Trial Outcomes & Findings for Japan Phase 2/3 Clinical Study With BLM-240 (Desflurane) (NCT NCT00762372)

Last Updated: 2019-03-08

Results Overview

The investigator or sub-investigator observed the patient for body movement (excluding bucking) during anesthetic maintenance.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

216 participants

Primary outcome timeframe

Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)

Results posted on

2019-03-08

Participant Flow

Participant milestones

Participant milestones
Measure	BLM 240 N2O Group Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	BLM 240 O2 Group Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (\>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	Sevoflurane Group Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
Overall Study STARTED	111	55	50
Overall Study COMPLETED	110	55	50
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	BLM 240 N2O Group Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	BLM 240 O2 Group Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (\>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	Sevoflurane Group Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
Overall Study Adverse Event	1	0	0

Baseline Characteristics

Japan Phase 2/3 Clinical Study With BLM-240 (Desflurane)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BLM 240 N2O Group n=111 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	BLM 240 O2 Group n=55 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (\>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	Sevoflurane Group n=50 Participants Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	Total n=216 Participants Total of all reporting groups
Age, Continuous	48.5 years STANDARD_DEVIATION 12.2 • n=5 Participants	47.4 years STANDARD_DEVIATION 13.6 • n=7 Participants	45.7 years STANDARD_DEVIATION 13.4 • n=5 Participants	47.2 years STANDARD_DEVIATION 11.5 • n=4 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	35 Participants n=7 Participants	31 Participants n=5 Participants	126 Participants n=4 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	20 Participants n=7 Participants	19 Participants n=5 Participants	90 Participants n=4 Participants
Race/Ethnicity, Customized Japan	111 participants n=5 Participants	55 participants n=7 Participants	50 participants n=5 Participants	216 participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)

Population: Full Analysis Set (FAS) - subjects assigned to treatment groups, excluding subjects with significant GCP violations (significant violations regarding informed consent and study procedures), subjects who did not receive the allocated study drug, subjects whose ASA status was not Class I, II, III, or subjects for whom no data were available.

The investigator or sub-investigator observed the patient for body movement (excluding bucking) during anesthetic maintenance.

Outcome measures

Outcome measures
Measure	BLM-240 Group n=166 Participants Cumulative summary of two BLM 240 treatment Arms, including N2O and O2.	BLM-240 N2O Group n=111 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	BLM-240 O2 Group n=55 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (\>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	Sevoflurane Group n=50 Participants Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
Number of Participants With Body Movement During Anesthetic Maintenance No	165 participants	111 participants	54 participants	50 participants
Number of Participants With Body Movement During Anesthetic Maintenance Yes	1 participants	0 participants	1 participants	0 participants

PRIMARY outcome

Timeframe: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)

Population: FAS

The investigator or sub-investigator observed the patient for the presence or absence of awakening during anesthetic maintenance and interviewed the patient on the day after surgery to confirm whether the patient has any memory during anesthetic maintenance.

Outcome measures

Outcome measures
Measure	BLM-240 Group n=166 Participants Cumulative summary of two BLM 240 treatment Arms, including N2O and O2.	BLM-240 N2O Group n=111 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	BLM-240 O2 Group n=55 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (\>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	Sevoflurane Group n=50 Participants Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
Number of Participants With Recall/Memory Issues During Anesthetic Maintenance No	165 participants	110 participants	55 participants	50 participants
Number of Participants With Recall/Memory Issues During Anesthetic Maintenance Yes	0 participants	0 participants	0 participants	0 participants
Number of Participants With Recall/Memory Issues During Anesthetic Maintenance Unevaluable	1 participants	1 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)

Population: FAS

Rescue medication includes vasopressors and depressors.

Outcome measures

Outcome measures
Measure	BLM-240 Group n=166 Participants Cumulative summary of two BLM 240 treatment Arms, including N2O and O2.	BLM-240 N2O Group n=111 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	BLM-240 O2 Group n=55 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (\>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	Sevoflurane Group n=50 Participants Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
Number of Participants Requiring Rescue Treatment During Anesthetic Maintenance No	120 participants	75 participants	45 participants	34 participants
Number of Participants Requiring Rescue Treatment During Anesthetic Maintenance Yes	46 participants	36 participants	10 participants	16 participants

PRIMARY outcome

Timeframe: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)

Population: FAS

"Rescue medication includes vasopressors and depressors. Percentage of observation points at which systolic pressure 80 to \<150 mmHg and heart rate 50 to \<100 bpm could be maintained "

Outcome measures

Outcome measures
Measure	BLM-240 Group n=166 Participants Cumulative summary of two BLM 240 treatment Arms, including N2O and O2.	BLM-240 N2O Group n=111 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	BLM-240 O2 Group n=55 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (\>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	Sevoflurane Group n=50 Participants Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
Number of Participants Not Receiving Rescue Treatment Whose Blood Pressure/Heart Rate Maintained Above/Below 70% <70%	9 participants	7 participants	2 participants	3 participants
Number of Participants Not Receiving Rescue Treatment Whose Blood Pressure/Heart Rate Maintained Above/Below 70% >=70%	111 participants	68 participants	43 participants	31 participants

PRIMARY outcome

Timeframe: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)

Population: FAS

Rescue medication includes vasopressors and depressors. Percentage of observation points at which no rescue treatment was judged to be required based on blood pressure/heart rate

Outcome measures

Outcome measures
Measure	BLM-240 Group n=166 Participants Cumulative summary of two BLM 240 treatment Arms, including N2O and O2.	BLM-240 N2O Group n=111 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	BLM-240 O2 Group n=55 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (\>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	Sevoflurane Group n=50 Participants Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
Number of Participants Receiving Rescue Treatment Whose Blood Pressure/Heart Rate Maintained Above/Below 70% <70%	0 participants	0 participants	0 participants	0 participants
Number of Participants Receiving Rescue Treatment Whose Blood Pressure/Heart Rate Maintained Above/Below 70% >=70%	46 participants	36 participants	10 participants	16 participants

PRIMARY outcome

Timeframe: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)

Population: FAS

Evaluation on the efficacy (ability) of BLM-240 as an anesthetic drug.

Outcome measures

Outcome measures
Measure	BLM-240 Group n=166 Participants Cumulative summary of two BLM 240 treatment Arms, including N2O and O2.	BLM-240 N2O Group n=111 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	BLM-240 O2 Group n=55 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (\>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	Sevoflurane Group n=50 Participants Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
Overall Assessment of Efficacy Excellent Ability	111 participants	68 participants	43 participants	31 participants
Overall Assessment of Efficacy Sufficient Ability	9 participants	7 participants	2 participants	3 participants
Overall Assessment of Efficacy Some Ability	44 participants	35 participants	9 participants	16 participants
Overall Assessment of Efficacy Insufficient Ability	1 participants	0 participants	1 participants	0 participants
Overall Assessment of Efficacy Inadequate	0 participants	0 participants	0 participants	0 participants
Overall Assessment of Efficacy Unevaluable	1 participants	1 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Day 1 (Post-Surgery, from end of study drug inhalation to extubation)

Population: FAS

Evaluation of Awakening/Recovery from Anesthesia from end of study drug inhalation to extubation. The patient was extubated when the following signs were observed:(1) clear consciousness, (2) ability to breathe spontaneously (minute ventilation \>=50 mL/kg/min), and (3) stable circulatory dynamics (systolic pressure: \>=100 mmHg).

Outcome measures

Outcome measures
Measure	BLM-240 Group n=166 Participants Cumulative summary of two BLM 240 treatment Arms, including N2O and O2.	BLM-240 N2O Group n=111 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	BLM-240 O2 Group n=55 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (\>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	Sevoflurane Group n=50 Participants Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
Time to Extubation	9.8 minutes Standard Deviation 5	10.1 minutes Standard Deviation 4.6	9.3 minutes Standard Deviation 5.7	14.8 minutes Standard Deviation 8.4

SECONDARY outcome

Timeframe: Day 1 (Post-Surgery, from the end of study drug inhalation to awakening)

Population: FAS

Time from the end of study drug inhalation. After the end of inhalation of the study drug, the investigator commanded the patient to open his/her eyes once every minute to check whether he/she awoke and recorded the time of awakening.

Outcome measures

Outcome measures
Measure	BLM-240 Group n=166 Participants Cumulative summary of two BLM 240 treatment Arms, including N2O and O2.	BLM-240 N2O Group n=111 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	BLM-240 O2 Group n=55 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (\>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	Sevoflurane Group n=50 Participants Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
Time to Awakening	6.8 minutes Standard Deviation 4	7.2 minutes Standard Deviation 3.7	6.2 minutes Standard Deviation 4.6	10.4 minutes Standard Deviation 5.5

SECONDARY outcome

Timeframe: Day 1 (Post-Surgery, after extubation)

Population: FAS

After extubation, the investigator called and asked the patient to state the birth date once every minute and recorded the time the patient could state the birth date. Time from the end of study drug inhalation.

Outcome measures

Outcome measures
Measure	BLM-240 Group n=166 Participants Cumulative summary of two BLM 240 treatment Arms, including N2O and O2.	BLM-240 N2O Group n=111 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	BLM-240 O2 Group n=55 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (\>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	Sevoflurane Group n=50 Participants Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
Time to Stating Birth Date	11.4 minutes Standard Deviation 5.4	11.8 minutes Standard Deviation 5.3	10.6 minutes Standard Deviation 5.6	16.2 minutes Standard Deviation 8.7

SECONDARY outcome

Timeframe: Day 1 (Post-Surgery, after extubation)

Population: FAS

Score includes a ranking of 0-2 (higher shows improvement) in activity, respiration, circulation, consciousness, and O2 saturation (SpO2). After extubation, the investigator observed the patient's condition every 5 minutes until the Aldrete score reached \>=8 and recorded the Aldrete scores at 5-minute intervals.

Outcome measures

Outcome measures
Measure	BLM-240 Group n=166 Participants Cumulative summary of two BLM 240 treatment Arms, including N2O and O2.	BLM-240 N2O Group n=111 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	BLM-240 O2 Group n=55 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (\>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	Sevoflurane Group n=50 Participants Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
Time to Reaching an Aldrete Score >=8 (Min)	13.6 minutes Standard Deviation 5.2	13.9 minutes Standard Deviation 4.8	13.1 minutes Standard Deviation 6	18.7 minutes Standard Deviation 8.4

SECONDARY outcome

Timeframe: Day 1 (Post-Surgery, from awakening to before extubation)

Population: FAS

"Clear consciousness" means that patients responded to investigator's command for physical movement such as "hold my finger tight."

Outcome measures

Outcome measures
Measure	BLM-240 Group n=166 Participants Cumulative summary of two BLM 240 treatment Arms, including N2O and O2.	BLM-240 N2O Group n=111 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	BLM-240 O2 Group n=55 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (\>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	Sevoflurane Group n=50 Participants Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
Time to Clear Consciousness	7.7 minutes Standard Deviation 4.4	8.1 minutes Standard Deviation 4.2	6.9 minutes Standard Deviation 4.7	12.3 minutes Standard Deviation 7.4

SECONDARY outcome

Timeframe: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)

Population: FAS

BIS is used to monitor depth of anesthesia. The BIS monitor provides a single number, which ranges from 0 (equivalent to EEG silence) to 100. A BIS value between 40 and 60 generally indicates an appropriate level for general anesthesia.

Outcome measures

Outcome measures
Measure	BLM-240 Group n=111 Participants Cumulative summary of two BLM 240 treatment Arms, including N2O and O2.	BLM-240 N2O Group n=55 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	BLM-240 O2 Group n=50 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (\>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	Sevoflurane Group Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
Changes in Bispectral Index (BIS) Over Time During Anethetic Maintenance Prior to start of inhalation	50.7 score on a scale Standard Deviation 13.2	48.6 score on a scale Standard Deviation 14.8	49.8 score on a scale Standard Deviation 12.6	—
Changes in Bispectral Index (BIS) Over Time During Anethetic Maintenance End of inhalation	46.3 score on a scale Standard Deviation 12.9	57.3 score on a scale Standard Deviation 18.6	48.8 score on a scale Standard Deviation 11.8	—
Changes in Bispectral Index (BIS) Over Time During Anethetic Maintenance After Awakening	84.8 score on a scale Standard Deviation 15.4	88.2 score on a scale Standard Deviation 10.8	87.4 score on a scale Standard Deviation 11.2	—
Changes in Bispectral Index (BIS) Over Time During Anethetic Maintenance Before Extubation	90.1 score on a scale Standard Deviation 11.9	90.8 score on a scale Standard Deviation 10.8	90.9 score on a scale Standard Deviation 9.9	—
Changes in Bispectral Index (BIS) Over Time During Anethetic Maintenance 5 minutes after extubation	93.5 score on a scale Standard Deviation 6.7	95.2 score on a scale Standard Deviation 5.3	93.4 score on a scale Standard Deviation 6.1	—

SECONDARY outcome

Timeframe: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)

Population: FAS

Rescue medication can include vasopressors and depressors.

Outcome measures

Outcome measures
Measure	BLM-240 Group n=166 Participants Cumulative summary of two BLM 240 treatment Arms, including N2O and O2.	BLM-240 N2O Group n=111 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	BLM-240 O2 Group n=55 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (\>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	Sevoflurane Group n=50 Participants Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
Number of Participants Requiring Rescue Medication Due to Rise in Blood Pressure or Heart Rate	6 participants	4 participants	2 participants	0 participants

SECONDARY outcome

Timeframe: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)

Population: FAS

Rescue medication can include vasopressors and depressors.

Outcome measures

Outcome measures
Measure	BLM-240 Group n=166 Participants Cumulative summary of two BLM 240 treatment Arms, including N2O and O2.	BLM-240 N2O Group n=111 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	BLM-240 O2 Group n=55 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (\>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	Sevoflurane Group n=50 Participants Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
Number of Participants Requiring Rescue Medication Due to Drop in Blood Pressure or Heart Rate	40 participants	32 participants	8 participants	16 participants

SECONDARY outcome

Timeframe: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)

Population: FAS

Rescue medication can include vasopressors and depressors.

Outcome measures

Outcome measures
Measure	BLM-240 Group n=166 Participants Cumulative summary of two BLM 240 treatment Arms, including N2O and O2.	BLM-240 N2O Group n=111 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	BLM-240 O2 Group n=55 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (\>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	Sevoflurane Group n=50 Participants Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
Number of Participants Requiring Rescue Medication Due to Arrhythmia	3 participants	1 participants	2 participants	0 participants

SECONDARY outcome

Timeframe: Day 1 [just before the start of inhalation of study drug, during anesthetic maintenance (every 5 minutes after the start of inhalation of study drug), at the end of inhalation of study drug, immediately after awakening, and just before extubation]

Population: FAS

Measurement by infrared absorption spectrometry. The concentrations of BLM-240 and sevoflurane at the start of inhalation were set at 3% and 1%,respectively (by vaporizer dial setting). Concentrations are monitored to determine which levels keep the patient in stable condition without requiring rescue treatment.

Outcome measures

Outcome measures
Measure	BLM-240 Group n=111 Participants Cumulative summary of two BLM 240 treatment Arms, including N2O and O2.	BLM-240 N2O Group n=55 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	BLM-240 O2 Group n=50 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (\>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	Sevoflurane Group Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
Range of End-Tidal Anesthetic Percent Concentrations During Anesthetic Maintenance Low Range	3 percentage	4 percentage	1.2 percentage	—
Range of End-Tidal Anesthetic Percent Concentrations During Anesthetic Maintenance High Range	4 percentage	5 percentage	1.4 percentage	—

SECONDARY outcome

Population: FAS

Measurement by infrared absorption spectrometry. Ranges reflecting when concentrations were stable. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).

Outcome measures

Outcome measures
Measure	BLM-240 Group n=166 Participants Cumulative summary of two BLM 240 treatment Arms, including N2O and O2.	BLM-240 N2O Group n=60 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	BLM-240 O2 Group Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (\>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	Sevoflurane Group Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
Range of Inspired Anesthetic Concentrations Below End-Tidal Anesthetic Percent Concentrations During Anesthetic Maintenance High Range	0.5 percentage	0.3 percentage	—	—
Range of Inspired Anesthetic Concentrations Below End-Tidal Anesthetic Percent Concentrations During Anesthetic Maintenance Low Range	0.3 percentage	0.1 percentage	—	—

SECONDARY outcome

Population: FAS

Successfully maintaining anesthesia is defined as keeping the patient in stable condition (systolic pressure 80 to \<150 mmHg and heart rate 50 to \<100bpm) without requiring rescue treatment or additional dose of opioid analgesics (\<=2 ug/kg/hr).If patient was found to have body movement, recall, or memory during anesthetic maintenance, data for such patient were to be excluded from summary statistic calculation.

Outcome measures

Outcome measures
Measure	BLM-240 Group n=166 Participants Cumulative summary of two BLM 240 treatment Arms, including N2O and O2.	BLM-240 N2O Group n=111 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	BLM-240 O2 Group n=55 Participants Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (\>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).	Sevoflurane Group n=50 Participants Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
End-Tidal Anesthetic Percent Concentrations Successfully Maintained Anesthesia	3.97 percentage Standard Deviation 1.17	3.69 percentage Standard Deviation 1.06	4.48 percentage Standard Deviation 1.21	1.30 percentage Standard Deviation 0.39

Adverse Events

BLM 240 Group

Serious events: 0 serious events

Other events: 163 other events

Deaths: 0 deaths

BLM 240 N2O Group

Serious events: 5 serious events

Other events: 108 other events

Deaths: 0 deaths

BLM 240 O2 Group

Serious events: 0 serious events

Other events: 55 other events

Deaths: 0 deaths

Sevoflurane Group

Serious events: 2 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BLM 240 Group n=166 participants at risk	BLM 240 N2O Group n=111 participants at risk	BLM 240 O2 Group n=55 participants at risk	Sevoflurane Group n=50 participants at risk
Nervous system disorders Altered state of consciousness	0.00% 0/166 • 3 Days before study drug through 7 days after surgery.	0.90% 1/111 • Number of events 1 • 3 Days before study drug through 7 days after surgery.	0.00% 0/55 • 3 Days before study drug through 7 days after surgery.	0.00% 0/50 • 3 Days before study drug through 7 days after surgery.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/166 • 3 Days before study drug through 7 days after surgery.	1.8% 2/111 • Number of events 2 • 3 Days before study drug through 7 days after surgery.	0.00% 0/55 • 3 Days before study drug through 7 days after surgery.	0.00% 0/50 • 3 Days before study drug through 7 days after surgery.
Injury, poisoning and procedural complications Suture rupture	0.00% 0/166 • 3 Days before study drug through 7 days after surgery.	0.90% 1/111 • Number of events 1 • 3 Days before study drug through 7 days after surgery.	0.00% 0/55 • 3 Days before study drug through 7 days after surgery.	0.00% 0/50 • 3 Days before study drug through 7 days after surgery.
Infections and infestations Pyelonephritis	0.00% 0/166 • 3 Days before study drug through 7 days after surgery.	0.90% 1/111 • Number of events 1 • 3 Days before study drug through 7 days after surgery.	0.00% 0/55 • 3 Days before study drug through 7 days after surgery.	0.00% 0/50 • 3 Days before study drug through 7 days after surgery.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/166 • 3 Days before study drug through 7 days after surgery.	0.90% 1/111 • Number of events 1 • 3 Days before study drug through 7 days after surgery.	0.00% 0/55 • 3 Days before study drug through 7 days after surgery.	0.00% 0/50 • 3 Days before study drug through 7 days after surgery.
Cardiac disorders Cardiac arrest	0.00% 0/166 • 3 Days before study drug through 7 days after surgery.	0.90% 1/111 • Number of events 1 • 3 Days before study drug through 7 days after surgery.	0.00% 0/55 • 3 Days before study drug through 7 days after surgery.	0.00% 0/50 • 3 Days before study drug through 7 days after surgery.
Nervous system disorders Loss of consciousness	0.00% 0/166 • 3 Days before study drug through 7 days after surgery.	0.90% 1/111 • Number of events 1 • 3 Days before study drug through 7 days after surgery.	0.00% 0/55 • 3 Days before study drug through 7 days after surgery.	0.00% 0/50 • 3 Days before study drug through 7 days after surgery.
Infections and infestations Pneumonia	0.00% 0/166 • 3 Days before study drug through 7 days after surgery.	0.00% 0/111 • 3 Days before study drug through 7 days after surgery.	0.00% 0/55 • 3 Days before study drug through 7 days after surgery.	4.0% 2/50 • Number of events 2 • 3 Days before study drug through 7 days after surgery.
Investigations Haematocrit decreased	0.00% 0/166 • 3 Days before study drug through 7 days after surgery.	0.00% 0/111 • 3 Days before study drug through 7 days after surgery.	0.00% 0/55 • 3 Days before study drug through 7 days after surgery.	2.0% 1/50 • Number of events 1 • 3 Days before study drug through 7 days after surgery.
Investigations Haemoglobin decreased	0.00% 0/166 • 3 Days before study drug through 7 days after surgery.	0.00% 0/111 • 3 Days before study drug through 7 days after surgery.	0.00% 0/55 • 3 Days before study drug through 7 days after surgery.	2.0% 1/50 • Number of events 1 • 3 Days before study drug through 7 days after surgery.

Other adverse events

Additional Information

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Principal investigator is a sponsor employee
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