Trial Outcomes & Findings for Hemodynamic Responses During Induction: Comparison of Marsh and Schnider Pharmacokinetic Models (NCT NCT01759160)

Results Overview

After propofol infusion started, according to sedation level, TCI targets were gradually titrated to reach a state of equilibrium at the end of the first 25 minutes. SVI were continuously monitored, at the end of the first 25 minutes, value change from baseline level were calculated.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

The end of the first 25 minutes after propofol infusion

Results posted on

2013-03-29

Participant Flow

The recruitment process started from Dec. 2012, ended in Jan.2013. Study location is The First Affiliated Hospital of Sun Yat-sen University.

enrolled participants were excluded when they were found allergic to drugs used during the study.

Participant milestones

Participant milestones
Measure	Marsh Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.	Schnider Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hemodynamic Responses During Induction: Comparison of Marsh and Schnider Pharmacokinetic Models

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Marsh n=30 Participants Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.	Schnider n=30 Participants Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	40.1 years STANDARD_DEVIATION 13.1 • n=5 Participants	41.6 years STANDARD_DEVIATION 10.6 • n=7 Participants	40.9 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment China	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: The end of the first 25 minutes after propofol infusion

After propofol infusion started, according to sedation level, TCI targets were gradually titrated to reach a state of equilibrium at the end of the first 25 minutes. SVI were continuously monitored, at the end of the first 25 minutes, value change from baseline level were calculated.

Outcome measures

Outcome measures
Measure	Marsh n=30 Participants Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.	Schnider n=30 Participants Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
SVI (Stroke Volume Index) Value Change From Baseline Level at the End of the First 25 Minutes.	-31.1 ml/beat/m^2 Standard Deviation 9.8	-31.7 ml/beat/m^2 Standard Deviation 9.9

SECONDARY outcome

Timeframe: 25 minutes after propofol infusion

Narcotrend was utilized to continuously record patients' sedation level during induction, provided as a criteria for Cpt (Plasma Target Concentration) adjustment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 25 minutes after induction

CVP was continuously monitored to assess preload condition and served to calculate SVRI (systemic vascular resistance index) every minute during the first 25 minutes of infusion.

Outcome measures

Outcome data not reported

Adverse Events

Marsh

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Schnider

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Marsh n=30 participants at risk Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.	Schnider n=30 participants at risk Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
Cardiac disorders Cardiac Arrhythmia	0.00% 0/30	0.00% 0/30

Other adverse events

Other adverse events
Measure	Marsh n=30 participants at risk Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.	Schnider n=30 participants at risk Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
Cardiac disorders Hypotension (Systolic blood pressure lower than 75mmHg)	0.00% 0/30	0.00% 0/30

Additional Information

Dr. Xia Feng

First Affiliated Hospital of Sun Yat-sen University

Phone: 008613688877856

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place