Alternative Sedation During Bronchoscopy

NCT01158820 | Completed Phase 4 Results DMC

• 1 other identifier: 810981
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation

Keywords

bronchoscopy

Outcome Measures

Primary Outcomes (3)

• Decreased Minute Ventilation

  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

  Total fentanyl dose delivered during the procedure

  During the bronchoscopy procedure only, 58.5 minutes average

• Total Midazolam

  Total midazolam delivered during procedure

  Duration of procedure

Secondary Outcomes (5)

• Desaturation (Cumulative)

  During the bronchoscopy procedure only, 58.5 minutes average

• Desaturation (Longest)

  During the bronchoscopy procedure only, 58.5 minutes average

• Conversion to General Anesthesia

  During the bronchoscopy procedure only, 58.5 minutes average

• Patient Satisfaction

  After the bronchoscopy procedure only

• Endoscopist Satisfaction

  After the bronchoscopy procedure only

Study Arms (2)

Placebo

PLACEBO COMPARATOR

midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand

Drug: Midazolam load; Drug: Fentanyl load; Drug: Midazolam demand; Drug: Fentanyl demand; Drug: Benadryl demand

dexmedetomidine and ketamine

ACTIVE COMPARATOR

dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand

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

Interventions

Dexmedetomidine load DRUG

Dexmedetomidine 1 µg/kg prior to bronchoscopy

Also known as: Precedex, Dexmedetomidine Hydrochloride

dexmedetomidine and ketamine

Ketamine load DRUG

Ketamine 30 mg bolus prior to bronchoscopy

Also known as: Ketalar, Calypsol, Ketamin, Ketaminol, Ketanest, Tekam, Vetalar

dexmedetomidine and ketamine

Midazolam load DRUG

2 mg bolus prior to bronchoscopy

Also known as: Versed

Placebo

Fentanyl load DRUG

50 µg bolus prior to bronchoscopy

Also known as: Abstral, Actiq, Fentora, Onsolis

Placebo

Dexmedetomidine maintenance DRUG

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

Also known as: Precedex, Dexmedetomidine Hydrochloride

dexmedetomidine and ketamine

Ketamine maintenance DRUG

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

Also known as: Ketalar, Calypsol, Ketamin, Ketaminol, Ketanest, Tekam, Vetalar

dexmedetomidine and ketamine

Midazolam demand DRUG

0.5 mg demand bolus at discretion of pulmonologist

Also known as: Versed

Placebo; dexmedetomidine and ketamine

Fentanyl demand DRUG

12.5 µg demand bolus at discretion of pulmonologist

Also known as: Abstral, Actiq, Fentora, Onsolis

Placebo; dexmedetomidine and ketamine

Benadryl demand DRUG

25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus

Also known as: Diphenhydramine Hcl, Aler-Dryl, Banophen, Ben Tann, Bromanate AF, Diphen, Diphenadryl, Diphenhist, Dytan, Unisom, Sominex, Silphen, Siladryl

Placebo; dexmedetomidine and ketamine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over the age of 18 scheduled for elective flexible bronchoscopy in the endoscopy suite or OR of HUP

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Hospira, now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Yarmus LB, Akulian JA, Gilbert C, Mathai SC, Sathiyamoorthy S, Sahetya S, Harris K, Gillespie C, Haas A, Feller-Kopman D, Sterman D, Lee HJ. Comparison of moderate versus deep sedation for endobronchial ultrasound transbronchial needle aspiration. Ann Am Thorac Soc. 2013 Apr;10(2):121-6. doi: 10.1513/AnnalsATS.201209-074OC.

  PMID: 23607840 RESULT

MeSH Terms

Interventions

Dexmedetomidine; Ketamine; Midazolam; Fentanyl; Diphenhydramine; Doxylamine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperidines; Ethylamines; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Pyridines

Limitations and Caveats

The presence of an anesthesiologist may have affected the aggressiveness of the pulmonologists in administering sedation. Alterations in the study drug were not permitted; an open label study might find larger differences in respiratory measures

Results Point of Contact

• Title: Jeff E Mandel MD MS
• Organization: Department of Anesthesiology & Critical Care

mandelj@uphs.upenn.edu

2156150553

Study Officials

• Jeff E Mandel, MD MS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: July 8, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: February 26, 2019
• Results First Posted: October 31, 2018

Record last verified: 2019-02

Locations

US (1)