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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier:
NCT01782898
First received: January 31, 2013
Last updated: November 18, 2014
Last verified: November 2014

January 31, 2013
November 18, 2014
January 2013
December 2015   (final data collection date for primary outcome measure)
Qor-40 at 24 hours postoperative [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Quality of recovery questionnaire score at 24 hours after surgery.
Same as current
Complete list of historical versions of study NCT01782898 on ClinicalTrials.gov Archive Site
  • Postoperative opioid consumption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The total amount of opioid consumed by subject at 24 hours after surgery.
  • Post operative pain reported by the subject. [ Time Frame: 24 hour ] [ Designated as safety issue: No ]
    Post operative pain reported by the subject.
  • Postoperative pain sensitivity and threshold [ Time Frame: Postoperative ] [ Designated as safety issue: No ]
    Postoperative pain sensitivity and threshold determined by Pathway Pain & sensory evaluation system (Medoc, Dunham, NC).
Same as current
Not Provided
Not Provided
 
The Effect of Intraoperative Esmolol to Improve Postoperative Quality of Recovery and Pain After Ambulatory Surgery
The Effect of Intraoperative Esmolol to Improve Postoperative Quality of Recovery and Pain After Ambulatory Surgery

Seventy percent of surgeries performed in the United States are done in an outpatient setting.Pain Control after ambulatory surgery is very challenging because patients do not have access to fast and potent intravenous medications Pain after ambulatory surgery is poorly controlled in the United States with up to seventy five percent of patients having moderate to severe pain after ambulatory procedures. Postoperative pain have been associated with serious morbidity, including myocardial infarction and pulmonary embolism.

The use of intraoperative opioids can result in an exaggerated response to pain (hyperalgesia) and contribute to an exacerbation of pain after surgical procedures.Opioids are commonly given intraoperative, not in response to pain, but in response to hyperdynamic cardiovascular states. Esmolol is a short acting beta 1 antagonist that can be used to treat/prevent hyperdynamic states during surgery. More importantly, esmolol has been shown to have central antihyperalgesic effects that might contribute to a reduction in postoperative pain. It is therefore conceivable that the use of intraoperative esmolol instead of opioids to avoid hyperdynamic states during surgery can result in lower postoperative pain. Since postoperative pain can substantially affect postoperative quality of recovery, it is also conceivable that the use of intraoperative esmolol might result in an improved postoperative quality of recovery to surgical patients.

The main objective of the current study is to examine the effect of intraoperative esmolol on postoperative quality of recovery. A secondary objective is to examine the effect of esmolol on postoperative pain.

Significance: Postoperative pain after ambulatory surgery has been shown to be poorly managed in The United States. The goal of this study is to investigate if a change in the intraoperative pharmacologic management of patients undergoing ambulatory surgery can improve their postoperative quality of recovery and pain.

The research question is; does the use of intraoperative esmolol improve postoperative quality of recovery after ambulatory surgery? Does the use of intraoperative esmolol improve postoperative pain after ambulatory surgery?

The hypotheses of this study is; does the use of intraoperative esmolol improves postoperative quality of recovery after ambulatory surgery. The use of intraoperative esmolol reduces postoperative pain after ambulatory surgery.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Pain
  • Drug: 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
    Other Name: Esmolol
  • Drug: 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,
    Other Name: Normal Saline
  • Active Comparator: Esmolol
    Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min
    Intervention: Drug: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min
  • Placebo Comparator: .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,
    Intervention: Drug: Placebo Comparator: .9 normal saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

- Female patients Undergoing outpatient hysteroscopic myomectomy surgery ASA PS I and II Age between 18 and 64 years Fluent in English

Exclusion Criteria:

History of allergy to beta-blocker History of chronic opioid use Pregnant patients BMI greater than 35 History of EKG abnormalities or cardiac arrhythmias Beta-blocker medication usage.

Dropout criteria: Patient or surgeon request, Conversion of the surgery from laparoscopic to open.

Female
18 Years to 64 Years
No
Contact: Gildasio De Oliveira, MD (312)472-3585 gjr@northwestern.edu
United States
 
NCT01782898
STU00066623
No
Gildasio De Oliveira, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Gildasio De Oliveira, MD Northwestern University
Northwestern University
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP