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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
Results First Posted : October 31, 2018
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
University of Pennsylvania

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 load Drug: Ketamine load Drug: Midazolam load Drug: Fentanyl load Drug: Dexmedetomidine maintenance Drug: Ketamine maintenance Drug: Midazolam demand Drug: Fentanyl demand Drug: Benadryl demand 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.

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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
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand
Drug: Midazolam load
2 mg bolus prior to bronchoscopy
Other Name: Versed

Drug: Fentanyl load
50 µg bolus prior to bronchoscopy
Other Names:
  • Abstral
  • Actiq
  • Fentora
  • Onsolis

Drug: Midazolam demand
0.5 mg demand bolus at discretion of pulmonologist
Other Name: Versed

Drug: Fentanyl demand
12.5 µg demand bolus at discretion of pulmonologist
Other Names:
  • Abstral
  • Actiq
  • Fentora
  • Onsolis

Drug: Benadryl demand
25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus
Other Names:
  • Diphenhydramine Hcl
  • Aler-Dryl
  • Banophen
  • Ben Tann
  • Bromanate AF
  • Diphen
  • Diphenadryl
  • Diphenhist
  • Dytan
  • Unisom
  • Sominex
  • Silphen
  • Siladryl

Active Comparator: dexmedetomidine and ketamine
dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
Drug: Dexmedetomidine load
Dexmedetomidine 1 µg/kg prior to bronchoscopy
Other Names:
  • Precedex
  • Dexmedetomidine Hydrochloride

Drug: Ketamine load
Ketamine 30 mg bolus prior to bronchoscopy
Other Names:
  • Ketalar
  • Calypsol
  • Ketamin
  • Ketaminol
  • Ketanest
  • Tekam
  • Vetalar

Drug: Dexmedetomidine maintenance
0.5 µg/kg/hour for the duration of bronchoscopy (58.5 minutes average)
Other Names:
  • Precedex
  • Dexmedetomidine Hydrochloride

Drug: Ketamine maintenance
8 µg/kg/min for the duration of bronchoscopy (58.5 minutes average)
Other Names:
  • Ketalar
  • Calypsol
  • Ketamin
  • Ketaminol
  • Ketanest
  • Tekam
  • Vetalar

Drug: Midazolam demand
0.5 mg demand bolus at discretion of pulmonologist
Other Name: Versed

Drug: Fentanyl demand
12.5 µg demand bolus at discretion of pulmonologist
Other Names:
  • Abstral
  • Actiq
  • Fentora
  • Onsolis

Drug: Benadryl demand
25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus
Other Names:
  • Diphenhydramine Hcl
  • Aler-Dryl
  • Banophen
  • Ben Tann
  • Bromanate AF
  • Diphen
  • Diphenadryl
  • Diphenhist
  • Dytan
  • Unisom
  • Sominex
  • Silphen
  • Siladryl




Primary Outcome Measures :
  1. Decreased Minute Ventilation [ Time Frame: During the bronchoscopy procedure only, 58.5 minutes average ]
    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.

  2. Total Fentanyl [ Time Frame: During the bronchoscopy procedure only, 58.5 minutes average ]
    Total fentanyl dose delivered during the procedure

  3. Total Midazolam [ Time Frame: Duration of procedure ]
    Total midazolam delivered during procedure


Secondary Outcome Measures :
  1. Desaturation (Cumulative) [ Time Frame: During the bronchoscopy procedure only, 58.5 minutes average ]
    Cumulative time below saturation of 90% - the total number of seconds that the pulse oximeter reported a saturation below 90%

  2. Desaturation (Longest) [ Time Frame: During the bronchoscopy procedure only, 58.5 minutes average ]
    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%)

  3. Conversion to General Anesthesia [ Time Frame: During the bronchoscopy procedure only, 58.5 minutes average ]
    Patients in which the procedure could not be completed without conversion to general anesthesia

  4. Patient Satisfaction [ Time Frame: After the bronchoscopy procedure only ]
    Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)

  5. Endoscopist Satisfaction [ Time Frame: After the bronchoscopy procedure only ]
    Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
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

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
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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
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Principal Investigator: Jeff E Mandel, MD MS University of Pennsylvania

Publications of Results:
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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
Results First Posted: October 31, 2018
Last Update Posted: February 26, 2019
Last Verified: February 2019
Keywords provided by University of Pennsylvania:
bronchoscopy
Additional relevant MeSH terms:
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Diphenhydramine
Promethazine
Fentanyl
Midazolam
Dexmedetomidine
Ketamine
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