Clinical Trials Directory

Trials / Completed

CompletedNCT01048658

Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures

Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures: Does it Increase Blood Loss and Interventions for Blood Loss and Why Do Anesthesiologists Choose to Use It?

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
160 (actual)
Sponsor
Oregon Health and Science University · Academic / Other
Sex
Female
Age
18 Years – 50 Years
Healthy volunteers
Accepted

Summary

Sevoflurane is an FDA-approved anesthetic drug commonly used for anesthesia during second trimester abortion procedures. It has a few advantages, including ease of use by the anesthesia provider. However, the literature suggests that when used in doses higher than those used at Oregon Health \& Science University (OHSU) and Lovejoy, it is associated with an increase in the risk of bleeding. The investigators study aims to test whether the lower dose used at OHSU and Lovejoy during second trimester abortion procedures causes any difference in blood loss, when compared to similar abortion procedures for which this drug is not used.

Detailed description

This study seeks to examine the bleeding complications associated with use of sevoflurane in general anesthesia regimens for second trimester abortion procedures and assess anesthesia providers' use and beliefs regarding possible risks associated with newer inhalational agents such as sevoflurane in this setting. Participants' anesthesia will either be intravenous (IV) propofol, IV midazolam, IV fentanyl and nitrous oxide or this same regimen combined with sevoflurane during maintenance of anesthesia. Procedural outcomes, specifically those related to bleeding complications, including need to intervene for excess blood loss, will be recorded and analyzed to establish if such a relationship between use of sevoflurane and excess blood loss exists.

Conditions

Interventions

TypeNameDescription
DRUGSevofluraneSubject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.
OTHERNo SevofluraneSubject only standard of care drug regimens for anesthesia with this procedure.

Timeline

Start date
2009-09-01
Primary completion
2010-12-01
Completion
2011-08-01
First posted
2010-01-13
Last updated
2017-08-09
Results posted
2017-08-09

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01048658. Inclusion in this directory is not an endorsement.