Sedation
Conditions
Keywords
bronchoscopy
Brief summary
This protocol hopes to determine whether the use of dexmedetomidine-ketamine can reduce the use of standard of care fentanyl-midazolam sedation during bronchoscopy. This may result in less respiratory depression while providing better compliance with the procedure.
Detailed description
All patients enrolled in the study will be undergoing bronchoscopy, which is typically performed with sedation. All procedural sedation carries some risk. Several features of the study may lower the risk of sedation relative to that of conventional sedation. An anesthesiologist will be present throughout the procedure. Continuous monitoring of respiration with RIP will be employed. Administration of sedation will be via a volumetric syringe pump. Benefits specific to dexmedetomidine-ketamine include the lack of respiratory depression and greater hemodynamic stability.
Interventions
DRUGKetamine load
Ketamine 30 mg bolus prior to bronchoscopy
DRUGMidazolam load
2 mg bolus prior to bronchoscopy
DRUGFentanyl load
50 µg bolus prior to bronchoscopy
DRUGDexmedetomidine load
Dexmedetomidine 1 µg/kg prior to bronchoscopy
DRUGDexmedetomidine maintenance
0.5 µg/kg/hour for the duration of bronchoscopy (58.5 minutes average)
DRUGKetamine maintenance
8 µg/kg/min for the duration of bronchoscopy (58.5 minutes average)
DRUGMidazolam demand
0.5 mg demand bolus at discretion of pulmonologist
DRUGFentanyl demand
12.5 µg demand bolus at discretion of pulmonologist
DRUGBenadryl demand
25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus
Sponsors
Hospira, now a wholly owned subsidiary of Pfizer
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Adults over the age of 18 scheduled for elective flexible bronchoscopy in the endoscopy suite or OR of HUP
Exclusion criteria
* History of inability to complete bronchoscopy attributable to inadequate sedation * Requiring more than 2 LPM supplemental oxygen to maintain SaO2 \> 90% * History of allergy to study medications * Pregnancy * A history of psychosis * Any condition deemed likely by the pulmonologist or anesthesiologist to pose a significant risk due to elevation of blood pressure, including cerebral/aortic aneurysm, and or ischemic cardiovascular disease * Bradydysrhythmia deemed significant by the anesthesiologist or pulmonologist * A diagnosis of significant renal or hepatic impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decreased Minute Ventilation | 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. |
| Total Fentanyl | During the bronchoscopy procedure only, 58.5 minutes average | Total fentanyl dose delivered during the procedure |
| Total Midazolam | Duration of procedure | Total midazolam delivered during procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Desaturation (Cumulative) | 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% |
| Desaturation (Longest) | 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%) |
| Conversion to General Anesthesia | During the bronchoscopy procedure only, 58.5 minutes average | Patients in which the procedure could not be completed without conversion to general anesthesia |
| Patient Satisfaction | After the bronchoscopy procedure only | Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied) |
| Endoscopist Satisfaction | After the bronchoscopy procedure only | Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied) |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from the practices of the pulmonologist sub investigators by the principal investigator
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo + Standard of Care of midazolam and fentanyl | 25 |
| Dexmedetomidine and Ketamine dexmedetomidine and ketamine + Standard of Care of midazolam and fentanyl | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Dexmedetomidine and Ketamine | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 50 Participants |
| Age, Continuous | 61.2 years STANDARD_DEVIATION 14.9 | 59.4 years STANDARD_DEVIATION 13.2 | 59.88 years STANDARD_DEVIATION 15.86 |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 6 Participants | 13 Participants | 19 Participants |
| Sex: Female, Male Male | 19 Participants | 12 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Decreased Minute Ventilation
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.
Time frame: During the bronchoscopy procedure only, 58.5 minutes average
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Decreased Minute Ventilation | 0.736 percentage of baseline |
| Dexmedetomidine and Ketamine | Decreased Minute Ventilation | 0.764 percentage of baseline |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Primary
Total Fentanyl
Total fentanyl dose delivered during the procedure
Time frame: During the bronchoscopy procedure only, 58.5 minutes average
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Total Fentanyl | 112.5 µg |
| Dexmedetomidine and Ketamine | Total Fentanyl | 68.75 µg |
Comparison: See reference power analysisp-value: <0.01Wilcoxon (Mann-Whitney)
Primary
Total Midazolam
Total midazolam delivered during procedure
Time frame: Duration of procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Total Midazolam | 4.5 mg |
| Dexmedetomidine and Ketamine | Total Midazolam | 2.75 mg |
Comparison: See reference for power analysisp-value: 0.01Wilcoxon (Mann-Whitney)
Secondary
Conversion to General Anesthesia
Patients in which the procedure could not be completed without conversion to general anesthesia
Time frame: During the bronchoscopy procedure only, 58.5 minutes average
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Conversion to General Anesthesia | 6 Participants |
| Dexmedetomidine and Ketamine | Conversion to General Anesthesia | 1 Participants |
Secondary
Desaturation (Cumulative)
Cumulative time below saturation of 90% - the total number of seconds that the pulse oximeter reported a saturation below 90%
Time frame: During the bronchoscopy procedure only, 58.5 minutes average
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Desaturation (Cumulative) | 39 seconds |
| Dexmedetomidine and Ketamine | Desaturation (Cumulative) | 40 seconds |
Secondary
Desaturation (Longest)
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%)
Time frame: During the bronchoscopy procedure only, 58.5 minutes average
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Desaturation (Longest) | 21 seconds |
| Dexmedetomidine and Ketamine | Desaturation (Longest) | 18 seconds |
Secondary
Endoscopist Satisfaction
Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)
Time frame: After the bronchoscopy procedure only
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Endoscopist Satisfaction | 7 score on a scale |
| Dexmedetomidine and Ketamine | Endoscopist Satisfaction | 8 score on a scale |
Secondary
Patient Satisfaction
Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)
Time frame: After the bronchoscopy procedure only
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Patient Satisfaction | 9 score on a scale |
| Dexmedetomidine and Ketamine | Patient Satisfaction | 10 score on a scale |