- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06012955
Study on the Effect of Target-controlled Infusion for General Anesthesia in Cardiac Surgery
August 25, 2023 updated by: Wuhan Union Hospital, China
Study on the Effect of Target-controlled Infusion of Propofol and Remifentanil for Patients Undergoing Cardiac Surgery
The purpose of the study was to evaluate whether individualized general anesthesia with target-controlled infusion could help patients wake up early for extubation and reduce the incidence of postoperative complications, and to investigate the effectiveness and safety of its application in patients undergoing cardiac surgery.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Qingping Wu
- Phone Number: 13971605283
- Email: wqp1968@163.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430022
- Recruiting
- Wuhan Union Hospital
-
Contact:
- Qingping Wu
- Phone Number: 13971605283
- Email: wqp1968@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients aged 18 years or olderundergoing cardiac surgery under general anesthesia
Description
Inclusion Criteria:
- All patients aged 18 years and older who underwent cardiac surgery
Exclusion Criteria:
- Mechanical ventilation support before surgery;
- Combined with any type of non-cardiac surgeries;
- Second exploratory thoracotomy after surgery;
- Died or discharged within 48 h after surgery;
- Missing clinical data
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
TCI group
patients receiving general anesthesia using target-controlled infusion delivery system
|
Target-controlled infusion (TCI) with propofol and remifentanil was used for anesthesia induction and maintenance
|
|
MCI group
patients receiving general anesthesia using conventional manual controlled infusion delivery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of postoperative mechanical ventilation
Time Frame: 4 weeks after surgery
|
Duration of mechanical ventilation was defined as the time from the end of surgery to tracheal extubation
|
4 weeks after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 30, 2023
Primary Completion (Estimated)
December 31, 2023
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
August 20, 2023
First Submitted That Met QC Criteria
August 25, 2023
First Posted (Actual)
August 28, 2023
Study Record Updates
Last Update Posted (Actual)
August 28, 2023
Last Update Submitted That Met QC Criteria
August 25, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- TCI202112
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.