The Effect on Respiratory Function of Monitored Anesthesia Care With Dexmedetomidine in Patients Undergoing Diagnostic or Therapeutic Pleuroscopy
Sponsor study identifier
observational
60
1 country
1
Study Start
August 5, 2018
Actual (reported)Primary Completion
June 30, 2020
Actual (reported)Study Completion
June 30, 2020
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 27, 2018
Actual (reported)July 24, 2018
Actual (reported)August 5, 2018
Actual (reported)June 30, 2020
Actual (reported)June 30, 2020
Actual (reported)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)
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
Dexmedetomidine infusion for pleuroscopy sedation. Rescue drugs will be midazolam for inadequate sedation and fentanyl for pain control
Midazolam for sedation and fentanyl for pain will be used for pleuroscopy monitored anesthesia care
Adult subjects who are scheduled for a pleuroscopy procedure.
Att
Athens, 12462, Greece
60 participants (actual enrollment reported by the registry).
First Submitted
June 27, 2018
First Posted
July 24, 2018
Study Start
August 5, 2018
Actual (reported)Management of Malignant Pleural Effusion With Indwelling Pleural Catheter Versus Silver Nitrate Pleurodesis
Malignant Pleural Effusion: Pleur-X vs. Chemical Pleurodesis in VATS
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)
cumulative midazolam consumption
at the end of procedure
cumulative fentanyl consumption
at the end of procedure
cumulative dexmedetomidine consumption
at the end of procedure
Contact the study team to confirm eligibility.
Primary Completion
June 30, 2020
Actual (reported)Study Completion
June 30, 2020
Actual (reported)Last Updated
June 30, 2020
Record last verified: 2020-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: