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Completed

NCT Number: NCT03263078

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

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

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Key information

Conditions

Surgery Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taichung Veterans General Hospital

Taichung, Taiwain, 407, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

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

Drug

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

Primary outcomes

  1. Number of patients with postoperative pulmonary complication

    Time frame: 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 outcomes

  1. Mean arterial blood pressure, MAP (mmHg)

    Time frame: 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)

  2. Cardiac index , CI (L·min-1·m-2))

    Time frame: 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)

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

    Time frame: 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)

  4. Stroke Volume Variation , SVV (%)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 28, 2017
Registry last updated
Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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