Phase 4
N=90
Propofol Versus Sevoflurane Recovery After Gynecological Surgery
Surgery · Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT01755234 ↗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
| Outcome | Result | p-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
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.