The Effect of Intraoperative Esmolol to Improve Postoperative Quality of Recovery and Pain After Ambulatory Surgery
Information source: Northwestern University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: 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 (Drug)
Phase: N/A
Status: Completed
Sponsored by: Northwestern University Official(s) and/or principal investigator(s): Gildasio De Oliveira, MD, Principal Investigator, Affiliation: Northwestern University
Summary
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.
Clinical Details
Official title: The Effect of Intraoperative Esmolol to Improve Postoperative Quality of Recovery and Pain After Ambulatory Surgery
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Qor-40 at 24 hours postoperative
Secondary outcome: Postoperative opioid consumptionPost operative pain reported by the subject. Postoperative pain sensitivity and threshold
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Prentice Womens Hospital, Chicago, Illinois 60611, United States
Additional Information
Starting date: January 2013
Last updated: April 29, 2015
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