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

Primary Purpose

Surgery

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Propofol
Sevoflurane
Sponsored by
Taichung Veterans General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Surgery focused on measuring inhalation,intravenous anesthesia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taichung Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TIVA with Propofol in free flap surgery

Sevoflurane in free flap surgery

Arm Description

Total intravenous anesthesia(TIVA) with Propofol

Inhalation anesthesia with Sevoflurane

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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)
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)
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)

Full Information

First Posted
August 21, 2017
Last Updated
June 28, 2022
Sponsor
Taichung Veterans General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03263078
Brief Title
Difference Between Inhalation Anesthesia and Total Intravenous Anesthesia in Free Flap Surgery
Official Title
Difference Between Inhalation Anesthesia and Total Intravenous Anesthesia in Free Flap Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taichung Veterans General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery
Keywords
inhalation,intravenous anesthesia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TIVA with Propofol in free flap surgery
Arm Type
Experimental
Arm Description
Total intravenous anesthesia(TIVA) with Propofol
Arm Title
Sevoflurane in free flap surgery
Arm Type
Active Comparator
Arm Description
Inhalation anesthesia with Sevoflurane
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Anesthesia was maintained using 1-3% sevoflurane (ULTANE®, AbbVie Inc., USA) in the Sevoflurane group.
Primary Outcome Measure Information:
Title
Number of patients with postoperative pulmonary complication
Description
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 Outcome Measure Information:
Title
Mean arterial blood pressure, MAP (mmHg)
Description
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
Title
Cardiac index , CI (L·min-1·m-2))
Description
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
Title
Systemic vascular resistance index, SVRI (dynes · sec · cm-5)
Description
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
Title
Stroke Volume Variation , SVV (%)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Ting Chang, MD
Organizational Affiliation
Anesthesiology Department, Taichung Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taichung Veterans General Hospital
City
Taichung
State/Province
Taiwain
ZIP/Postal Code
407
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36107412
Citation
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.
Results Reference
derived

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

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