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The Effect of Intraoperative Esmolol to Improve Postoperative Quality of Recovery and Pain After Ambulatory Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier:
NCT01782898
First received: January 31, 2013
Last updated: October 5, 2016
Last verified: October 2016
Results First Received: February 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Pain
Interventions: Drug: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min
Drug: Placebo Comparator: .9 normal saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Esmolol

Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min

Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min

.9 Normal Saline

.9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,

Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,


Participant Flow:   Overall Study
    Esmolol   .9 Normal Saline
STARTED   35   35 
COMPLETED   29   29 
NOT COMPLETED   6   6 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Esmolol

Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min

Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min

.9 Normal Saline

.9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,

Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,

Total Total of all reporting groups

Baseline Measures
   Esmolol   .9 Normal Saline   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   29   58 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   29   29   58 
>=65 years   0   0   0 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 38 
 (31 to 45) 
 41 
 (32 to 50) 
 39 
 (31 to 50) 
Gender 
[Units: Participants]
     
Female   29   29   58 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   29   29   58 
BMI (kg/m^2) [1] 
[Units: (kg/m^2)]
Median (Full Range)
 23 
 (22 to 29) 
 24 
 (23 to 26) 
 24 
 (22 to 29) 
[1]

BMI is the abbreviation for body mass index which is represented by the following:

(kg/m^2)

Intraoperative Fentanyl (mcg) 
[Units: Micrograms]
Median (Full Range)
 100 
 (50 to 150) 
 100 
 (50 to 150) 
 100 
 (50 to 150) 
Surgical Duration 
[Units: Minutes]
Median (Full Range)
 82 
 (67 to 99) 
 72 
 (66 to 83) 
 77 
 (67 to 99) 
American Society of Anesthesiologist Classification [1] 
[Units: Participants]
     
ASA Class 1   12   11   23 
ASA Class 2   17   18   35 
[1] The grading system is to evaluate the degree of a patient's physical state before undergoing anesthetic procedure. 1-6 1 being healthy patient and 6 being brain dead.


  Outcome Measures
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1.  Primary:   Qor-40 at 24 Hours Postoperative   [ Time Frame: 24 hours ]

2.  Secondary:   Postoperative Opioid Consumption   [ Time Frame: 24 hours ]

3.  Secondary:   Post Operative Pain Reported by the Subject.   [ Time Frame: 24 hour ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Gildasio De Oliveira, M.D.
Organization: Northwestern University
phone: 312-695-4858
e-mail: gjr@northwestern.edu



Responsible Party: Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier: NCT01782898     History of Changes
Other Study ID Numbers: STU00066623
Study First Received: January 31, 2013
Results First Received: February 4, 2016
Last Updated: October 5, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration