Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures

August 7, 2017 updated by: Rosanne Botha, Oregon Health and Science University

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?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Sciences University
      • Portland, Oregon, United States, 97210
        • Lovejoy Surgicenter

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Voluntarily requesting pregnancy termination
  • Estimated gestational age of 18 weeks - 23 weeks, 6 days gestational age as calculated by fetal biparietal diameter on clinic ultrasound.
  • Be able and willing to sign an informed consent and agree to terms of the study

Exclusion Criteria:

  • Known severe maternal respiratory disease or upper respiratory infection or sinus blockage
  • Anticoagulation use: within 24 hours if Lovenox, or within 12 hours if heparin, (Must have a documented normal international normalized ratio (INR) prior to procedure if on anticoagulation)
  • Multiple pregnancy
  • Fetal demise, if more than 2 weeks difference exists between known gestational age (by previous US dating) and gestational size on current ultrasound.
  • Known allergy/sensitivity to sevoflurane or any other inhaled anesthetic agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Sevoflurane
Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.
Drug: Sevoflurane
Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.
Other Names:
  • Ultane
PLACEBO_COMPARATOR: No Sevoflurane
Subject receives standard of care drug regimens for anesthesia with this procedure.
Other: No Sevoflurane
Subject only standard of care drug regimens for anesthesia with this procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Needing Intervention to Treat Blood Loss (a Composite of Use of Uterotonics, Re-aspiration, and Bimanual Massage)
Time Frame: At time of uterine evacuation and immediately post-operatively, an average of 7.1 minutes
Provider report for need to intervene due to blood loss (yes/no)
At time of uterine evacuation and immediately post-operatively, an average of 7.1 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Estimated Blood Loss Greater Than 300 mL (Yes/no)
Time Frame: At time of uterine evacuation, an average of 7.1 minutes
Procedural blood loss greater than 300 mL. Blood loss was measured in a standardized fashion (amniotic fluid was discarded, blood was separated from tissue, and all gauze surgical drapes weighed).
At time of uterine evacuation, an average of 7.1 minutes
Procedure Time: T-test (Time of Speculum Placement to Time Speculum Removed)
Time Frame: Time of speculum place to time of speculum removal, an average of 7.1 minutes
Length of procedure from time of speculum placement to time of speculum removal, in minutes.
Time of speculum place to time of speculum removal, an average of 7.1 minutes
Number of Participants Experiencing Side Effects (Nausea, Dizziness)
Time Frame: Post-procedure, within 30 minutes
Post-procedure, within 30 minutes
Patient and Provider Satisfaction With Anesthesia
Time Frame: Post-procedure, within 30 minutes
Scores reported on 10-cm Visual Analog Scale (VAS anchors: 0= not satisfied at all, 10= completely satisfied) . Reported as mean +/- standard deviation. Subjects and providers were blinded to anesthesia method. Subjects and providers completed post-operative questionnaire within 30 minutes of procedure completion.
Post-procedure, within 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Investigators

  • Principal Investigator: Rosanne Botha, MD, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

January 12, 2010

First Submitted That Met QC Criteria

January 12, 2010

First Posted (ESTIMATE)

January 13, 2010

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2017

Last Update Submitted That Met QC Criteria

August 7, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB - 5146

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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