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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03263078

Enrollment

Registered

2017-08-28

Start date

2017-10-01

Completion date

2019-12-31

Last updated

2022-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Keywords

inhalation,intravenous anesthesia

Brief summary

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

Detailed description

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

Interventions

DRUGPropofol

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

DRUGSevoflurane

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with postoperative pulmonary complication	1 day	A radiologist who was unaware of the group assignment evaluated the images and confirmed any PPCs, such as pulmonary edema, pneumonia, pleural effusion or atelectasis

Secondary

Measure	Time frame	Description
Mean arterial blood pressure, MAP (mmHg)	1 day	Measure MAP hourly (T0: First data after monitor instrumentation, T1: first hour, T2: second hour, Tend: at the end of surgery) and compare the difference between groups)
Cardiac index , CI (L·min-1·m-2))	1 day	Measure CI hourly (T0: First data after monitor instrumentation, T1: first hour, T2: second hour, Tend: at the end of surgery) and compare the difference between groups)
Systemic vascular resistance index, SVRI (dynes · sec · cm-5)	1 day	Measure SVRI hourly (T0: First data after monitor instrumentation, T1: first hour, T2: second hour, Tend: at the end of surgery) and compare the difference between groups)
Stroke Volume Variation , SVV (%)	1 day	Measure SVV hourly (T0: First data after monitor instrumentation, T1: first hour, T2: second hour, Tend: at the end of surgery) and compare the difference between groups)

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026