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Propofol Versus Sevoflurane Recovery After Gynecological Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier:
NCT01755234
First received: December 18, 2012
Last updated: February 18, 2016
Last verified: February 2016
  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 after the surgical procedure ] [ Designated as safety issue: No ]
    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:
  • Mg of Morphine Equivalents (IV) [ Time Frame: PACU admission to discharge ] [ Designated as safety issue: No ]
    Total opioid use in the post operative care unit (Mg of morphine equivalents)

  • Pain in Post Anesthesia Care Unit [ Time Frame: Time in the post anesthesia care unit ] [ Designated as safety issue: No ]

    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.


  • 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. ] [ Designated as safety issue: No ]
    Opioid use in mg of morphine equivalents from discharge from the post anesthesia care unit to 24 hours after PACU discharge.


Enrollment: 90
Study Start Date: November 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
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

Locations
United States, Illinois
Prentice Women's Hospital
Chicago, Illinois, United States, 60611
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
Results First Received: June 19, 2015
Last Updated: February 18, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Northwestern University:
Outpatient
Surgery
Anesthesia

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

ClinicalTrials.gov processed this record on September 26, 2016