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

Taichung Veterans General Hospital78 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Surgery

Interventions

PropofolDRUG

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

SevofluraneDRUG

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Taichung Veterans General Hospital

Taichung, Taiwain, Taiwan

Outcomes

Primary Outcomes

Number of patients with postoperative pulmonary complication

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

Time frame: 1 day

Secondary Outcomes

Mean arterial blood pressure, MAP (mmHg)

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)

Time frame: 1 day

Cardiac index , CI (L·min-1·m-2))

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)

Time frame: 1 day

Systemic vascular resistance index, SVRI (dynes · sec · cm-5)

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)

Time frame: 1 day

Stroke Volume Variation , SVV (%)

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)

Time frame: 1 day

Data from ClinicalTrials.gov

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