Phase 4
Completed N=160
Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures
Blood Loss · Anesthesia
Source: ClinicalTrials.gov NCT01048658 ↗
Enrolled (actual)
160
Serious AEs
0.6%
Results posted
Aug 2017
Primary outcomePrimary: Number of Participants Needing Intervention to Treat Blood Loss (a Composite of Use of Uterotonics, Re-aspiration, and Bimanual Massage) — 20; 13 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Needing Intervention to Treat Blood Loss (a Composite of Use of Uterotonics, Re-aspiration, and Bimanual Massage) |
20; 13 | — |
| SECONDARY Number of Participants With Estimated Blood Loss Greater Than 300 mL (Yes/no) |
12; 6 | — |
| SECONDARY Procedure Time: T-test (Time of Speculum Placement to Time Speculum Removed) |
7.0; 7.3 | — |
| SECONDARY Number of Participants Experiencing Side Effects (Nausea, Dizziness) |
13; 11 | — |
| SECONDARY Patient and Provider Satisfaction With Anesthesia |
9.4; 9.3; 8.4; 8.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT01048658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.