Trial Outcomes & Findings for Alternative Sedation During Bronchoscopy (NCT NCT01158820)

Results Overview

An initial baseline minute ventilation estimate was obtained via calibrated respiratory impedance plethysmography bands. Subsequent minute ventilation was normalized to this value. Values exceeding 100% were excluded from analysis, as these typically reflected a period of hyperpnea subsequent to relief of airway obstruction by chin lift or jaw thrust.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

During the bronchoscopy procedure only, 58.5 minutes average

Results posted on

2019-02-26

Participant Flow

Patients were recruited from the practices of the pulmonologist sub investigators by the principal investigator

Participant milestones

Participant milestones
Measure	Placebo 1. Nebulized lidocaine 2% (maximum dose 200 mg) will be administered for 20 minutes. 2. Following nebulization, syringe A (placebo) will be given at a rate of 1 µg/kg (based on a concentration of 4 µg/ml) for 10 minutes. Supplemental topical anesthesia will be administered by the pulmonologist during this time. 3. After step 2, syringe B (midazolam 2 mg and fentanyl 50 µg) will be administered by the anesthesiologist. The infusion rate of syringe A (placebo) will be decreased to 0.7 µg/kg/hr. Syringe C (placebo) will be infused at 4 µg/kg/min (based on 10 mg/ml concentration) 4. Boluses of 0.5 mg midazolam and 12.5 µg fentanyl will be administered by the pulmonologist from syringe D as needed for patient comfort. Syringe E (benadryl 25 mg) will be administered in entirety by the anesthesiologist after the 6th and 16th bolus of midazolam/fentanyl. placebo + Standard of Care of midazolam and fentanyl: Control Saline 50 ml Midazolam 2 mg + Fentanyl 50 µg Saline 20 ml Midazolam 1	Dexmedetomidine and Ketamine 1. Nebulized lidocaine 2% (maximum dose 200 mg) will be administered for 20 minutes. 2. Following nebulization, syringe A (dexmedetomidine) will be given at a rate of 1 µg/kg (based on a concentration of 4 µg/ml) for 10 minutes. Supplemental topical anesthesia will be administered by the pulmonologist during this time. 3. After step 2, syringe B (ketamine 30 mg) will be administered by the anesthesiologist. The infusion rate of syringe A (dexmedetomidine) will be decreased to 0.7 µg/kg/hr. Syringe C (ketamine) will be infused at 4 µg/kg/min (based on 10 mg/ml concentration) 4. Boluses of 0.5 mg midazolam and 12.5 µg fentanyl will be administered by the pulmonologist from syringe D as needed for patient comfort. Syringe E (benadryl 25 mg) will be administered in entirety by the anesthesiologist after the 6th and 16th bolus of midazolam/fentanyl. dexmedetomidine and ketamine Study Medication: Experimental Dexmedetomidine 200 µg in 50 ml Ketamine 30 mg Ketamine 200 mg in 20 ml M
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alternative Sedation During Bronchoscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=25 Participants Placebo + Standard of Care of midazolam and fentanyl	Dexmedetomidine and Ketamine n=25 Participants dexmedetomidine and ketamine + Standard of Care of midazolam and fentanyl	Total n=50 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	25 Participants n=5 Participants	25 Participants n=7 Participants	50 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	59.4 years STANDARD_DEVIATION 13.2 • n=5 Participants	61.2 years STANDARD_DEVIATION 14.9 • n=7 Participants	59.88 years STANDARD_DEVIATION 15.86 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	19 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: During the bronchoscopy procedure only, 58.5 minutes average

An initial baseline minute ventilation estimate was obtained via calibrated respiratory impedance plethysmography bands. Subsequent minute ventilation was normalized to this value. Values exceeding 100% were excluded from analysis, as these typically reflected a period of hyperpnea subsequent to relief of airway obstruction by chin lift or jaw thrust.

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Placebo + Standard of Care of midazolam and fentanyl	Dexmedetomidine and Ketamine n=25 Participants dexmedetomidine and ketamine + Standard of Care (Midazolam + fentanyl)
Decreased Minute Ventilation	0.736 percentage of baseline Interval 0.592 to 0.848	0.764 percentage of baseline Interval 0.592 to 0.891

PRIMARY outcome

Timeframe: During the bronchoscopy procedure only, 58.5 minutes average

Total fentanyl dose delivered during the procedure

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Placebo + Standard of Care of midazolam and fentanyl	Dexmedetomidine and Ketamine n=25 Participants dexmedetomidine and ketamine + Standard of Care (Midazolam + fentanyl)
Total Fentanyl	112.5 µg Interval 87.5 to 188.4	68.75 µg Interval 21.9 to 103.1

PRIMARY outcome

Timeframe: Duration of procedure

Total midazolam delivered during procedure

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Placebo + Standard of Care of midazolam and fentanyl	Dexmedetomidine and Ketamine n=25 Participants dexmedetomidine and ketamine + Standard of Care (Midazolam + fentanyl)
Total Midazolam	4.5 mg Interval 3.5 to 7.5	2.75 mg Interval 0.9 to 4.1

SECONDARY outcome

Timeframe: During the bronchoscopy procedure only, 58.5 minutes average

Cumulative time below saturation of 90% - the total number of seconds that the pulse oximeter reported a saturation below 90%

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Placebo + Standard of Care of midazolam and fentanyl	Dexmedetomidine and Ketamine n=25 Participants dexmedetomidine and ketamine + Standard of Care (Midazolam + fentanyl)
Desaturation (Cumulative)	39 seconds Interval 8.5 to 117.5	40 seconds Interval 3.8 to 170.5

SECONDARY outcome

Timeframe: During the bronchoscopy procedure only, 58.5 minutes average

Longest time below saturation of 90% (the number of seconds elapsed between the start of a period in which the pulse oximeter saturation fell below 90% and the return above 90%)

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Placebo + Standard of Care of midazolam and fentanyl	Dexmedetomidine and Ketamine n=25 Participants dexmedetomidine and ketamine + Standard of Care (Midazolam + fentanyl)
Desaturation (Longest)	21 seconds Interval 5.0 to 43.5	18 seconds Interval 3.0 to 53.3

SECONDARY outcome

Timeframe: During the bronchoscopy procedure only, 58.5 minutes average

Patients in which the procedure could not be completed without conversion to general anesthesia

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Placebo + Standard of Care of midazolam and fentanyl	Dexmedetomidine and Ketamine n=25 Participants dexmedetomidine and ketamine + Standard of Care (Midazolam + fentanyl)
Conversion to General Anesthesia	6 Participants	1 Participants

SECONDARY outcome

Timeframe: After the bronchoscopy procedure only

Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Placebo + Standard of Care of midazolam and fentanyl	Dexmedetomidine and Ketamine n=25 Participants dexmedetomidine and ketamine + Standard of Care (Midazolam + fentanyl)
Patient Satisfaction	9 score on a scale Interval 7.0 to 10.0	10 score on a scale Interval 5.0 to 10.0

SECONDARY outcome

Timeframe: After the bronchoscopy procedure only

Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Placebo + Standard of Care of midazolam and fentanyl	Dexmedetomidine and Ketamine n=25 Participants dexmedetomidine and ketamine + Standard of Care (Midazolam + fentanyl)
Endoscopist Satisfaction	7 score on a scale Interval 5.5 to 8.5	8 score on a scale Interval 6.0 to 9.5

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexmedetomidine and Ketamine

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

Jeff E Mandel MD MS

Department of Anesthesiology & Critical Care

Phone: 2156150553

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place