Trial Outcomes & Findings for Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures (NCT NCT01048658)

NCT ID: NCT01048658

Last Updated: 2017-08-09

Results Overview

Provider report for need to intervene due to blood loss (yes/no)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 160 participants
• Primary outcome timeframe: At time of uterine evacuation and immediately post-operatively, an average of 7.1 minutes
• Results posted on: 2017-08-09

Participant Flow

Participant milestones

Measure	Sevoflurane Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure. Sevoflurane: 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. No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure.
Overall Study STARTED	80	80
Overall Study COMPLETED	80	80
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures

Baseline characteristics by cohort

Measure	Sevoflurane n=80 Participants Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure. Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.	No Sevoflurane n=80 Participants Subject receives standard of care drug regimens for anesthesia with this procedure. No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure.	Total n=160 Participants Total of all reporting groups
Age, Continuous	25.9 years STANDARD_DEVIATION 6.2 • n=5 Participants	25.9 years STANDARD_DEVIATION 5.9 • n=7 Participants	25.9 years STANDARD_DEVIATION 6.0 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	80 Participants n=7 Participants	160 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	80 participants n=5 Participants	80 participants n=7 Participants	160 participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Sevoflurane n=80 Participants Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure. Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.	No Sevoflurane n=80 Participants Subject receives standard of care drug regimens for anesthesia with this procedure. No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure.
Number of Participants Needing Intervention to Treat Blood Loss (a Composite of Use of Uterotonics, Re-aspiration, and Bimanual Massage)	20 Participants	13 Participants

SECONDARY outcome

Timeframe: At time of uterine evacuation, an average of 7.1 minutes

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).

Outcome measures

Measure	Sevoflurane n=80 Participants Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure. Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.	No Sevoflurane n=80 Participants Subject receives standard of care drug regimens for anesthesia with this procedure. No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure.
Number of Participants With Estimated Blood Loss Greater Than 300 mL (Yes/no)	12 Participants	6 Participants

SECONDARY outcome

Timeframe: Time of speculum place to time of speculum removal, an average of 7.1 minutes

Length of procedure from time of speculum placement to time of speculum removal, in minutes.

Outcome measures

Measure	Sevoflurane n=80 Participants Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure. Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.	No Sevoflurane n=80 Participants Subject receives standard of care drug regimens for anesthesia with this procedure. No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure.
Procedure Time: T-test (Time of Speculum Placement to Time Speculum Removed)	7.0 minutes Standard Deviation 3.7	7.3 minutes Standard Deviation 3.3

SECONDARY outcome

Timeframe: Post-procedure, within 30 minutes

Outcome measures

Measure	Sevoflurane n=80 Participants Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure. Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.	No Sevoflurane n=80 Participants Subject receives standard of care drug regimens for anesthesia with this procedure. No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure.
Number of Participants Experiencing Side Effects (Nausea, Dizziness)	13 Participants	11 Participants

SECONDARY outcome

Timeframe: Post-procedure, within 30 minutes

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.

Outcome measures

Measure	Sevoflurane n=80 Participants Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure. Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.	No Sevoflurane n=80 Participants Subject receives standard of care drug regimens for anesthesia with this procedure. No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure.
Patient and Provider Satisfaction With Anesthesia Provider Satisfaction	9.4 cm Standard Deviation 1.1	9.3 cm Standard Deviation 1.4
Patient and Provider Satisfaction With Anesthesia Patient Satisfaction	8.4 cm Standard Deviation 1.5	8.2 cm Standard Deviation 1.5

Adverse Events

Sevoflurane

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

No Sevoflurane

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sevoflurane n=80 participants at risk Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure. Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.	No Sevoflurane n=80 participants at risk Subject receives standard of care drug regimens for anesthesia with this procedure. No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure.
Reproductive system and breast disorders Blood loss and unterine atony	1.2% 1/80 • Number of events 1 • During and post-procedure	0.00% 0/80 • During and post-procedure

Other adverse events

Measure	Sevoflurane n=80 participants at risk Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure. Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.	No Sevoflurane n=80 participants at risk Subject receives standard of care drug regimens for anesthesia with this procedure. No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure.
Reproductive system and breast disorders Cervical laceration	2.5% 2/80 • Number of events 2 • During and post-procedure	1.2% 1/80 • Number of events 1 • During and post-procedure
Reproductive system and breast disorders Unterine atony	1.2% 1/80 • Number of events 1 • During and post-procedure	0.00% 0/80 • During and post-procedure

Additional Information

Dr. Rosenne Botha

Oregon Health & Science University

Phone: 503-494-3666

Email: whru@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place