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Labetalol and Esmolol: Vital Signs and Post Operative Pain Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01114971
Recruitment Status : Completed
First Posted : May 3, 2010
Results First Posted : February 20, 2020
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Ronald Wender, Cedars-Sinai Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Prevention
Condition Laparoscopic Surgery
Interventions Drug: Fentanyl
Drug: Labetalol
Drug: Esmolol
Enrollment 75
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fentanyl Labetalol Esmolol
Hide Arm/Group Description

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)

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)

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)

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)

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)

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)

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)

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)

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)
Period Title: Overall Study
Started 25 25 25
Completed 25 25 25
Not Completed 0 0 0
Arm/Group Title Fentanyl Labetalol Esmolol Total
Hide Arm/Group Description

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)

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)

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)

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)

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)

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)

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)

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)

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)
 Total of all reporting groups
Overall Number of Baseline Participants 25 25 25 75
Hide Baseline Analysis Population Description
ALL PARTICIPANTS = 75 PARTICIPANTS PER GROUP= 25
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 25 participants 75 participants
46  (13) 42  (14) 49  (11) 46  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 25 participants 75 participants
Female
21
  84.0%
21
  84.0%
15
  60.0%
57
  76.0%
Male
4
  16.0%
4
  16.0%
10
  40.0%
18
  24.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 25 participants 75 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
  12.0%
0
   0.0%
1
   4.0%
4
   5.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  12.0%
6
  24.0%
4
  16.0%
13
  17.3%
White
19
  76.0%
19
  76.0%
19
  76.0%
57
  76.0%
More than one race
0
   0.0%
0
   0.0%
1
   4.0%
1
   1.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Postoperative Pain
Hide Description 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)
Time Frame one day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fentanyl Labetalol Esmolol
Hide Arm/Group Description:

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)

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)

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)

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)

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)

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)

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)

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)

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)
Overall Number of Participants Analyzed 25 25 25
Mean (Standard Deviation)
Unit of Measure: Score on scale 0-10
3.2  (2) 3  (3) 3.9  (2.5)
2.Secondary Outcome
Title Number of Participant With Opioid Consumption
Hide Description n=Post discharge use of opioid consumption NUMBER OF PARTICIPANTS WHO TOOK PAIN KILLER PILLS
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fentanyl Labetalol Esmolol
Hide Arm/Group Description:

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)

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)

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)

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)

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)

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)

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)

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)

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)
Overall Number of Participants Analyzed 25 25 25
Measure Type: Number
Unit of Measure: participants
15 14 13
3.Secondary Outcome
Title Postoperative Nausea and Vomiting
Hide Description Nausea and vomiting will be measured at PACU
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fentanyl Labetalol Esmolol
Hide Arm/Group Description:

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)

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)

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)

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)

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)

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)

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)

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)

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)
Overall Number of Participants Analyzed 25 25 25
Measure Type: Number
Unit of Measure: participants
9 4 7
4.Secondary Outcome
Title Return to Feeling Normal
Hide Description Days to report to return to feeling normal, using follow up questionnaires
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fentanyl Labetalol Esmolol
Hide Arm/Group Description:

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)

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)

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)

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)

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)

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)

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)

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)

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)
Overall Number of Participants Analyzed 25 25 25
Mean (Standard Deviation)
Unit of Measure: Days
11  (9) 10  (9) 12  (10)
5.Secondary Outcome
Title Patient Satisfaction Using a Verbal Rating Scale From 0 to 10
Hide Description Patient satisfaction using a verbal rating scale from 0 to 10 Where a VRS is a subjective measure in which individuals verbally rated their level of satisfaction on an eleven-point numerical scale. The scale is composed of 0 (excellent satisfaction) to 10
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fentanyl Labetalol Esmolol
Hide Arm/Group Description:

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)

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)

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)

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)

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)

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)

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)

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)

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)
Overall Number of Participants Analyzed 25 25 25
Mean (Standard Deviation)
Unit of Measure: score on a scale (0-10)
9.1  (1.6) 9  (1.2) 8  (2.5)
6.Secondary Outcome
Title Low Appetite
Hide Description Participant who experienced low appetite (follow up questionnaire)
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fentanyl Labetalol Esmolol
Hide Arm/Group Description:

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)

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)

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)

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)

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)

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)

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)

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)

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)
Overall Number of Participants Analyzed 25 25 25
Measure Type: Number
Unit of Measure: participants
15 7 9
Time Frame One month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fentanyl Labetalol Esmolol
Hide Arm/Group Description

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)

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)

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)

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)

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)

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)

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)

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)

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)
All-Cause Mortality
Fentanyl Labetalol Esmolol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%)   0/25 (0.00%) 
Hide Serious Adverse Events
Fentanyl Labetalol Esmolol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%)   0/25 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fentanyl Labetalol Esmolol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%)   0/25 (0.00%) 
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Proffesor Paul F. White
Organization: Cedars Sinai Medical Center
Phone: 2147703775
EMail: paul.white@cshs.org
Layout table for additonal information
Responsible Party: Ronald Wender, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01114971    
Other Study ID Numbers: Pro00019328
First Submitted: April 23, 2010
First Posted: May 3, 2010
Results First Submitted: November 22, 2019
Results First Posted: February 20, 2020
Last Update Posted: February 20, 2020