Alternative Sedation During Bronchoscopy (DEX)

University of Pennsylvania

Status and phase: Completed; Phase 4

Conditions: Sedation

Treatments: Drug: Ketamine load; Drug: Midazolam demand; Drug: Fentanyl demand; Drug: Benadryl demand; Drug: Midazolam load; Drug: Dexmedetomidine load; Drug: Fentanyl load; Drug: Ketamine maintenance; Drug: Dexmedetomidine maintenance

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01158820

810981

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand

Treatment:

Drug: Fentanyl load

Drug: Midazolam load

Drug: Benadryl demand

Drug: Fentanyl demand

Drug: Midazolam demand

dexmedetomidine and ketamine

Active Comparator group

Description:

dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand

Treatment:

Drug: Dexmedetomidine maintenance

Drug: Ketamine maintenance

Drug: Dexmedetomidine load

Drug: Benadryl demand

Drug: Fentanyl demand

Drug: Midazolam demand

Drug: Ketamine load