Difference Between Inhalation Anesthesia and Total Intravenous Anesthesia in Free Flap Surgery

NCT ID: NCT03263078

Last Updated: 2022-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare the difference between total intravenous anesthesia to inhaled anesthesia in free flap surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The aim of this study is to perform a randomized controlled trial to examine the effects of different anesthetics on intraoperative hemodynamic stability during free flap surgery and postoperative complications

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TIVA with Propofol in free flap surgery

Total intravenous anesthesia(TIVA) with Propofol

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

For the maintenance of anesthesia, we used 2% propofol (Fresofol®, Fresenius Kabi, Germany) administered by the target controlled infusion (TCI) system (Orchestra® Base Primea; Fresenius Kabi, Germany) in Schnider mode with an effect concentration (Ce) of 2.5-3.5 µg ml-1

Sevoflurane in free flap surgery

Inhalation anesthesia with Sevoflurane

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

Anesthesia was maintained using 1-3% sevoflurane (ULTANE®, AbbVie Inc., USA) in the Sevoflurane group.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Propofol

For the maintenance of anesthesia, we used 2% propofol (Fresofol®, Fresenius Kabi, Germany) administered by the target controlled infusion (TCI) system (Orchestra® Base Primea; Fresenius Kabi, Germany) in Schnider mode with an effect concentration (Ce) of 2.5-3.5 µg ml-1

Intervention Type DRUG

Sevoflurane

Anesthesia was maintained using 1-3% sevoflurane (ULTANE®, AbbVie Inc., USA) in the Sevoflurane group.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patients who need head and neck cancer excision and free flap reconstruction surgery

Exclusion Criteria

1. preoperative cognitive dysfunction, NYHA CHF \> III or LVEF \< 30%
2. preoperative documented obstructive or restrictive lung disease
3. liver cirrhosis; severe chronic renal insufficiency (GFR \< 30 ml·min-1·1.73 m-2.)
4. peripheral arterial occlusive disease expected to be a contraindication for PiCCO catheter insertion
5. Active cardiac arrhythmias that were assumed to preclude valid assessment using arterial pulse contour analysis
6. anticipated bilateral femoral arterial and central venous catheterization when the jugular and subclavian veins were not available due to surgical extent
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yi-Ting Chang, MD

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology Department, Taichung Veterans General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Taichung Veterans General Hospital

Taichung, Taiwain, Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

References

Explore related publications, articles, or registry entries linked to this study.

Chang YT, Lai CS, Lu CT, Wu CY, Shen CH. Effect of Total Intravenous Anesthesia on Postoperative Pulmonary Complications in Patients Undergoing Microvascular Reconstruction for Head and Neck Cancer: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Sep 15;148(11):1013-21. doi: 10.1001/jamaoto.2022.2552. Online ahead of print.

Reference Type DERIVED
PMID: 36107412 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CF16113B

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Propofol vs Sevoflurane in Cardiac Surgery
NCT06729086 NOT_YET_RECRUITING NA