Blood LossPhase 4NCT01048658
Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures
A Phase 4 study testing Sevoflurane and No Sevoflurane in people with Blood Loss and Anesthesia, run by Oregon Health and Science University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Loss, Anesthesia
- What is being tested?
- Sevoflurane and No Sevoflurane
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to Aug 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lovejoy Surgicenter
Portland, Oregon, 97210
Oregon Health and Sciences University
Portland, Oregon, 97239
About this study
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?
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.
Read the detailed 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.
- Conditions
- Blood Loss, Anesthesia
- Being tested
- Sevoflurane, No Sevoflurane
- Keywords
- Sevoflurane, anesthesia, abortion, blood loss
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called Ultane
Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.
No SevofluraneOther
Subject only standard of care drug regimens for anesthesia with this procedure.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Active comparator | Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure. Receives: Drug: Sevoflurane |
| No Sevoflurane | Placebo comparator | Subject receives standard of care drug regimens for anesthesia with this procedure. Receives: Other: No Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
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).
Measured: At time of uterine evacuation, an average of 7.1 minutes
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.
Measured: Time of speculum place to time of speculum removal, an average of 7.1 minutes
Number of Participants Experiencing Side Effects (Nausea, Dizziness)
Measured: Post-procedure, within 30 minutes
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.
Measured: Post-procedure, within 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startSep 2009
- Primary completionDec 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Blood LossStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosanne Botha, Oregon Health and Science University
- Investigators
- Rosanne Botha, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048658
- Sponsor's protocol ID
- IRB - 5146
- Status last verified
- Aug 2017
- First submitted
- 12 Jan 2010
- Last updated
- 9 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Socio-Economic Factbook, S.A. Department, Editor. 1993, American College of Surgeons: Chicago, IL.
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.
PubMed 6866362Method, weeks of gestation key in abortion complications. Contracept Technol Update. 1980 Oct;1(7):96-7.
PubMed 12336808MacKay 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.
PubMed 4058825O'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.
PubMed 19014796Abboud 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.
PubMed 2816239West 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.
PubMed 4025771Collins 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.
PubMed 3936528Forrest WH Jr. Effects of anesthesia in therapeutic abortion. Anesthesiology. 1970 Jul;33(1):121-2. doi: 10.1097/00000542-197007000-00028. No abstract available.
PubMed 4393415Cullen 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.
PubMed 4391841Patel 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.
PubMed 8706599Yamakage 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.
PubMed 11782330Turner 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.
PubMed 12413258Nathan 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.
PubMed 10051930
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT01048658
- Acronym / sponsor ID
- IRB - 5146
- Conditions
- Blood Loss, Anesthesia
- Keywords
- Sevoflurane, anesthesia, abortion, blood loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Posted 9 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Active comparator | Drug: SevofluraneSubject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure. |
| No Sevoflurane | Placebo comparator | Other: No SevofluraneSubject receives standard of care drug regimens for anesthesia with this procedure. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneAlso: UltaneSubject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure. | Drug | Sevoflurane |
| No SevofluraneSubject only standard of care drug regimens for anesthesia with this procedure. | Other | No Sevoflurane |
Primary outcome
Number of Participants Needing Intervention to Treat Blood Loss (a Composite of Use of Uterotonics, Re-aspiration, and Bimanual Massage)
Time frame: At time of uterine evacuation and immediately post-operatively, an average of 7.1 minutes
Provider report for need to intervene due to blood loss (yes/no)
4 secondary outcomes
Number of Participants With Estimated Blood Loss Greater Than 300 mL (Yes/no)
Time frame: At time of uterine evacuation, an average of 7.1 minutes
Procedure Time: T-test (Time of Speculum Placement to Time Speculum Removed)
Time frame: Time of speculum place to time of speculum removal, an average of 7.1 minutes
Number of Participants Experiencing Side Effects (Nausea, Dizziness)
Time frame: Post-procedure, within 30 minutes
Patient and Provider Satisfaction With Anesthesia
Time frame: Post-procedure, within 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundSocio-Economic Factbook, S.A. Department, Editor. 1993, American College of Surgeons: Chicago, IL.
- BackgroundPaul, M., A Clinician's Guide to Medical and Surgical Abortion. 1999, New York, New York: Church Livingstone.
- Background: PubMed 6866362Peterson 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.
- Background: PubMed 12336808Method, weeks of gestation key in abortion complications. Contracept Technol Update. 1980 Oct;1(7):96-7.
- Background: PubMed 4058825MacKay 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.
- Background: PubMed 19014796O'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.
- Background: PubMed 2816239Abboud 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.
- Background: PubMed 4025771West 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.
- Background: PubMed 3936528Collins 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.
- Background: PubMed 4393415Forrest WH Jr. Effects of anesthesia in therapeutic abortion. Anesthesiology. 1970 Jul;33(1):121-2. doi: 10.1097/00000542-197007000-00028. No abstract available.
- Background: PubMed 4391841Cullen 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.
- Background: PubMed 8706599Patel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosanne Botha, MD principal investigator
Oregon Health and Science University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevoflurane and No Sevoflurane in people with Blood Loss and Anesthesia, run by Oregon Health and Science University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Needing Intervention to Treat Blood Loss (a Composite of Use of Uterotonics, Re-aspiration, and Bimanual Massage) (time frame: At time of uterine evacuation and immediately post-operatively, an average of 7.1 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01048658, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017; AzTrials last refreshed its copy on 6 Nov 2026.