Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures
Parole chiave
Astratto
Descrizione
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.
Date
| Ultimo verificato: | 07/31/2017 |
| Primo inviato: | 01/11/2010 |
| Iscrizione stimata inviata: | 01/11/2010 |
| Primo pubblicato: | 01/12/2010 |
| Ultimo aggiornamento inviato: | 08/06/2017 |
| Ultimo aggiornamento pubblicato: | 08/08/2017 |
| Data dei primi risultati presentati: | 06/13/2017 |
| Data dei primi risultati QC presentati: | 08/06/2017 |
| Data dei primi risultati pubblicati: | 08/08/2017 |
| Data di inizio effettiva dello studio: | 08/31/2009 |
| Data di completamento primaria stimata: | 11/30/2010 |
| Data stimata di completamento dello studio: | 07/31/2011 |
Condizione o malattia
Intervento / trattamento
Drug: Sevoflurane
Other: No Sevoflurane
Fase
Gruppi di braccia
| Braccio | Intervento / trattamento |
|---|---|
| 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. |
| 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. |
Criteri di idoneità
| Età idonea per lo studio | 18 Years Per 18 Years |
| Sessi idonei allo studio | Female |
| Accetta volontari sani | sì |
| Criteri | 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 |
Risultato
Misure di esito primarie
1. Number of Participants Needing Intervention to Treat Blood Loss (a Composite of Use of Uterotonics, Re-aspiration, and Bimanual Massage) [At time of uterine evacuation and immediately post-operatively, an average of 7.1 minutes]
Misure di esito secondarie
1. Number of Participants With Estimated Blood Loss Greater Than 300 mL (Yes/no) [At time of uterine evacuation, an average of 7.1 minutes]
2. Procedure Time: T-test (Time of Speculum Placement to Time Speculum Removed) [Time of speculum place to time of speculum removal, an average of 7.1 minutes]
3. Number of Participants Experiencing Side Effects (Nausea, Dizziness) [Post-procedure, within 30 minutes]
4. Patient and Provider Satisfaction With Anesthesia [Post-procedure, within 30 minutes]
