Alternative Sedation During Bronchoscopy

University of Pennsylvania50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Sedation

Interventions

Dexmedetomidine loadDRUG

Dexmedetomidine 1 µg/kg prior to bronchoscopy

Ketamine loadDRUG

Ketamine 30 mg bolus prior to bronchoscopy

Midazolam loadDRUG

2 mg bolus prior to bronchoscopy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Total Fentanyl

Total fentanyl dose delivered during the procedure

Time frame: During the bronchoscopy procedure only, 58.5 minutes average

Total Midazolam

Total midazolam delivered during procedure

Time frame: Duration of procedure

Secondary Outcomes

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

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

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

Patient Satisfaction

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.