Respiratory Function of Dexmedetomidine in Patients Undergoing Pleuroscopy

NCT03597828 | Completed

• 1 other identifier: DEXPLEURO
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this prospective trial will be to assess the effects of dexmedetomidine administration on oxygenation and respiratory function in patients undergoing diagnostic or therapeutic medical thoracoscopy/pleuroscopy for a pleural effusion compared to conventional conscious sedation/monitored anesthesia care (MAC) with midazolam. The secondary endpoint of the study will be to also assess the effects of dexmedetomidine administration on respiratory mechanics and postprocedural complications

Conditions

Pleural Effusions, Chronic; Pleural Effusion, Malignant; Pleural Diseases

Keywords

Monitored Anesthesia Care; Pleuroscopy; dexmedetomidine; fentanyl; midazolam; sedation

Outcome Measures

Primary Outcomes (1)

• PaO2/FIO2 ratio

  changes in lung oxygenation

  measured before procedure, every 30 minutes during procedure, before discharge from the postanesthesia care unit (approximately 2 hours after end of procedure)

Secondary Outcomes (4)

• FEV1 (forced expiratory volume in 1 second)

  before procedure and 24 hours after procedure

• FVC (forced vital capacity)

  before procedure and 24 hours after procedure

• FEV1/FVC ratio

  before procedure and 24 hours after procedure

• PaCO2

  measured before procedure, every 30 minutes during procedure, before discharge from the postanesthesia care unit (approximately 2 hours after end of procedure)

Other Outcomes (7)

• cumulative midazolam consumption

  at the end of procedure

• cumulative fentanyl consumption

  at the end of procedure

• cumulative dexmedetomidine consumption

  at the end of procedure

Study Arms (2)

DEXMEDETOMIDINE

Dexmedetomidine infusion for pleuroscopy sedation. Rescue drugs will be midazolam for inadequate sedation and fentanyl for pain control

MIDAZOLAM/FENTANYL

Midazolam for sedation and fentanyl for pain will be used for pleuroscopy monitored anesthesia care

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult subjects who are scheduled for a pleuroscopy procedure.

You may qualify if:

• Age ≥ 18 years old
• American Society of Anesthesiologists (ASA) physical status of I-IV
• scheduled to undergo medical thoracoscopy/pleuroscopy.

You may not qualify if:

• general anesthesia within 7 days prior to study entry
• received an α2-agonist or antagonist within 14 days before the procedure
• received an intravenous opioid within 1 hour
• received an oral or intramuscular opioid within 4 hours from procedure
• New York Heart Association class ≥3
• acute unstable angina
• acute myocardial infarction (confirmed by laboratory findings) in the past 6 weeks
• heart rate (HR) ≤45-50 bpm
• systolic blood pressure (SBP) ≤90 mm Hg,
• nd or/and 3rd-degree Atrioventricular (AV) block (if the patient does not have a pacemaker)
• severe functional liver or kidney disease,
• obesity (body mass index ≥30 kg/m-2)
• severe restrictive interstitial lung disease

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

Att

Athens, 12462, Greece

Location

MeSH Terms

Conditions

Pleural Effusion; Bronchiolitis Obliterans Syndrome; Pleural Effusion, Malignant; Pleural Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 24, 2018
• Study Start: August 5, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: June 30, 2020

Record last verified: 2020-06

Locations

GR (1)