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Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures

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ClinicalTrials.gov Identifier: NCT01048658
Recruitment Status : Completed
First Posted : January 13, 2010
Results First Posted : August 9, 2017
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
Rosanne Botha, Oregon Health and Science University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Blood Loss Anesthesia Drug: Sevoflurane Other: No Sevoflurane Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
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 Start Date : September 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Sevoflurane

Arms and Interventions
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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 Name: 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048658


Locations
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United States, Oregon
Lovejoy Surgicenter
Portland, Oregon, United States, 97210
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Rosanne Botha, MD Oregon Health and Science University
More Information
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Publications:
Socio-Economic Factbook, S.A. Department, Editor. 1993, American College of Surgeons: Chicago, IL.
Paul, M., A Clinician's Guide to Medical and Surgical Abortion. 1999, New York, New York: Church Livingstone.

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Responsible Party: Rosanne Botha, Master of Public Health Student, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01048658    
Other Study ID Numbers: IRB - 5146
First Posted: January 13, 2010    Key Record Dates
Results First Posted: August 9, 2017
Last Update Posted: August 9, 2017
Last Verified: August 2017
Keywords provided by Rosanne Botha, Oregon Health and Science University:
Sevoflurane
anesthesia
abortion
blood loss
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
 Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs