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

NCT01782898 | Completed Results

• 1 other identifier: STU00066623
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Keywords

Anesthesia; MEDOC neuro sensory analyzer; Pain; Quality of recovery

Outcome Measures

Primary Outcomes (1)

• Qor-40 at 24 Hours Postoperative

  Quality of recovery questionnaire score at 24 hours after surgery. Quality of recovery score 24 hours after the surgical procedure.Score of 40 is poor recovery and a score of 200 is good recovery. Time frame for this evaluation is 24 hours after the surgical procedure

  24 hours

Secondary Outcomes (2)

• Postoperative Opioid Consumption

  24 hours

• Post Operative Pain Reported by the Subject.

  24 hour

Study Arms (2)

Esmolol

ACTIVE COMPARATOR

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

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

.9 normal saline

PLACEBO COMPARATOR

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

Drug: Placebo Comparator: .9 normal saline

Interventions

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

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

Also known as: Esmolol

Esmolol

Placebo Comparator: .9 normal saline DRUG

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,

Also known as: Normal Saline

.9 normal saline

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Prentice Womens Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Pain

Interventions

esmolol; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Gildasio De Oliveira, M.D.
• Organization: Northwestern University

gjr@northwestern.edu

312-695-4858

Study Officials

• Gildasio De Oliveira, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinipal Investigator

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 4, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 11, 2016
• Results First Posted: April 4, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)