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Trial · NCT07532733

Respiratory and Haemodynamic Effects of Conscious Sedation With Dexmedetomidine for a TAVI Procedure

NCT07532733, Not applicable, Recruiting, Erasme University Hospital

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Respiratory and Haemodynamic Effects of Conscious Sedation With Dexmedetomidine for a TAVI Procedure. Trials, record NCT07532733. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07532733

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Respiratory and Haemodynamic Effects of Conscious Sedation With Dexmedetomidine for a TAVI Procedure
NCT number
NCT07532733
Status
Recruiting
Phases
Not applicable
Enrollment
80 participants, estimated
Lead sponsor
Erasme University Hospital
Conditions
TAVI(Transcatheter Aortic Valve Implantation)
Interventions
Sedation with dexmedetomidine, sedation propofol and remifentanil
First posted
2026-04-16
Last updated
2026-04-30

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Primarythe occurrence of an intraoperative respiratory event during a TAVI procedure performed under sedationduring sedation for TAVI procedure
Oxygen desaturation, defined as: * moderate desaturation with an SpO₂ ≤ 95%, * severe/significant desaturation with an SpO₂ ≤ 90%, Bradypnoea, defined as a respiratory rate \< 10 breaths per minute, Impaired ventilation as evidenced by capnography, measured using the CapnoLine® device, including: * a reduction in waveform amplitude, * respiratory irregularity, * or any abnormality consistent with hypoventilation or airway obstruction. Respiratory monitoring will be carried out continuously throughout the procedure, including monitoring of oxygen saturation, respiratory rate and capnography
SecondaryPostoperative cognitive functionthe day before TAVI procedure and between 24 and 48 hours postoperatively.
Changes in the MoCA (Montreal Cognitive Assessment) score between the preoperative period (performed the day before de TAVI procedure) and the postoperative period (performed between 24 and 48 hours after TAVI procedure). The MoCA is a rapid cognitive screening test, scored out of 30, used to identify mild or more severe cognitive impairment. A score of 30/30 indicates the absence of cognitive impairment. The lower the score, the more severe the cognitive impairment. Here, we will examine the difference between the pre- and post-measurements, which will be calculated statistically using the score.
SecondaryIntraoperative blood pressure stabilityduring sedation and TAVI procedureVariations blood pressure during the procedure. Blood pressure will be measured in mm Hg using an arterial catheter. Need for vasopressors or corrective interventions.
SecondaryHeart Rate stability during procedureduring sedation and TAVI procedureVariations in haert rate (beat per minute) during the procedure. Need for corrective interventions.
SecondaryComfort and quality of sedationDay 0 (at the completion of the TAVI procedure)
Assessment of patient comfort, of the anaesthetist and the operating cardiologist using Visual Analog Scale (ranging from 0 to 10). A score of 0 indicates complete dissatisfaction, whilst a score of 10 indicates maximum satisfaction
SecondaryLength of hospital stayup to 30 daysHospital length of stay (in days) defined as the time from completion of the TAVI procedure until hospital discharge
SecondaryTolerance and safetyup to 30 daysOccurrence of intra- and post-operative adverse events related to sedation, from the start of the sedation for TAVI procedure until the hospital discharge

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07532733

GET https://conductscience.org/api/trials/v1/NCT07532733/registered