)