NCT06729086

Brief Summary

The hypothesis of our study: presence of a relationship between the type of anesthesia and complications after cardiac surgery. The aim is to assess the benefit of using intravenous or inhaled anesthesia on the patients\' stay and its complications.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 11, 2024

Completed
24 days until next milestone

Study Start

First participant enrolled

January 4, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

September 27, 2024

Last Update Submit

December 9, 2024

Conditions

Keywords

propofol vs sevoflurane in cardiac surgeryperoperativepostoperativerandomized clinical trialcomplications

Outcome Measures

Primary Outcomes (1)

  • determine the relationship between myocardial protection and type of anesthesia

    troponin T dosage

    48 hours after the surgery

Secondary Outcomes (5)

  • Association between the type of anesthesia and the speed of awakening

    48 hours after the surgery

  • Association between the length of stay in intensive care and the type of anesthesia

    72 hours after the surgery

  • Determine a relationship between the type of anesthesia and the hemodynamic profile

    48 hours after the surgery

  • Association between the type of anesthesia and pulmonary complications

    72 hours after the surgery

  • Association between the type of anesthesia and neurological complications

    72 hours after the surgery

Study Arms (2)

sedation using propofol

PLACEBO COMPARATOR

this group will include all patients who will receive propofol during the cardiac surgery and afterwards in the intensive care unit during the post operative phase

Drug: sedation using propofol

sedation using sevoflurane

ACTIVE COMPARATOR

this group will include all patients who will receive sevoflurance druing the cardiac surgery and afterwards in the intensive care unit during the postoperative phase

Drug: sedation using sevoflurane

Interventions

The different complications studied will be for example respiratory, neurologic and cardiac based on several clinical and biological parameters.

sedation using propofol

The differents complications studied will be for example respiratory, neurologic and cardiac based on severl clinical and biological parameters.

sedation using sevoflurane

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all patients above 18 yeras old that will undergo a cardiac surgery

You may not qualify if:

  • below 18 yeras old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2024

First Posted

December 11, 2024

Study Start

January 4, 2025

Primary Completion

March 31, 2025

Study Completion

May 31, 2025

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share