CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 75 enrolled
Drug / intervention
Fentanyl +2 moredrug
Likely dose
Fentanyl 50 microgramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01114971
NCT01114971Phase 4Completed
CompareCT.gov

Randomized, Double-Blinded, Active-Controlled Study to Evaluate the Intraoperative Use of Labetalol vs. Esmolol for Maintaining Hemodynamic Stability During Laparoscopic Surgery: Effect on Recovery and Postoperative Pain

Cedars-Sinai Medical Center·interventional·Posted May 3, 2010·Updated Feb 20, 2020

In Brief

A Phase 4 clinical trial evaluating Fentanyl, Labetalol, and 1 other intervention for Laparoscopic Surgery. Completed, enrolled 75 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLaparoscopic Surgery
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 3, 2010
Enrollment StartSep 3, 2009
Primary CompletionJul 30, 2014
Study CompletionJul 31, 2018
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 16.2 years ago

Interventions

Fentanyldrug

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)

Labetaloldrug

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)

Esmololdrug

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)