Alternative Sedation During Bronchoscopy (DEX)

February 5, 2019 updated by: University of Pennsylvania

A Randomized, Placebo-controlled, Concealed Allocation Comparison of Respiratory Depression and Coughing During Bronchoscopy With Dexmedetomidine-ketamine as an Adjunct to Fentanyl-midazolam Sedation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand
Drug: Midazolam load
2 mg bolus prior to bronchoscopy
Other Names:
  • 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 Names:
  • 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: Midazolam demand
0.5 mg demand bolus at discretion of pulmonologist
Other Names:
  • 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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
During the bronchoscopy procedure only, 58.5 minutes average
Total Fentanyl
Time Frame: During the bronchoscopy procedure only, 58.5 minutes average
Total fentanyl dose delivered during the procedure
During the bronchoscopy procedure only, 58.5 minutes average
Total Midazolam
Time Frame: Duration of procedure
Total midazolam delivered during procedure
Duration of procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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%
During the bronchoscopy procedure only, 58.5 minutes average
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%)
During the bronchoscopy procedure only, 58.5 minutes average
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
During the bronchoscopy procedure only, 58.5 minutes average
Patient Satisfaction
Time Frame: After the bronchoscopy procedure only
Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)
After the bronchoscopy procedure only
Endoscopist Satisfaction
Time Frame: After the bronchoscopy procedure only
Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)
After the bronchoscopy procedure only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospira, now a wholly owned subsidiary of Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeff E Mandel, MD MS, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 810981

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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