Skip to main content
OpenTrials
Completed

NCT Number: NCT01048658

Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Blood Loss Anesthesia Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Lovejoy Surgicenter, Portland, Oregon, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevoflurane

Drug

Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.

Other names: Ultane

No Sevoflurane

Other

Subject only standard of care drug regimens for anesthesia with this procedure.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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).

  2. 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.

  3. Number of Participants Experiencing Side Effects (Nausea, Dizziness)

    Time frame: Post-procedure, within 30 minutes

  4. 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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

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?

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jan 13, 2010
Registry last updated
Aug 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.