Trial Outcomes & Findings for The Effect of Thoracic Epidural Anesthesia With Different Block Level on Propofol Induction (NCT NCT02135016)

Results Overview

The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

45 participants

Primary outcome timeframe

The participants will be followed for the duration of anesthesia induction, an expected average of half an hour

Results posted on

2014-08-29

Participant Flow

Participant milestones

Participant milestones
Measure	1% Lidocaine epidural anesthesia with 1% lidocaine 10ml before propofol TCI	2% Lidocaine epidural anesthesia with 2% lidocaine 5ml before propofol TCI	0.9% Normal Saline epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
Overall Study STARTED	15	15	15
Overall Study COMPLETED	15	15	15
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Thoracic Epidural Anesthesia With Different Block Level on Propofol Induction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1% Lidocaine n=15 Participants epidural anesthesia with 1% lidocaine 10ml before propofol TCI	2% Lidocaine n=15 Participants epidural anesthesia with 2% lidocaine 5ml before propofol TCI	0.9% Normal Saline n=15 Participants epidural anesthesia with 0.9% normal saline 5ml before propofol TCI	Total n=45 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 6 • n=5 Participants	57 years STANDARD_DEVIATION 7.0 • n=7 Participants	56 years STANDARD_DEVIATION 4 • n=5 Participants	56 years STANDARD_DEVIATION 6 • n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	20 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	25 Participants n=4 Participants

PRIMARY outcome

Timeframe: The participants will be followed for the duration of anesthesia induction, an expected average of half an hour

The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia.

Outcome measures

Outcome measures
Measure	1% Lidocaine n=15 Participants epidural anesthesia with 1% lidocaine 10ml before propofol TCI	2% Lidocaine n=15 Participants epidural anesthesia with 2% lidocaine 5ml before propofol TCI	0.9% Normal Saline n=15 Participants epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
The Effect-site Concentration of Propofol	1.51 µg/ml Standard Deviation 0.44	1.99 µg/ml Standard Deviation 0.37	2.68 µg/ml Standard Deviation 0.68

SECONDARY outcome

Timeframe: The participants will be followed for the duration of anesthesia induction, an expected average of half an hour

The bispectral index (BIS) of each patient will be recorded at four different time points,as follows, baseline(the awake phase before epidural anesthesia),10 mins after epidural anesthesia, 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia). BIS values varies from 0 to 100(0, no cerebral activity; 40 to 60, general anesthesia; 60 to 85, sedated; 85 to 100, awake).

Outcome measures

Outcome measures
Measure	1% Lidocaine n=15 Participants epidural anesthesia with 1% lidocaine 10ml before propofol TCI	2% Lidocaine n=15 Participants epidural anesthesia with 2% lidocaine 5ml before propofol TCI	0.9% Normal Saline n=15 Participants epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
The Bispectral Index Baseline	95.4 units on a scale Standard Deviation 1.4	95.4 units on a scale Standard Deviation 1.4	95.7 units on a scale Standard Deviation 1.3
The Bispectral Index 10mins after epidural aneasthesia	85.3 units on a scale Standard Deviation 0.7	85.1 units on a scale Standard Deviation 1.3	94.5 units on a scale Standard Deviation 0.9
The Bispectral Index 20mins after epidural aneasthesia	84.6 units on a scale Standard Deviation 0.9	83.8 units on a scale Standard Deviation 0.8	94.9 units on a scale Standard Deviation 1.8
The Bispectral Index Loss of consciousness	65.7 units on a scale Standard Deviation 0.8	65.3 units on a scale Standard Deviation 2.5	66.1 units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: The participants will be followed for the duration of anesthesia induction, an expected average of half an hour

The mean arterial pressure of each patient will be recorded at four different time points, as follows, baseline(the awake phase before epidural anesthesia), 10 mins after epidural anesthesia, 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia).

Outcome measures

Outcome measures
Measure	1% Lidocaine n=15 Participants epidural anesthesia with 1% lidocaine 10ml before propofol TCI	2% Lidocaine n=15 Participants epidural anesthesia with 2% lidocaine 5ml before propofol TCI	0.9% Normal Saline n=15 Participants epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
The Mean Blood Pressure Baseline	95.4 mmHg Standard Deviation 2.5	95.1 mmHg Standard Deviation 2.1	95.9 mmHg Standard Deviation 2.3
The Mean Blood Pressure 10mins after epidural aneasthesia	85.9 mmHg Standard Deviation 3.6	83.7 mmHg Standard Deviation 2.6	95.5 mmHg Standard Deviation 2.7
The Mean Blood Pressure 20mins after epidural aneasthesia	79.3 mmHg Standard Deviation 2.5	80.5 mmHg Standard Deviation 3.0	96.1 mmHg Standard Deviation 2.2
The Mean Blood Pressure Loss of consciousness	74.0 mmHg Standard Deviation 1.4	74.5 mmHg Standard Deviation 1.0	82.7 mmHg Standard Deviation 1.3

SECONDARY outcome

Timeframe: The participants will be followed for the duration of anesthesia induction, an expected average of half an hour

The heart rate of each patient will be recorded at three different four points, as follows, baseline(the awake phase before epidural anesthesia), 10mins after epidural anesthesia, 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia).

Outcome measures

Outcome measures
Measure	1% Lidocaine n=15 Participants epidural anesthesia with 1% lidocaine 10ml before propofol TCI	2% Lidocaine n=15 Participants epidural anesthesia with 2% lidocaine 5ml before propofol TCI	0.9% Normal Saline n=15 Participants epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
The Heart Rate Baseline	71.4 beats per minute Standard Deviation 4.7	72.8 beats per minute Standard Deviation 3.3	71.3 beats per minute Standard Deviation 3.5
The Heart Rate 10mins after epidural aneasthesia	69.8 beats per minute Standard Deviation 4.4	69.2 beats per minute Standard Deviation 3.7	71.3 beats per minute Standard Deviation 3.5
The Heart Rate 20mins after epidural aneasthesia	68.5 beats per minute Standard Deviation 3.4	67.2 beats per minute Standard Deviation 3.4	70.3 beats per minute Standard Deviation 3.3
The Heart Rate Loss of consciousness	63.2 beats per minute Standard Deviation 1.8	62.3 beats per minute Standard Deviation 1.9	63.2 beats per minute Standard Deviation 1.8

SECONDARY outcome

Timeframe: 20 mins after epidural anesthesia

The block level 20mins after epidural anesthesia and it is verified by the loss of sensation to alcohol swab before target controlled infusion of propofol.It is the number of block segments.The block level varies from 0 to 10(0, no block level; 1 to 5, narrow block level;6 to 10, wide block level).

Outcome measures

Outcome measures
Measure	1% Lidocaine n=15 Participants epidural anesthesia with 1% lidocaine 10ml before propofol TCI	2% Lidocaine n=15 Participants epidural anesthesia with 2% lidocaine 5ml before propofol TCI	0.9% Normal Saline n=15 Participants epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
The Block Level of Epidural Anesthesia	6.5 units on a scale Standard Deviation 1.0	4.2 units on a scale Standard Deviation 0.9	0 units on a scale Standard Deviation 0

Adverse Events

Group A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group C

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. Jun Wang

First Hospital of CMU

Phone: 8602483283100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place