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Alternative Sedation During Bronchoscopy (DEX)

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ClinicalTrials.gov Identifier: NCT01158820
Recruitment Status : Completed
First Posted : July 8, 2010
Last Update Posted : November 30, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : June 2010
Primary Completion Date : May 2012
Study Completion Date : May 2012


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Minute ventilation [ Time Frame: About 2-3 hours during the bronchoscopy procedure only ]
    This will be assessed by calibrated respiratory inductance plethysmography

  2. Time to adequate sedation and procedure duration [ Time Frame: About 2-3 hours during the bronchoscopy procedure only ]
    Amount of time and duration of adequate sedation of the patient


Secondary Outcome Measures :
  1. Cardiopulmonary stability [ Time Frame: About 2-3 hours during the bronchoscopy procedure only ]
    assessed by heart rate and pulse oximetry

  2. Patient compliance [ Time Frame: About 2-3 hours during the bronchoscopy procedure only ]
    assessed by the number of coughs per minute during the procedure

  3. Fentanyl/midazolam/benadryl consumption [ Time Frame: About 2-3 hours during the bronchoscopy procedure only ]
    The measurement of the amount of the standard of care sedation medications will be used during the procedure.

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

  5. Patient and endoscopist satisfaction [ Time Frame: About 2-3 hours during the bronchoscopy procedure only ]
    assessed by Likert scale


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01158820


Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Hospira, now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Jeff E Mandel, MD MS University of Pennsylvania
More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01158820     History of Changes
Other Study ID Numbers: 810981
First Posted: July 8, 2010    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017

Keywords provided by University of Pennsylvania:
bronchoscopy

Additional relevant MeSH terms:
Dexmedetomidine
Midazolam
Diphenhydramine
Ketamine
Fentanyl
Promethazine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents