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Completed

NCT Number: NCT01158820

Alternative Sedation During Bronchoscopy

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.

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Key information

Conditions

Sedation

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine load

Drug

Dexmedetomidine 1 µg/kg prior to bronchoscopy

Other names: Precedex, Dexmedetomidine Hydrochloride

Ketamine load

Drug

Ketamine 30 mg bolus prior to bronchoscopy

Other names: Ketalar, Calypsol, Ketamin, Ketaminol, Ketanest, Tekam, Vetalar

Midazolam load

Drug

2 mg bolus prior to bronchoscopy

Other names: Versed

Fentanyl load

Drug

50 µg bolus prior to bronchoscopy

Other names: Abstral, Actiq, Fentora, Onsolis

Dexmedetomidine maintenance

Drug

0.5 µg/kg/hour for the duration of bronchoscopy (58.5 minutes average)

Other names: Precedex, Dexmedetomidine Hydrochloride

Ketamine maintenance

Drug

8 µg/kg/min for the duration of bronchoscopy (58.5 minutes average)

Other names: Ketalar, Calypsol, Ketamin, Ketaminol, Ketanest, Tekam, Vetalar

Midazolam demand

Drug

0.5 mg demand bolus at discretion of pulmonologist

Other names: Versed

Fentanyl demand

Drug

12.5 µg demand bolus at discretion of pulmonologist

Other names: Abstral, Actiq, Fentora, Onsolis

Benadryl demand

Drug

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

Registry information

Official study 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

Acronym: DEX

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 8, 2010
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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