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Esmolol Infusion During Laminectomy: Effect on Quality of Recovery

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ClinicalTrials.gov Identifier: NCT01179113
Recruitment Status : Terminated (The preliminary result didn't show any benefit.)
First Posted : August 11, 2010
Results First Posted : August 30, 2016
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider)
Condition Laminectomy
Interventions Drug: Esmolol
Drug: Saline
Enrollment 33
Recruitment Details Prior to the day of surgery, potential study patients scheduled to undergo spine surgical procedures received a packet of materials from their surgeon. The packet contained an initial patient contact letter, a privacy information sheet, and the institution review board (IRB)-approved informed consent form.
Pre-assignment Details  
Arm/Group Title Placebo Esmolol
Hide Arm/Group Description A normal saline bolus during induction, and an infusion of normal saline intraoperatively. Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
Period Title: Overall Study
Started 17 16
Completed 17 16
Not Completed 0 0
Arm/Group Title Placebo Esmolol Total
Hide Arm/Group Description A normal saline bolus during induction, and an infusion of normal saline intraoperatively. Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively Total of all reporting groups
Overall Number of Baseline Participants 17 16 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 16 participants 33 participants
59  (11) 54  (16) 57  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 33 participants
Female
8
  47.1%
7
  43.8%
15
  45.5%
Male
9
  52.9%
9
  56.3%
18
  54.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 16 participants 33 participants
17 16 33
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 17 participants 16 participants 33 participants
26  (5) 26  (4) 26  (5)
1.Primary Outcome
Title Post-operative Pain Using Verbal Rating Scale (VRS)
Hide Description

Verbal Rating Scale goes from 0 to 10, where:

0 indicates= No pain" and 10 indicates= The worst possible pain

The information was be recorded by study staff and data obtained from patient and patient charts from post-anesthesia care unit (PACU) stay

Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Esmolol
Hide Arm/Group Description:
A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
Overall Number of Participants Analyzed 17 16
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
4  (4) 5  (3)
2.Secondary Outcome
Title Opioid Consumption in PACU Obtained From the Recorded Data
Hide Description Postoperative use of opioid (Hydromorphone) consumption inside hospital at PACU (recorded by study staff and data obtained from patient charts).
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Esmolol
Hide Arm/Group Description:
A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
Overall Number of Participants Analyzed 17 16
Mean (Standard Deviation)
Unit of Measure: mg
1.5  (0.6) 2  (2.6)
3.Secondary Outcome
Title Postoperative Nausea and Vomiting
Hide Description Number of participants that experienced Postoperative nausea and vomiting using at PACU
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Esmolol
Hide Arm/Group Description:
A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
Overall Number of Participants Analyzed 17 16
Measure Type: Number
Unit of Measure: participants
2 0
Time Frame 1 day
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Esmolol
Hide Arm/Group Description A normal saline bolus during induction, and an infusion of normal saline intraoperatively. Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
All-Cause Mortality
Placebo Esmolol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Esmolol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/16 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Esmolol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/16 (0.00%) 
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: Dr. Roya Yumu', Anesthesiology Program Director
Organization: Cedars Sinai Medical Center
Phone: 310-423-1682
EMail: Roya.Yumul@cshs.org
Layout table for additonal information
Responsible Party: Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01179113    
Other Study ID Numbers: Pro00019850
First Submitted: August 10, 2010
First Posted: August 11, 2010
Results First Submitted: June 9, 2016
Results First Posted: August 30, 2016
Last Update Posted: November 2, 2016