Trial Outcomes & Findings for Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery (NCT NCT01294163)

NCT ID: NCT01294163

Last Updated: 2015-12-21

Results Overview

Blood level of troponin I measured by a central laboratory

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

509 participants

Primary outcome timeframe

Sampling performed 24 hours after the end of the surgical procedure

Results posted on

2015-12-21

Participant Flow

A total of 542 patients were enrolled (509 met the inclusion criteria) from 17 centres in 4 countries; 8 sites in France, 6 sites in Germany, 1 site in Italy and 2 sites in The Netherlands. Date of first enrolment: 20 April 2011 Date of last completed: 05 April 2014

Participant milestones

Participant milestones
Measure	Xenon Including Pilot Patients Anesthetic agent before and after CPB: xenon	Sevoflurane Anesthetic agent before and after CPB: sevoflurane	TIVA Anesthetic agent before and after CPB: propofol
Overall Study STARTED	178	165	166
Overall Study COMPLETED	177	165	163
Overall Study NOT COMPLETED	1	0	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Xenon n=161 Participants Anesthetic agent before and after CPB: xenon	Sevoflurane n=165 Participants Anesthetic agent before and after CPB: sevoflurane	TIVA n=166 Participants Anesthetic agent before and after CPB: propofol	Total n=492 Participants Total of all reporting groups
Age, Continuous	64.66 years STANDARD_DEVIATION 9.12 • n=5 Participants	63.86 years STANDARD_DEVIATION 8.66 • n=7 Participants	63.89 years STANDARD_DEVIATION 9.40 • n=5 Participants	64.14 years STANDARD_DEVIATION 9.06 • n=4 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	25 Participants n=7 Participants	20 Participants n=5 Participants	64 Participants n=4 Participants
Sex: Female, Male Male	142 Participants n=5 Participants	140 Participants n=7 Participants	146 Participants n=5 Participants	428 Participants n=4 Participants
Region of Enrollment Netherlands	12 participants n=5 Participants	11 participants n=7 Participants	11 participants n=5 Participants	34 participants n=4 Participants
Region of Enrollment Italy	3 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	11 participants n=4 Participants
Region of Enrollment France	89 participants n=5 Participants	93 participants n=7 Participants	93 participants n=5 Participants	275 participants n=4 Participants
Region of Enrollment Germany	57 participants n=5 Participants	57 participants n=7 Participants	58 participants n=5 Participants	172 participants n=4 Participants
BMI	27.65 kg/m² STANDARD_DEVIATION 3.64 • n=5 Participants	27.21 kg/m² STANDARD_DEVIATION 3.68 • n=7 Participants	27.78 kg/m² STANDARD_DEVIATION 4.00 • n=5 Participants	27.55 kg/m² STANDARD_DEVIATION 3.78 • n=4 Participants

PRIMARY outcome

Timeframe: Sampling performed 24 hours after the end of the surgical procedure

Population: The primary analysis was a non-inferiority comparison between Xenon and Sevoflurane and was performed on the Per Protocol (PP) Set composed of all randomised and treated patients with no major protocol deviations during the study.

Blood level of troponin I measured by a central laboratory

Outcome measures

Outcome measures
Measure	Xenon n=146 Participants Anesthetic agent before and after CPB: xenon	Sevoflurane n=151 Participants Anesthetic agent before and after CPB: sevoflurane
Blood Level of Troponin I	2.16 ng/mL Interval 1.54 to 2.78	2.57 ng/mL Interval 1.96 to 3.18

PRIMARY outcome

Timeframe: Sampling performed 24 hours after the end of the surgical procedure

Population: The non-inferiority comparison between Xenon and Sevoflurane was repeated using log-transformed blood troponin levels on the PP Set.

Blood level of troponin I measured by a central laboratory

Outcome measures

Outcome measures
Measure	Xenon n=146 Participants Anesthetic agent before and after CPB: xenon	Sevoflurane n=151 Participants Anesthetic agent before and after CPB: sevoflurane
Log-transformed Blood Level of Troponin I	0.30 ng/mL Interval 0.15 to 0.44	0.39 ng/mL Interval 0.25 to 0.54

SECONDARY outcome

Timeframe: 4 hours

On-line monitoring of depth of anaesthesia from bi-spectral electroencephalogram analysis (BIS monitor)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 hours

Arterial blood gases

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 hours

Monitoring of heart rate, arterial blood pressure, central venous pressure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days

Confusion Assessment Method

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days

Outcome measures

Outcome data not reported

Adverse Events

Xenon Including Pilot Patients

Serious events: 30 serious events

Other events: 154 other events

Deaths: 0 deaths

Sevoflurane

Serious events: 24 serious events

Other events: 139 other events

Deaths: 0 deaths

TIVA

Serious events: 26 serious events

Other events: 143 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Jan HOFLAND

Radboudumc, Department of Anaesthesiology

Phone: +31243611111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	Xenon Including Pilot Patients n=178 participants at risk Anesthetic agent before and after CPB: xenon	Sevoflurane n=165 participants at risk Anesthetic agent before and after CPB: sevoflurane	TIVA n=166 participants at risk Anesthetic agent before and after CPB: propofol
Cardiac disorders Atrial fibrillation	30.9% 55/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	26.1% 43/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	22.3% 37/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
Cardiac disorders Tachycardia	7.9% 14/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	4.2% 7/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	8.4% 14/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
Cardiac disorders Bradycardia	6.7% 12/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	5.5% 9/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	7.8% 13/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
Cardiac disorders Pericardial effusion	5.1% 9/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	2.4% 4/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	3.0% 5/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
Vascular disorders Hypotension	30.9% 55/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	38.2% 63/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	33.1% 55/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
Vascular disorders Hypertension	21.9% 39/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	16.4% 27/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	22.3% 37/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
Gastrointestinal disorders Nausea	12.9% 23/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	11.5% 19/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	10.8% 18/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
Gastrointestinal disorders Constipation	9.6% 17/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	9.1% 15/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	9.6% 16/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
Gastrointestinal disorders Vomiting	9.6% 17/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	5.5% 9/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	7.8% 13/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
General disorders Oedema peripheral	10.7% 19/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	9.1% 15/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	10.2% 17/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
General disorders Pain	8.4% 15/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	5.5% 9/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	9.6% 16/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
General disorders Pyrexia	7.3% 13/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	12.1% 20/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	3.6% 6/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
Metabolism and nutrition disorders Hyperglycaemia	16.3% 29/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	14.5% 24/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	7.2% 12/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
Metabolism and nutrition disorders Hypovolaemia	7.3% 13/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	7.9% 13/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	7.2% 12/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
Metabolism and nutrition disorders Hypokalaemia	6.2% 11/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	6.1% 10/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	3.6% 6/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
Investigations Electrocardiogram ST Segment Elevation	10.1% 18/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	13.3% 22/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	7.8% 13/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
Investigations Troponin increased	5.6% 10/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	7.9% 13/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	6.6% 11/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
Investigations Troponin T increased	5.1% 9/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	6.7% 11/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	9.0% 15/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
Investigations Bispectral index decreased	5.1% 9/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	0.00% 0/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	0.00% 0/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
Respiratory, thoracic and mediastinal disorders Hypoxia	7.9% 14/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	9.1% 15/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	8.4% 14/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.6% 10/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	4.8% 8/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	6.0% 10/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
Respiratory, thoracic and mediastinal disorders Productive cough	5.1% 9/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	2.4% 4/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	4.2% 7/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
Blood and lymphatic system disorders Anaemia	16.3% 29/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	20.0% 33/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	18.1% 30/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
Injury, poisoning and procedural complications Post procedural haemorrhage	6.7% 12/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	7.3% 12/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	6.0% 10/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
Injury, poisoning and procedural complications Insomnia	3.9% 7/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	5.5% 9/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	2.4% 4/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
Renal and urinary disorders Oliguria	10.7% 19/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	10.3% 17/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	9.0% 15/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set
Psychiatric disorders Anxiety	5.1% 9/178 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	6.1% 10/165 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set	3.6% 6/166 • Adverse Events observed from the start of study treatment up to 30 days. Participants at risk are the patients from the safety set