Trial Outcomes & Findings for Target-Controlled Infusion of Propofol for Flexible Bronchoscopy Sedation (NCT NCT01101477)

Results Overview

Hypoxemia is defined as: Oxyhemoglobin saturation (SPO2) is less than 90 % with any duration

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

144 participants

Primary outcome timeframe

During sedative induction and bronchoscopy

Results posted on

2011-12-08

Participant Flow

Patients undergoing elective flexible bronchoscopy (FB) and sedation were screened for enrolment at the bronchoscopic room on the day of exam.

If patients or accompanying family refused to paticipate anytime before assignment to groups.

Participant milestones

Participant milestones
Measure	Titration by Target Effect Site Concentration (Cet) 0.5μg/ml The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.	Titration by Cet 0.2μg/ml The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.	Titration by Cet 0.1μg/ml The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
Overall Study STARTED	49	49	46
Overall Study COMPLETED	44	46	45
Overall Study NOT COMPLETED	5	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Titration by Target Effect Site Concentration (Cet) 0.5μg/ml The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.	Titration by Cet 0.2μg/ml The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.	Titration by Cet 0.1μg/ml The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
Overall Study Protocol Violation	5	3	1

Baseline Characteristics

Target-Controlled Infusion of Propofol for Flexible Bronchoscopy Sedation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Titration by Target Effect Site Concentration (Cet) 0.5μg/ml n=49 Participants The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.	Titration by Cet 0.2μg/ml n=49 Participants The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.	Titration by Cet 0.1μg/ml n=46 Participants The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.	Total n=144 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=93 Participants	28 Participants n=4 Participants	21 Participants n=27 Participants	76 Participants n=483 Participants
Age, Categorical >=65 years	22 Participants n=93 Participants	21 Participants n=4 Participants	25 Participants n=27 Participants	68 Participants n=483 Participants
Age Continuous	61.4 years STANDARD_DEVIATION 13.0 • n=93 Participants	62.6 years STANDARD_DEVIATION 13.5 • n=4 Participants	63.4 years STANDARD_DEVIATION 14.4 • n=27 Participants	62.4 years STANDARD_DEVIATION 13.6 • n=483 Participants
Sex: Female, Male Female	23 Participants n=93 Participants	22 Participants n=4 Participants	22 Participants n=27 Participants	67 Participants n=483 Participants
Sex: Female, Male Male	26 Participants n=93 Participants	27 Participants n=4 Participants	24 Participants n=27 Participants	77 Participants n=483 Participants
Region of Enrollment Taiwan	49 participants n=93 Participants	49 participants n=4 Participants	46 participants n=27 Participants	144 participants n=483 Participants

PRIMARY outcome

Timeframe: During sedative induction and bronchoscopy

Population: The participants who received intervention completely were analyzed.

Hypoxemia is defined as: Oxyhemoglobin saturation (SPO2) is less than 90 % with any duration

Outcome measures

Outcome measures
Measure	Titration by Target Effect Site Concentration (Cet) 0.5μg/ml n=44 Participants The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.	Titration by Cet 0.2μg/ml n=46 Participants The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.	Titration by Cet 0.1μg/ml n=45 Participants The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
The Number of Patients With Hypoxemia During Flexible Bronchoscopy	29 participants	22 participants	18 participants

PRIMARY outcome

Timeframe: During sedative induction and bronchoscopy

The investigator will titrate the target effect site concentration (Cet) during bronchoscopy according to protocol to keep stable vital signs and sedative levels. The numbers of adjustment will be recorded to show which regimen required less adjustment to keep stable sedative levels and vital signs.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: after bronchosocpy

The recovery time to orientation was defined as the time between finishing bronchoscopy to the time when the patients could spontaneously open their eyes, recall their date of birth, and correctly perform finger-nose test.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: after bronchoscopy

The dosses of propofol used during induction and overall flexible bronchoscopy will be recored from the screen of the TCI pump.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After bronchoscopy

After the bronchoscopy, the bronchoscopist will be asked by 10-point Verbal Analogus Scale (0: the best cooperation, 10: the worst cooperation) to express how they fell about the cooperation of patients undergoing the bronchoscopy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After recovery

After the recovery, patients will be asked about the tolerance of bronchoscopy performed to them by 10-point Verbal Analogus Scale (0: best tolerance, 10: worst tolerance)

Outcome measures

Outcome data not reported

Adverse Events

Titration by Target Effect Site Concentration (Cet) 0.5μg/ml

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Titration by Cet 0.2μg/ml

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Titration by Cet 0.1μg/ml

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Titration by Target Effect Site Concentration (Cet) 0.5μg/ml n=44 participants at risk The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.	Titration by Cet 0.2μg/ml n=46 participants at risk The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.	Titration by Cet 0.1μg/ml n=45 participants at risk The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
Respiratory, thoracic and mediastinal disorders oxyhemoglobin saturation (SpO2) less than 80%	13.6% 6/44 • From the starting of induction to patients leaving the bronchoscopic room after recovery.	2.2% 1/46 • From the starting of induction to patients leaving the bronchoscopic room after recovery.	4.4% 2/45 • From the starting of induction to patients leaving the bronchoscopic room after recovery.

Additional Information

Dr. Ting-Yu Lin

Chang Gung Memorial Hospital

Phone: 886 3 3281200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place