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Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures

Primary Purpose

Blood Loss, Anesthesia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sevoflurane
No Sevoflurane
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Blood Loss focused on measuring Sevoflurane, anesthesia, abortion, blood loss

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Lovejoy Surgicenter
  • Oregon Health and Sciences University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sevoflurane

No Sevoflurane

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Participants Needing Intervention to Treat Blood Loss (a Composite of Use of Uterotonics, Re-aspiration, and Bimanual Massage)
Provider report for need to intervene due to blood loss (yes/no)

Secondary Outcome Measures

Number of Participants With Estimated Blood Loss Greater Than 300 mL (Yes/no)
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).
Procedure Time: T-test (Time of Speculum Placement to Time Speculum Removed)
Length of procedure from time of speculum placement to time of speculum removal, in minutes.
Number of Participants Experiencing Side Effects (Nausea, Dizziness)
Patient and Provider Satisfaction With Anesthesia
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.

Full Information

First Posted
January 12, 2010
Last Updated
August 7, 2017
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT01048658
Brief Title
Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures
Official 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?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Anesthesia
Keywords
Sevoflurane, anesthesia, abortion, blood loss

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sevoflurane
Arm Type
Active Comparator
Arm Description
Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.
Arm Title
No Sevoflurane
Arm Type
Placebo Comparator
Arm Description
Subject receives standard of care drug regimens for anesthesia with this procedure.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Ultane
Intervention Description
Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.
Intervention Type
Other
Intervention Name(s)
No Sevoflurane
Intervention Description
Subject only standard of care drug regimens for anesthesia with this procedure.
Primary Outcome Measure Information:
Title
Number of Participants Needing Intervention to Treat Blood Loss (a Composite of Use of Uterotonics, Re-aspiration, and Bimanual Massage)
Description
Provider report for need to intervene due to blood loss (yes/no)
Time Frame
At time of uterine evacuation and immediately post-operatively, an average of 7.1 minutes
Secondary Outcome Measure Information:
Title
Number of Participants With Estimated Blood Loss Greater Than 300 mL (Yes/no)
Description
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).
Time Frame
At time of uterine evacuation, an average of 7.1 minutes
Title
Procedure Time: T-test (Time of Speculum Placement to Time Speculum Removed)
Description
Length of procedure from time of speculum placement to time of speculum removal, in minutes.
Time Frame
Time of speculum place to time of speculum removal, an average of 7.1 minutes
Title
Number of Participants Experiencing Side Effects (Nausea, Dizziness)
Time Frame
Post-procedure, within 30 minutes
Title
Patient and Provider Satisfaction With Anesthesia
Description
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.
Time Frame
Post-procedure, within 30 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosanne Botha, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lovejoy Surgicenter
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Oregon Health and Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Socio-Economic Factbook, S.A. Department, Editor. 1993, American College of Surgeons: Chicago, IL.
Results Reference
background
Citation
Paul, M., A Clinician's Guide to Medical and Surgical Abortion. 1999, New York, New York: Church Livingstone.
Results Reference
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PubMed Identifier
6866362
Citation
Peterson WF, Berry FN, Grace MR, Gulbranson CL. Second-trimester abortion by dilatation and evacuation: an analysis of 11,747 cases. Obstet Gynecol. 1983 Aug;62(2):185-90.
Results Reference
background
PubMed Identifier
12336808
Citation
Method, weeks of gestation key in abortion complications. Contracept Technol Update. 1980 Oct;1(7):96-7.
Results Reference
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PubMed Identifier
4058825
Citation
MacKay HT, Schulz KF, Grimes DA. Safety of local versus general anesthesia for second-trimester dilatation and evacuation abortion. Obstet Gynecol. 1985 Nov;66(5):661-5.
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PubMed Identifier
19014796
Citation
O'Connell K, Jones HE, Lichtenberg ES, Paul M. Second-trimester surgical abortion practices: a survey of National Abortion Federation members. Contraception. 2008 Dec;78(6):492-9. doi: 10.1016/j.contraception.2008.07.011. Epub 2008 Sep 4.
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2816239
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Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures

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