- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07288099
Target-Controlled Infusion (TCI) vs Inhalational Anesthesia in Video-Assisted Thoracoscopic Surgery (VATS) (TCI-INHALE)
Prospective Observational Cohort Study Comparing Recovery Profiles After Target-Controlled Infusion Versus Inhalational Anesthesia in Video-Assisted Thoracoscopic Surgery
This study is designed as a prospective observational cohort to evaluate recovery after video-assisted thoracoscopic surgery (VATS). In our clinic, anesthesia for VATS is commonly provided either with target-controlled infusion (TCI) or with inhalational agents, depending on the routine practice of the anesthesiologist. No randomization or additional intervention will be performed.
During the study period, patients who receive either method as part of standard care will be followed, and perioperative and postoperative data will be recorded. Awakening time, extubation time, Aldrete score progression, pain levels, and early postoperative complications will be compared between the two groups. The aim is to better understand how these widely used anesthesia techniques may influence recovery in VATS patients and to support future clinical decision-making.
Study Overview
Status
Detailed Description
This study is planned as a prospective observational cohort carried out in patients undergoing video-assisted thoracoscopic surgery (VATS). In routine practice at our institution, anesthesia for these operations is provided either with target-controlled infusion (TCI)-based total intravenous anesthesia or with inhalational agents. The study will not change the type of anesthesia given to any patient. The method used will depend entirely on the attending anesthesiologist's usual clinical choice.
Patients receiving either technique during the study period will be followed, and perioperative variables will be documented. These include basic demographic data, intraoperative hemodynamic changes, duration of anesthesia, administered drug doses, and oxygenation parameters. Postoperative recovery will be assessed mainly through awakening and extubation times, Aldrete scores, sedation assessments, pain scores, and early complications such as nausea and vomiting.
The purpose of this observational design is to compare the two commonly used anesthesia approaches as they are applied in real clinical practice. By examining postoperative recovery patterns and any differences between groups, the study aims to provide practical information that may help guide anesthesia selection in VATS procedures. No additional risk or intervention will be introduced, and all patient data will be collected in accordance with routine clinical monitoring.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: mert katılmış, md
- Phone Number: +905346430560
- Email: mertkatilmis97@gmail.com
Study Locations
-
-
Istanbul
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Istanbul, Istanbul, Turkey (Türkiye)
- Recruiting
- Istanbul University Cerrahpasa Medical Faculty
-
Contact:
- mert katılmış, medical doctor
- Phone Number: +905346430560
- Email: mertkatilmis97@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 18 to 65 years
Patients scheduled for elective video-assisted thoracoscopic surgery (VATS)
ASA physical status I-III
Able to provide informed consent
Planned postoperative recovery in PACU and surgical ward
Exclusion Criteria:
- ASA IV or higher
Hemodynamic or respiratory instability before surgery
Known allergy or contraindication to commonly used anesthetic agents
Neurological or psychiatric conditions that may interfere with recovery assessment
Emergency surgeries
Patients who decline participation
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
TCI Group
Patients receiving target-controlled infusion (TCI) anesthesia as part of routine clinical care during VATS procedures.
No intervention is assigned by the study team.
|
|
Inhalational Anesthesia Group
Patients receiving inhalational anesthesia (e.g., sevoflurane) as part of routine clinical care during VATS procedures.
No intervention is assigned by the study team.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Extubation Time
Time Frame: Up to 30 minutes after the end of surgery
|
Time from discontinuation of anesthesia to removal of the endotracheal tube.
Extubation time will be recorded routinely in the operating room as part of standard postoperative monitoring.
|
Up to 30 minutes after the end of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Awakening Time
Time Frame: Up to 20 minutes after surgery
|
Time from the end of anesthesia to the patient's first response to verbal command (eye opening or hand squeeze), recorded routinely in the operating room.
|
Up to 20 minutes after surgery
|
|
Aldrete Score Progression
Time Frame: PACU stay, up to 1 hour
|
Aldrete scores will be recorded at standard intervals in the post-anesthesia care unit (PACU) to evaluate early recovery.
The time needed to reach an Aldrete score of 9 will be compared between groups.
|
PACU stay, up to 1 hour
|
|
Postoperative Pain Score (NRS)
Time Frame: First hour after PACU admission
|
Numeric Rating Scale (0-10) will be used to assess postoperative pain at PACU admission and during the early postoperative period.
|
First hour after PACU admission
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- E-24687260-604.01-1455240
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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