CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 90 enrolled
Drug / intervention
Sevoflurane +1 moredrug
Likely dose
Propofol 2.0 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01755234
NCT01755234Phase 4Completed

The Effects of Propofol vs. Sevoflurane Administered During Anesthesia Maintenance on Early and Late Recovery After Gynecological Surgery

Northwestern University·interventional·Posted Dec 24, 2012·Updated Mar 14, 2016

In Brief

A Phase 4 clinical trial evaluating Sevoflurane and Propofol for Surgery and Anesthesia. Completed, enrolled 90 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSurgery, Anesthesia
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 24, 2012
Enrollment StartNov 1, 2012
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.5 years ago

Interventions

Sevofluranedrug

Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube

Propofoldrug

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