Propofol Versus Sevoflurane Recovery After Gynecological Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier:
NCT01755234
First received: December 18, 2012
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Surgery
Anesthesia
Drug: Sevoflurane
Drug: Propofol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Propofol vs. Sevoflurane Administered During Anesthesia Maintenance on Early and Late Recovery After Gynecological Surgery

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Quality of recovery score 24 hours post operative [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Quality of recovery score 24 hours post operative


Estimated Enrollment: 80
Study Start Date: December 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sevoflurane
Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)
Drug: Sevoflurane
Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube
Other Name: Sevoflurane,Ultane
Active Comparator: 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
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
Other Name: Propofol,Diprivan

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women
  • Age 18-64
  • Patients undergoing ambulatory surgery
  • ASA PS I, II

Exclusion Criteria:

  • Chronic opioid use
  • Pregnant patient

Drop Out : patient or surgeon request

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755234

Contacts
Contact: Gildasio De Oliveira, MD (312)472-3585 gjr@northwestern.edu

Locations
United States, Illinois
Prentice Womens Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Gildasio De Oliveira, MD         
Principal Investigator: Gildasio De Oliveira, MD         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Gildasio De Oliveira, MD Northwestern University
  More Information

Publications:

Responsible Party: Gildasio De Oliveira, Prinipal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01755234     History of Changes
Other Study ID Numbers: STU00070833
Study First Received: December 18, 2012
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
Outpatient
Surgery
Anesthesia

Additional relevant MeSH terms:
Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on September 18, 2014