Alternative Sedation During Bronchoscopy (DEX)

This study has been completed.
Sponsor:
Collaborator:
Hospira, Inc.
Information provided by (Responsible Party):
Jeff E. Mandel, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01158820
First received: June 25, 2010
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Sedation
Drug: dexmedetomidine and ketamine Study Medication
Drug: placebo + Standard of Care of midazolam and fentanyl
Phase 4

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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Minute ventilation [ Time Frame: About 2-3 hours during the bronchoscopy procedure only ] [ Designated as safety issue: Yes ]
    This will be assessed by calibrated respiratory inductance plethysmography

  • Time to adequate sedation and procedure duration [ Time Frame: About 2-3 hours during the bronchoscopy procedure only ] [ Designated as safety issue: No ]
    Amount of time and duration of adequate sedation of the patient


Secondary Outcome Measures:
  • Cardiopulmonary stability [ Time Frame: About 2-3 hours during the bronchoscopy procedure only ] [ Designated as safety issue: Yes ]
    assessed by heart rate and pulse oximetry

  • Patient compliance [ Time Frame: About 2-3 hours during the bronchoscopy procedure only ] [ Designated as safety issue: Yes ]
    assessed by the number of coughs per minute during the procedure

  • Fentanyl/midazolam/benadryl consumption [ Time Frame: About 2-3 hours during the bronchoscopy procedure only ] [ Designated as safety issue: No ]
    The measurement of the amount of the standard of care sedation medications will be used during the procedure.

  • Frequency of rescue from inadequate sedation [ Time Frame: About 2-3 hours during the bronchoscopy procedure only ] [ Designated as safety issue: Yes ]
    Measurement of time frame of inadequate sedation requiring intervention from the anesthesiologist.

  • Patient and endoscopist satisfaction [ Time Frame: About 2-3 hours during the bronchoscopy procedure only ] [ Designated as safety issue: Yes ]
    assessed by Likert scale


Enrollment: 50
Study Start Date: June 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo + Standard of Care of midazolam and fentanyl
  1. Nebulized lidocaine 2% (maximum dose 200 mg) will be administered for 20 minutes.
  2. Following nebulization, syringe A (placebo) will be given at a rate of 1 µg/kg (based on a concentration of 4 µg/ml) for 10 minutes. Supplemental topical anesthesia will be administered by the pulmonologist during this time.
  3. After step 2, syringe B (midazolam 2 mg and fentanyl 50 µg) will be administered by the anesthesiologist. The infusion rate of syringe A (placebo) will be decreased to 0.7 µg/kg/hr. Syringe C (placebo) will be infused at 4 µg/kg/min (based on 10 mg/ml concentration)
  4. Boluses of 0.5 mg midazolam and 12.5 µg fentanyl will be administered by the pulmonologist from syringe D as needed for patient comfort. Syringe E (benadryl 25 mg) will be administered in entirety by the anesthesiologist after the 6th and 16th bolus of midazolam/fentanyl.
Drug: placebo + Standard of Care of midazolam and fentanyl
Control Saline 50 ml Midazolam 2 mg + Fentanyl 50 µg Saline 20 ml Midazolam 10 mg + Fentanyl 250 µg + saline 5 ml Benadryl 25 mg
Active Comparator: dexmedetomidine and ketamine + Standard of Care
  1. Nebulized lidocaine 2% (maximum dose 200 mg) will be administered for 20 minutes.
  2. Following nebulization, syringe A (dexmedetomidine) will be given at a rate of 1 µg/kg (based on a concentration of 4 µg/ml) for 10 minutes. Supplemental topical anesthesia will be administered by the pulmonologist during this time.
  3. After step 2, syringe B (ketamine 30 mg) will be administered by the anesthesiologist. The infusion rate of syringe A (dexmedetomidine) will be decreased to 0.7 µg/kg/hr. Syringe C (ketamine) will be infused at 4 µg/kg/min (based on 10 mg/ml concentration)
  4. Boluses of 0.5 mg midazolam and 12.5 µg fentanyl will be administered by the pulmonologist from syringe D as needed for patient comfort. Syringe E (benadryl 25 mg) will be administered in entirety by the anesthesiologist after the 6th and 16th bolus of midazolam/fentanyl.
Drug: dexmedetomidine and ketamine Study Medication
Experimental Dexmedetomidine 200 µg in 50 ml Ketamine 30 mg Ketamine 200 mg in 20 ml Midazolam 10 mg + Fentanyl 250 µg + saline 5 ml Benadryl 25 mg

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01158820

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Hospira, Inc.
Investigators
Principal Investigator: Jeff E Mandel, MD MS University of Pennsylvania
  More Information

No publications provided

Responsible Party: Jeff E. Mandel, Assistant Professor of Anesthesiology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01158820     History of Changes
Other Study ID Numbers: 810981
Study First Received: June 25, 2010
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
bronchoscopy

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Ketamine
Fentanyl
Dexmedetomidine
Midazolam
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents

ClinicalTrials.gov processed this record on September 11, 2014