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.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Drug: Propofol; Drug: Sevoflurane

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

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taiwain
    • Taichung, Taiwain, Taiwan, 407
      • Taichung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TIVA with Propofol in free flap surgery; Total intravenous anesthesia(TIVA) with Propofol	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
ACTIVE_COMPARATOR: Sevoflurane in free flap surgery; Inhalation anesthesia with Sevoflurane	Drug: Sevoflurane; Anesthesia was maintained using 1-3% sevoflurane (ULTANE®, AbbVie Inc., USA) in the Sevoflurane group.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital
• Investigators: Principal Investigator: Yi-Ting Chang, MD, Anesthesiology Department, Taichung Veterans General Hospital

Publications and helpful links

General Publications

• Chang YT, Lai CS, Lu CT, Wu CY, Shen CH. Effect of Total Intravenous Anesthesia on Postoperative Pulmonary Complications in Patients Undergoing Microvascular Reconstruction for Head and Neck Cancer: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Sep 15;148(11):1013-21. doi: 10.1001/jamaoto.2022.2552. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2017
• Primary Completion (ACTUAL): October 30, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (ACTUAL): August 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: inhalation,intravenous anesthesia
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Sevoflurane
• Other Study ID Numbers: CF16113B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No