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

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

Detailed Description
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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

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

Conditions
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Surgery

Intervention / Treatment
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* Drug: Propofol
* Drug: Sevoflurane


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients who need head and neck cancer excision and free flap reconstruction surgery Exclusion criteria: preoperative cognitive dysfunction, NYHA CHF > III or LVEF < 30% preoperative documented obstructive or restrictive lung disease liver cirrhosis; severe chronic renal insufficiency (GFR < 30 ml·min-1·1.73 m-2.) peripheral arterial occlusive disease expected to be a contraindication for PiCCO catheter insertion Active cardiac arrhythmias that were assumed to preclude valid assessment using arterial pulse contour analysis anticipated bilateral femoral arterial and central venous catheterization when the jugular and subclavian veins were not available due to surgical extent

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIVA with Propofol in free flap surgery<br>Total intravenous anesthesia(TIVA) with Propofol | Drug: Propofol<br>* 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<br>|
| Active Comparator: Sevoflurane in free flap surgery<br>Inhalation anesthesia with Sevoflurane | Drug: Sevoflurane<br>* Anesthesia was maintained using 1-3% sevoflurane (ULTANE®, AbbVie Inc., USA) in the Sevoflurane group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inhalation,intravenous anesthesia