Use of Dexmedetomidine for Sedation During Flexible Bronchoscopy in Patients With COPD: A Descriptive Study

COPD Clinical Trial

Official title:

Use of Dexmedetomidine for Sedation During Flexible Bronchoscopy in Patients With COPD: A Descriptive Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401206
• Other study ID #: RP-06078
• Status: Completed
• Phase: N/A
• First received: November 17, 2006
• Last updated: November 2, 2007
• Start date: November 2006
• Est. completion date: June 2007

Study information

• Verified date: November 2007
• Source: The Cooper Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To determine safety and effectiveness of dexmedetomidine when administered for conscious sedation during flexible bronchoscopy (FB) in patients with Chronic Obstructive pulmonary Disease (COPD).

Description:

This is a pilot study designed to provide preliminary data on the use of dexmedetomidine for outpatient FB procedures requiring sedation. Clinical parameters such as vital signs, level of sedation, dosing and supplemental sedation, and measures of comfort will be evaluated in a population of patients with known Chronic Obstructive Lung Disease undergoing elective FB.

Patients with COPD scheduled for outpatient FB will be provided with an intravenous infusion of dexmedetomidine (1 mcg/kg/hr) (Precedex®: Hospira, Inc, Lake Forest, IL) over a 15-30 min period before the procedure and continued throughout the procedure. No loading dose will be used prior to start of infusion. The FB procedure will be conducted according to standard practice using routine monitoring technique.

This dosing regimen of 1.0 mcg/kg/hr was chosen because the loading dose will be omitted and since a previous review have documented a lack of adverse events with maintenance doses exceeding 1 mcg/kg/hr.

Drug infusion will be discontinued if any of the following adverse events are observed:

recurrent apnea (Respiratory Rate <7) lasting more than 30 seconds over a 5 min observation period, sustained episodes (30 seconds) hemoglobin oxygen saturation lower than 90% over a 5 min observation period, decrease of heart rate to below 50 beats/min, mean arterial pressure below 70% of its initial value.

If needed, additional sedation will be provided with alternating doses of midazolam 1 mg, or Fentanyl 25 mcg for pain, agitation interfering with the completion of the procedure, or for persistent cough non-responsive to local lidocaine instillation. The amount of Fentanyl and versed used as an adjunct for conscious sedation will also be recorded as part of this study.

The quality of sedation will be assessed using the Richmond Agitation Sedation Scale. The quality of analgesia will be assessed using the 11-point (0-10) Numerical Pain Rating scale (NRS). The level of recovery from anesthesia and the return of psychomotor fitness will be assessed using the Modified Post anesthesia Discharge Scoring System (MPADSS). The duration of FB and the time from the end of the procedure to the patient reaching a score of 9 and 10 on the MPADSS (readiness for discharge) will also be measured.

Except for the measurements described above (NRS), no additional procedures will be performed for the purposes of this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject has COPD

• Subject is = 18 years of age

• If female, subject is non-lactating and either not able to become pregnant or proven not to be pregnant and actively practicing birth control

• Subject or subject's legally authorized representative has voluntarily signed and dated an informed consent after all has been explained and any/all questions answered

Exclusion Criteria:

• Subject for whom a2 agonists are contraindicated

• Subject for whom opiates, benzodiazepines, or dexmedetomidine are contraindicated or who has known or suspected serious allergy to any drug that might be administered during the course of the study

Subject meets any of the following cardiovascular criteria:

(A routine EKG will be performed for potential subjects prior to enrollment in order to screen for unrecognized conduction abnormalities.)

• Acute unstable angina (defined during current hospital stay)

• Myocardial infarction within 6 weeks of bronchoscopy

• Suspicion of acute myocardial infarction

• Known severe left ventricular failure

• Heart rate < 50 bpm prior to infusion start

• Systolic blood pressure less than 90 mmHg prior to infusion start

• Conduction abnormalities except 1st degree AV block and rate-controlled atrial fibrillation; subjects with functional pacemaker capacity can be enrolled

• Known severe liver disease

• Subject requires dialysis (e.g., hemodialysis, peritoneal dialysis, CVVHD)

• Subject has a known, uncontrolled seizure disorder

• Subject on a-agonists or blockers

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Flexible Bronchoscopy
• Sedation

Intervention

Drug:
• dexmedetomidine

Locations

Country	Name	City	State
United States	Cooper University Hospital	Camden	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
The Cooper Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and efficacy
Primary	Level of sedation
Primary	Pain rating
Secondary	Drug dosing
Secondary	Supplemental sedation