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Alternative Sedation During Bronchoscopy

Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sedation

Intervention: dexmedetomidine and ketamine Study Medication (Drug); placebo + Standard of Care of midazolam and fentanyl (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Pennsylvania

Official(s) and/or principal investigator(s):
Jeff E Mandel, MD MS, Principal Investigator, Affiliation: University of Pennsylvania

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Minute ventilation

Time to adequate sedation and procedure duration

Secondary outcome:

Cardiopulmonary stability

Patient compliance

Fentanyl/midazolam/benadryl consumption

Frequency of rescue from inadequate sedation

Patient and endoscopist satisfaction

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
Additional Information

Starting date: June 2010
Last updated: January 14, 2013

Page last updated: August 20, 2015

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