Alternative Sedation During Bronchoscopy

Sedation Clinical Trial

— DEX  

Official title:

A Randomized, Placebo-controlled, Concealed Allocation Comparison of Respiratory Depression and Coughing During Bronchoscopy With Dexmedetomidine-ketamine as an Adjunct to Fentanyl-midazolam Sedation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01158820
• Other study ID #: 810981
• Status: Completed
• Phase: Phase 4
• Start date: June 2010
• Est. completion date: May 2012

Study information

• Verified date: February 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Sedation

Intervention

Drug:
• Dexmedetomidine load
Dexmedetomidine 1 µg/kg prior to bronchoscopy
• Ketamine load
Ketamine 30 mg bolus prior to bronchoscopy
• Midazolam load
2 mg bolus prior to bronchoscopy
• Fentanyl load
50 µg bolus prior to bronchoscopy
• Dexmedetomidine maintenance
0.5 µg/kg/hour for the duration of bronchoscopy (58.5 minutes average)
• Ketamine maintenance
8 µg/kg/min for the duration of bronchoscopy (58.5 minutes average)
• Midazolam demand
0.5 mg demand bolus at discretion of pulmonologist
• Fentanyl demand
12.5 µg demand bolus at discretion of pulmonologist
• Benadryl demand
25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Hospira, now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (1)

Yarmus LB, Akulian JA, Gilbert C, Mathai SC, Sathiyamoorthy S, Sahetya S, Harris K, Gillespie C, Haas A, Feller-Kopman D, Sterman D, Lee HJ. Comparison of moderate versus deep sedation for endobronchial ultrasound transbronchial needle aspiration. Ann Am — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	During the bronchoscopy procedure only, 58.5 minutes average
Primary	Total Fentanyl	Total fentanyl dose delivered during the procedure	During the bronchoscopy procedure only, 58.5 minutes average
Primary	Total Midazolam	Total midazolam delivered during procedure	Duration of procedure
Secondary	Desaturation (Cumulative)	Cumulative time below saturation of 90% - the total number of seconds that the pulse oximeter reported a saturation below 90%	During the bronchoscopy procedure only, 58.5 minutes average
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%)	During the bronchoscopy procedure only, 58.5 minutes average
Secondary	Conversion to General Anesthesia	Patients in which the procedure could not be completed without conversion to general anesthesia	During the bronchoscopy procedure only, 58.5 minutes average
Secondary	Patient Satisfaction	Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)	After the bronchoscopy procedure only
Secondary	Endoscopist Satisfaction	Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)	After the bronchoscopy procedure only