NCT03263078

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P25-P50 for not_applicable surgery

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

2.1 years

First QC Date

August 21, 2017

Last Update Submit

June 28, 2022

Conditions

Surgery

Keywords

inhalation,intravenous anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Mean arterial blood pressure, MAP (mmHg)

    1 day

  • Cardiac index , CI (L·min-1·m-2))

    1 day

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

    1 day

  • Stroke Volume Variation , SVV (%)

    1 day

Study Arms (2)

TIVA with Propofol in free flap surgery

EXPERIMENTAL

Total intravenous anesthesia(TIVA) with Propofol

Drug: Propofol

Sevoflurane in free flap surgery

ACTIVE COMPARATOR

Inhalation anesthesia with Sevoflurane

Drug: Sevoflurane

Interventions

PropofolDRUG

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

TIVA with Propofol in free flap surgery
SevofluraneDRUG

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

Sevoflurane in free flap surgery

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who need head and neck cancer excision and free flap reconstruction surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwain, 407, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 36107412DERIVED

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

PropofolSevoflurane

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Yi-Ting Chang, MD

    Anesthesiology Department, Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2017

First Posted

August 28, 2017

Study Start

October 1, 2017

Primary Completion

October 30, 2019

Study Completion

December 31, 2019

Last Updated

June 30, 2022

Record last verified: 2022-06

Locations

TW(1)