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Trial record 46 of 64 for:    Recruiting, Not yet recruiting, Available Studies | "Pleural Effusion"

Respiratory Function of Dexmedetomidine in Patients Undergoing Pleuroscopy

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ClinicalTrials.gov Identifier: NCT03597828
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Tatiana Sidiropoulou, Attikon Hospital

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

Condition or disease
Pleural Effusions, Chronic Pleural Effusion, Malignant Pleural Diseases

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect on Respiratory Function of Monitored Anesthesia Care With Dexmedetomidine in Patients Undergoing Diagnostic or Therapeutic Pleuroscopy
Actual Study Start Date : August 5, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. PaO2/FIO2 ratio [ Time Frame: measured before procedure, every 30 minutes during procedure, before discharge from the postanesthesia care unit (approximately 2 hours after end of procedure) ]
    changes in lung oxygenation


Secondary Outcome Measures :
  1. FEV1 (forced expiratory volume in 1 second) [ Time Frame: before procedure and 24 hours after procedure ]
    respiratory mechanics

  2. FVC (forced vital capacity) [ Time Frame: before procedure and 24 hours after procedure ]
    respiratory mechanics

  3. FEV1/FVC ratio [ Time Frame: before procedure and 24 hours after procedure ]
    respiratory mechanics

  4. PaCO2 [ Time Frame: measured before procedure, every 30 minutes during procedure, before discharge from the postanesthesia care unit (approximately 2 hours after end of procedure) ]
    acid-base balance


Other Outcome Measures:
  1. cumulative midazolam consumption [ Time Frame: at the end of procedure ]
    measured in mg

  2. cumulative fentanyl consumption [ Time Frame: at the end of procedure ]
    measured in mg

  3. cumulative dexmedetomidine consumption [ Time Frame: at the end of procedure ]
    measured in mg

  4. Observer's Assessment of Alertness/Sedation scale (OAA/S) [ Time Frame: during procedure ]
    This 5 point Scale is used to assess level of sedation during the procedure (5- Responds readily to name spoken in normal tone, 4-Lethargic response to name spoken in normal tone, 3-Responds only after name is called loudly and/or repeatedly, 2-Responds only after mild prodding or shaking, 1-Does not respond to mild prodding or shaking)

  5. Bradycardia [ Time Frame: during the procedure ]
    incidence of bradycardia (HR <45 beats/ min) during procedure

  6. Hypotension [ Time Frame: during the procedure ]
    incidence of hypotension (MAP<65 mmHg) during procedure

  7. Hypoxemia [ Time Frame: during the procedure ]
    incidence of hypoxemia (SaO2< 92%) during procedure



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult subjects who are scheduled for a pleuroscopy procedure.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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,
  • 2nd 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03597828


Contacts
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Contact: Tatiana Sidiropoulou, MD, PhD +302105832371 tsidirop@med.uoa.gr

Locations
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Greece
Att Recruiting
Athens, Greece, 12462
Contact: Tatiana Sidiropoulou    +302105832371    tsidirop@med.uoa.gr   
Sponsors and Collaborators
Attikon Hospital

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Responsible Party: Tatiana Sidiropoulou, Assistant Professor of Anesthesiology, Attikon Hospital
ClinicalTrials.gov Identifier: NCT03597828     History of Changes
Other Study ID Numbers: DEXPLEURO
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tatiana Sidiropoulou, Attikon Hospital:
Monitored Anesthesia Care
Pleuroscopy
dexmedetomidine
fentanyl
midazolam
sedation

Additional relevant MeSH terms:
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Pleural Effusion
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Dexmedetomidine
Midazolam
Fentanyl
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General