Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures

NCT ID: NCT01048658

Last Updated: 2017-08-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-08-31

Brief Summary

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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

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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.

Conditions

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Blood Loss Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sevoflurane

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

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

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

No Sevoflurane

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

Group Type PLACEBO_COMPARATOR

No Sevoflurane

Intervention Type OTHER

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

Interventions

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Sevoflurane

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

Intervention Type DRUG

No Sevoflurane

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

Intervention Type OTHER

Other Intervention Names

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Ultane

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Rosanne Botha

Master of Public Health Student, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rosanne Botha, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Lovejoy Surgicenter

Portland, Oregon, United States

Site Status

Oregon Health and Sciences University

Portland, Oregon, United States

Site Status

Countries

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United States

References

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

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 6866362 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 12336808 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4058825 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19014796 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2816239 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4025771 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3936528 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4393415 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4391841 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8706599 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11782330 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12413258 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10051930 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10673872 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16749414 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7598289 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15321492 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11239659 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18279684 (View on PubMed)

Other Identifiers

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IRB - 5146

Identifier Type: -

Identifier Source: org_study_id

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