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Phase 4 N=90 Randomized Triple-blind Treatment

Propofol Versus Sevoflurane Recovery After Gynecological Surgery

Surgery · Anesthesia

Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Quality of Recovery Score 24 Hours Post Operative — 175; 176 units on a scale — p=0.97

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Sevoflurane (Drug); Propofol (Drug)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
Northwestern University
Primary completion
Apr 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Quality of Recovery Score 24 Hours Post Operative
175; 176 0.97
SECONDARY
Mg of Morphine Equivalents (IV)
9; 9.4 0.96
SECONDARY
Pain in Post Anesthesia Care Unit
270; 240 .96
SECONDARY
Opioid Use Discharge From Post Anesthesia Care Unit to 24 Hours After PACU Discharge.
30; 25 .84

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01755234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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