Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures

Study Overview
=================
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.

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?

Conditions
-----------------
Blood Loss, Anesthesia

Intervention / Treatment
-----------------
* Drug: Sevoflurane
* Other: No Sevoflurane


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sevoflurane<br>Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure. | Drug: Sevoflurane<br>* Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.<br>* Other names: Ultane;|
| Placebo Comparator: No Sevoflurane<br>Subject receives standard of care drug regimens for anesthesia with this procedure. | Other: No Sevoflurane<br>* Subject only standard of care drug regimens for anesthesia with this procedure.<br>|

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) | 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) | 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) | 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) |  | Post-procedure, within 30 minutes | 
| 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. | Post-procedure, within 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sevoflurane, anesthesia, abortion, blood loss