Trial Outcomes & Findings for Anesthesia and Lymphocytes Apoptosis (NCT NCT01461551)

Results Overview

Blood samples were obtained 24 h after the surgery for routine blood examination. This analysis was performed in the hospital laboratory using routine laboratory procedures.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

105 participants

Primary outcome timeframe

1 day after surgery

Results posted on

2015-05-22

Participant Flow

Patient recruitment took place from October 9, 2011 to January 12, 2012 in Ruijin Hospital. A total of 149 patients scheduled to undergo elective OPCABG surgery were assessed for eligibility, with 105 patients enrolled and allocated randomly.

A total of 105 patients enrolled and allocated randomly. Five of these patients were excluded after enrollment (four due to changes in surgical schedules, and one due to severe hemodynamic instability during clamping of the coronary artery and requiring cardiopulmonary bypass).

Participant milestones

Participant milestones
Measure	Sevoflurane Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)	Propofol Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)	Combine of Sevoflurane and Propofol combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
Overall Study STARTED	35	35	35
Overall Study COMPLETED	33	34	33
Overall Study NOT COMPLETED	2	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Sevoflurane Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)	Propofol Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)	Combine of Sevoflurane and Propofol combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
Overall Study Physician Decision	2	1	2

Baseline Characteristics

Anesthesia and Lymphocytes Apoptosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sevoflurane n=33 Participants Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)	Propofol n=34 Participants Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)	Combine of Sevoflurane and Propofol n=33 Participants combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)	Total n=100 Participants Total of all reporting groups
Age, Continuous	61 years STANDARD_DEVIATION 8 • n=99 Participants	62 years STANDARD_DEVIATION 8 • n=107 Participants	65 years STANDARD_DEVIATION 9 • n=206 Participants	63 years STANDARD_DEVIATION 8 • n=7 Participants
Sex: Female, Male Female	33 Participants n=99 Participants	34 Participants n=107 Participants	33 Participants n=206 Participants	100 Participants n=7 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Region of Enrollment China	33 participants n=99 Participants	34 participants n=107 Participants	33 participants n=206 Participants	100 participants n=7 Participants

PRIMARY outcome

Timeframe: 1 day after surgery

Blood samples were obtained 24 h after the surgery for routine blood examination. This analysis was performed in the hospital laboratory using routine laboratory procedures.

Outcome measures

Outcome measures
Measure	Sevoflurane n=33 Participants Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)	Propofol n=34 Participants Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)	Combine of Sevoflurane and Propofol n=33 Participants combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
Lymphocyte Count	0.55 cells/nanoliter Standard Deviation 0.25	0.73 cells/nanoliter Standard Deviation 0.27	0.73 cells/nanoliter Standard Deviation 0.31

SECONDARY outcome

Timeframe: participants will stay in intensive care unit after surgery, an expected average of 2 days

Outcome measures

Outcome data not reported

Adverse Events

Sevoflurane

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Propofol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Combine of Sevoflurane and Propofol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lijie Jia

Ruijin Hospital

Phone: 13916667704

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place