CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 70 enrolled
Drug / intervention
Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min +1 moredrug
Likely dose
Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/minfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01782898
NCT01782898N/ACompleted

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

Northwestern University·interventional·Posted Feb 4, 2013·Updated Nov 11, 2016

In Brief

A clinical study evaluating Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min and Placebo Comparator: .9 normal saline for Pain. Completed, enrolled 70 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 4, 2013
Enrollment StartJan 1, 2013
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 13.4 years ago

Interventions

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

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

Placebo Comparator: .9 normal salinedrug

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,