Labetalol and Esmolol: Vital Signs and Post Operative Pain Management

NCT01114971 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2020-02-20

Study results available
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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

Interventions

DRUG

Fentanyl

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)

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)

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)

Sponsors & Collaborators

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Ronald H Wender, MD · Cedars-Sinai Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-03
Primary Completion
2014-07-30
Completion
2018-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01114971 on ClinicalTrials.gov