Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures

NCT01048658 | Completed Phase 4 Results DMC

• 1 other identifier: IRB - 5146
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Blood Loss; Anesthesia

Keywords

Sevoflurane; anesthesia; abortion; blood loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants With Estimated Blood Loss Greater Than 300 mL (Yes/no)

  At time of uterine evacuation, an average of 7.1 minutes

• 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

• Number of Participants Experiencing Side Effects (Nausea, Dizziness)

  Post-procedure, within 30 minutes

• Patient and Provider Satisfaction With Anesthesia

  Post-procedure, within 30 minutes

Study Arms (2)

Sevoflurane

ACTIVE COMPARATOR

Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.

Drug: Sevoflurane

No Sevoflurane

PLACEBO COMPARATOR

Subject receives standard of care drug regimens for anesthesia with this procedure.

Other: No Sevoflurane

Interventions

Sevoflurane DRUG

Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.

Also known as: Ultane

Sevoflurane

No Sevoflurane OTHER

Subject only standard of care drug regimens for anesthesia with this procedure.

No Sevoflurane

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (2)

Lovejoy Surgicenter

Portland, Oregon, 97210, United States

Location

Oregon Health and Sciences University

Portland, Oregon, 97239, United States

Location

Related Publications (21)

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 6866362 BACKGROUND

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

  PMID: 12336808 BACKGROUND

• 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.

  PMID: 4058825 BACKGROUND

• 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.

  PMID: 19014796 BACKGROUND

• 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. doi: 10.1111/j.1399-6576.1989.tb02970.x.

  PMID: 2816239 BACKGROUND

• West SL, Moore CA, Gillard M, Browne PD. Anaesthesia for suction termination of pregnancy. Anaesthesia. 1985 Jul;40(7):669-72. doi: 10.1111/j.1365-2044.1985.tb10948.x.

  PMID: 4025771 BACKGROUND

• Collins KM, Plantevin OM, Whitburn RH, Doyle JP. Outpatient termination of pregnancy: halothane or alfentanil-supplemented anaesthesia. Br J Anaesth. 1985 Dec;57(12):1226-31. doi: 10.1093/bja/57.12.1226.

  PMID: 3936528 BACKGROUND

• Forrest WH Jr. Effects of anesthesia in therapeutic abortion. Anesthesiology. 1970 Jul;33(1):121-2. doi: 10.1097/00000542-197007000-00028. No abstract available.

  PMID: 4393415 BACKGROUND

• 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. doi: 10.1097/00000542-197002000-00004. No abstract available.

  PMID: 4391841 BACKGROUND

• 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. doi: 10.2165/00003495-199651040-00009.

  PMID: 8706599 BACKGROUND

• 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. doi: 10.1007/BF03020420.

  PMID: 11782330 BACKGROUND

• 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. doi: 10.1177/0310057X0203000508.

  PMID: 12413258 BACKGROUND

• 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. doi: 10.1007/BF03012454.

  PMID: 10051930 BACKGROUND

• Nelskyla 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. doi: 10.1093/bja/83.4.576.

  PMID: 10673872 BACKGROUND

• 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. doi: 10.1177/147323000603400208.

  PMID: 16749414 BACKGROUND

• 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. doi: 10.1097/00000539-199507000-00018.

  PMID: 7598289 BACKGROUND

• Toscano A, Pancaro C, Giovannoni S, Minelli G, Baldi C, Guerrieri G, Crowhurst JA, Peduto VA. Sevoflurane analgesia in obstetrics: a pilot study. Int J Obstet Anesth. 2003 Apr;12(2):79-82. doi: 10.1016/S0959-289X(02)00195-4.

  PMID: 15321492 BACKGROUND

• 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. doi: 10.1016/s0029-7844(00)01148-0.

  PMID: 11239659 BACKGROUND

• 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.

  PMID: 18279684 BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Results Point of Contact

• Title: Dr. Rosenne Botha
• Organization: Oregon Health & Science University

whru@ohsu.edu

503-494-3666

Study Officials

• Rosanne Botha, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Public Health Student, MD

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 13, 2010
• Study Start: September 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: August 1, 2011
• Last Updated: August 9, 2017
• Results First Posted: August 9, 2017

Record last verified: 2017-08

Locations

US (2)