Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures

Anesthesia Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01048658
• Other study ID #: IRB - 5146
• Status: Completed
• Phase: Phase 4
• First received: January 12, 2010
• Last updated: August 7, 2017
• Start date: September 2009
• Est. completion date: August 2011

Study information

• Verified date: August 2017
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Blood Loss
• Hemorrhage

Intervention

Drug:
• Sevoflurane
Subject receives Sevoflurane in addition to other 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.

Locations

Country	Name	City	State
United States	Lovejoy Surgicenter	Portland	Oregon
United States	Oregon Health and Sciences University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (21)

Abboud TK, D'Onofrio L, Reyes A, Mosaad P, Zhu J, Mantilla M, Gangolly J, Crowell D, Cheung M, Afrasiabi A, et al. Isoflurane or halothane for cesarean section: comparative maternal and neonatal effects. Acta Anaesthesiol Scand. 1989 Oct;33(7):578-81. — View Citation

Collins, K.M., et al., Outpatient termination of pregnancy: halothane or alfentanil-supplemented anaesthesia. Br J Anaesth, 1985. 57(12): p. 1226-31. 10. Galbert, M.W. and A.E. Gardner, Use of halothane in a balanced technic for cesarean section. Anesth Analg, 1972. 51(5): p. 701-4.

Cullen BF, Margolis AJ, Eger EI 2nd. The effects of anesthesia and pulmonary ventilation on blood loss during elective therapeutic abortion. Anesthesiology. 1970 Feb;32(2):108-13. — View Citation

Forrest WH Jr. Effects of anesthesia in therapeutic abortion. Anesthesiology. 1970 Jul;33(1):121-2. — View Citation

Gambling DR, Sharma SK, White PF, Van Beveren T, Bala AS, Gouldson R. Use of sevoflurane during elective cesarean birth: a comparison with isoflurane and spinal anesthesia. Anesth Analg. 1995 Jul;81(1):90-5. — View Citation

Jackson RA, Teplin VL, Drey EA, Thomas LJ, Darney PD. Digoxin to facilitate late second-trimester abortion: a randomized, masked, placebo-controlled trial. Obstet Gynecol. 2001 Mar;97(3):471-6. — View Citation

Karaman S, Akercan F, Aldemir O, Terek MC, Yalaz M, Firat V. The maternal and neonatal effects of the volatile anaesthetic agents desflurane and sevoflurane in caesarean section: a prospective, randomized clinical study. J Int Med Res. 2006 Mar-Apr;34(2):183-92. — View 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. — View Citation

Method, weeks of gestation key in abortion complications. Contracept Technol Update. 1980 Oct;1(7):96-7. — View Citation

Nathan N, Peyclit A, Lahrimi A, Feiss P. Comparison of sevoflurane and propofol for ambulatory anaesthesia in gynaecological surgery. Can J Anaesth. 1998 Dec;45(12):1148-50. — View Citation

Nelskylä K, Korttila K, Yli-Hankala A. Comparison of sevoflurane-nitrous oxide and propofol-alfentanil-nitrous oxide anaesthesia for minor gynaecological surgery. Br J Anaesth. 1999 Oct;83(4):576-9. — View 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. — View Citation

Patel SS, Goa KL. Sevoflurane. A review of its pharmacodynamic and pharmacokinetic properties and its clinical use in general anaesthesia. Drugs. 1996 Apr;51(4):658-700. Review. Erratum in: Drugs 1996 Aug;52(2):253. — View Citation

Paul, M., A Clinician's Guide to Medical and Surgical Abortion. 1999, New York, New York: Church Livingstone.

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. — View Citation

Socio-Economic Factbook, S.A. Department, Editor. 1993, American College of Surgeons: Chicago, IL.

Turner RJ, Lambrost M, Holmes C, Katz SG, Downs CS, Collins DW, Gatt SP. The effects of sevoflurane on isolated gravid human myometrium. Anaesth Intensive Care. 2002 Oct;30(5):591-6. — View Citation

Turok DK, Gurtcheff SE, Esplin MS, Shah M, Simonsen SE, Trauscht-Van Horn J, Silver RM. Second trimester termination of pregnancy: a review by site and procedure type. Contraception. 2008 Mar;77(3):155-61. doi: 10.1016/j.contraception.2007.11.004. Epub 2008 Jan 11. — View Citation

West SL, Moore CA, Gillard M, Browne PD. Anaesthesia for suction termination of pregnancy. Anaesthesia. 1985 Jul;40(7):669-72. — View Citation

Yamakage M, Tsujiguchi N, Chen X, Kamada Y, Namiki A. Sevoflurane inhibits contraction of uterine smooth muscle from pregnant rats similarly to halothane and isoflurane. Can J Anaesth. 2002 Jan;49(1):62-6. — View Citation

Yeo ST, Holdcroft A, Yentis SM, Stewart A, Bassett P. Analgesia with sevoflurane during labour: ii. Sevoflurane compared with Entonox for labour analgesia. Br J Anaesth. 2007 Jan;98(1):110-5. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Number of Participants Experiencing Side Effects (Nausea, Dizziness)		Post-procedure, within 30 minutes
Secondary	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