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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03263078
• Other study ID #: CF16113B
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2022
• Source: Taichung Veterans General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 31, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Aspiration
• Surgery

Intervention

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

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung	Taiwain

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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