COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Propofol Versus Sevoflurane Recovery After Gynecological Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01755234
Recruitment Status : Completed
First Posted : December 24, 2012
Results First Posted : March 14, 2016
Last Update Posted : March 14, 2016
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University

Brief 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.

Condition or disease Intervention/treatment Phase
Surgery Anesthesia Drug: Sevoflurane Drug: Propofol Phase 4

Detailed Description:
Subjects will be recruited up to the day of surgery. 90 subjects will be randomly allocated into 2 groups, using a computer generated table of random numbers: anesthetic maintenance with Sevoflurane or anesthetic maintenance with Propofol . Subjects will be premedicated with intravenous (IV) midazolam 0.04 mg/kg. Routine ASA monitors will be applied. Anesthesia will be induced with remifentanil infusion started at 0.1 mcg/kg/minute titrated to keep blood pressure within 20% of the baseline and propofol 1.0 -2.0 mg/kg or sevoflurane induction. Tracheal intubation will be facilitated with rocuronium (0.6 mg/kg) or succinylcholine (1-2mg /kg). Anesthesia will be maintained with Sevoflurane or a Propofol infusion titrated to keep a bispectral index between 40-60, remifentanil infusion started at 0.1mcg/kg/min titrated to keep blood pressure within 20 % of baseline values, and rocuronium that will be administered at the discretion of the anesthesiologist. Upon termination of the surgery, neuromuscular blockade will be antagonized with a combination of neostigmine 0.05mg/kg and glycopyrrolate 0.01 mg/kg. Subjects will also receive Ketorolac 30 mg IV after discontinuation of remifentanil for postoperative pain control. Ondansetron 4 mg IV will be administered to decrease postoperative nausea and vomiting. Subjects will receive IV hydromorphone 0.4 mg q 5 minutes as needed to achieve a verbal rating score for pain <4 out of 10.They will also receive reglan 10 mg IV as a rescue antiemetic, if not effective, a second dose of Zofran 4 mg IV will be given in PACU. 24 hours after surgery a QOR 40 will be administered to the patient by one of the investigators. The primary and secondary outcomes will be assessed by an independent observer who will be blinded to group allocation.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Propofol vs. Sevoflurane Administered During Anesthesia Maintenance on Early and Late Recovery After Gynecological Surgery
Study Start Date : November 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Quality of Recovery Score 24 Hours Post Operative [ Time Frame: 24 hours after the surgical procedure ]
    Quality of recovery score 24 hours after the surgical procedure.Score of 40 is poor recovery and a score of 200 is good recovery.

Secondary Outcome Measures :
  1. Mg of Morphine Equivalents (IV) [ Time Frame: PACU admission to discharge ]
    Total opioid use in the post operative care unit (Mg of morphine equivalents)

  2. Pain in Post Anesthesia Care Unit [ Time Frame: Time in the post anesthesia care unit ]

    Numeric rating scale for pain on a scale of 0-10 (0 is no pain and 10 is high pain) versus time curve in the post anesthesia care unit ( score * min). A higher value indicates more pain and time in the Post Anesthesia Care Unit.

    The range is 0 pain to x time in minutes x 1 hour to 5 hour ( 60-300 minutes) . The pain scores were collected at 15 minute intervals from the time of admission to the PACU. The area under the NRS pain scale versus time curve was calculated using the trapezoidal method as an indicator of pain burden during early recovery (Graph Pad Prism ver 5.03, Graph Pad Software INC.

  3. Opioid Use Discharge From Post Anesthesia Care Unit to 24 Hours After PACU Discharge. [ Time Frame: Discharge from PACU to 24 hours post operative after PACU discharge. ]
    Opioid use in mg of morphine equivalents from discharge from the post anesthesia care unit to 24 hours after PACU discharge.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01755234

Layout table for location information
United States, Illinois
Prentice Women's Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Layout table for investigator information
Principal Investigator: Gildasio De Oliveira, MD Northwestern University

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Gildasio De Oliveira, Prinipal Investigator, Northwestern University Identifier: NCT01755234    
Other Study ID Numbers: STU00070833
First Posted: December 24, 2012    Key Record Dates
Results First Posted: March 14, 2016
Last Update Posted: March 14, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gildasio De Oliveira, Northwestern University:
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation