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Propofol Versus Sevoflurane Recovery After Gynecological Surgery

NCT01755234 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2016-03-14

Study results available
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Summary

80% of 25 million American who undergo surgery describe moderate to severe pain. The use of multimodal analgesic techniques can attenuate patient's postoperative pain and several different medication have been found to be effective. Pain can significantly affect patient's quality of recovery after surgery. Volatile anesthetics can increase sensitivity to pain at the low concentrations present on emergence from anesthesia. Propofol may have analgesic effect at sedative doses. The effects of propofol,when used for anesthesia maintenance, on postoperative pain have demonstrated controversial results with some investigators showing a potential benefit whereas others have not shown any benefit. Propofol for maintenance of anesthesia has been advocated as an strategy for high risk patients even though it has shown controversial results on reduction of Post operative nausea and vomiting. A comparison of propofol vs.volatile anesthetic in regards to the time required by patients to meet discharge criteria has also shown conflicting results.The QOR 40 is a validated instrument that has been specifically developed to evaluate patients recovery after anesthesia and surgery.

The purpose of this study is to compare the effects of maintenance of anesthesia with two agents (Propofol and Sevoflurane) on quality of recovery after ambulatory surgery

Significance: the results of this study can lead to the discovery of an anesthesia technique that is associated with a better recovery for patients after ambulatory surgery.

Research question is: do patients anesthetized with propofol have a better quality of recovery after ambulatory anesthesia than patients anesthetized with Sevoflurane? The hypothesis: patients anesthetized with propofol will have better quality of recovery than patients anesthetized with Sevoflurane after ambulatory surgery.

Conditions

  • Surgery
  • Anesthesia

Interventions

DRUG

Sevoflurane

Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube

DRUG

Propofol

Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60

Sponsors & Collaborators

Principal Investigators

  • Gildasio De Oliveira, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01755234 on ClinicalTrials.gov