Alternative Sedation During Bronchoscopy (DEX)
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| ClinicalTrials.gov Identifier: NCT01158820 |
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Recruitment Status :
Completed
First Posted : July 8, 2010
Results First Posted : October 31, 2018
Last Update Posted : February 26, 2019
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Sponsor:
University of Pennsylvania
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
University of Pennsylvania
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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 |
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 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
MedlinePlus Genetics related topics:
Depression
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand
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Drug: Midazolam load
2 mg bolus prior to bronchoscopy
Other Name: Versed Drug: Fentanyl load 50 µg bolus prior to bronchoscopy
Other Names:
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:
Drug: Benadryl demand 25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus
Other Names:
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Active Comparator: dexmedetomidine and ketamine
dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
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Drug: Dexmedetomidine load
Dexmedetomidine 1 µg/kg prior to bronchoscopy
Other Names:
Drug: Ketamine load Ketamine 30 mg bolus prior to bronchoscopy
Other Names:
Drug: Dexmedetomidine maintenance 0.5 µg/kg/hour for the duration of bronchoscopy (58.5 minutes average)
Other Names:
Drug: Ketamine maintenance 8 µg/kg/min for the duration of bronchoscopy (58.5 minutes average)
Other Names:
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:
Drug: Benadryl demand 25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus
Other Names:
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Primary Outcome Measures :
- 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.
- Total Fentanyl [ Time Frame: During the bronchoscopy procedure only, 58.5 minutes average ]Total fentanyl dose delivered during the procedure
- Total Midazolam [ Time Frame: Duration of procedure ]Total midazolam delivered during procedure
Secondary Outcome Measures :
- 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%
- 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%)
- 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
- Patient Satisfaction [ Time Frame: After the bronchoscopy procedure only ]Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)
- Endoscopist Satisfaction [ Time Frame: After the bronchoscopy procedure only ]Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)
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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
| 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 |
Publications of Results:
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01158820 |
| 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:
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bronchoscopy |
Additional relevant MeSH terms:
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Diphenhydramine 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 Psychotropic Drugs |