NCT02324283

Brief Summary

Which is more adequate general anesthetic agent, desflurane or propofol, for emergence and recovery time, and perioperative oxygenation in lung resection surgery?

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

October 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
7.8 years until next milestone

Results Posted

Study results publicly available

April 5, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

3.7 years

First QC Date

December 15, 2014

Results QC Date

November 25, 2022

Last Update Submit

April 2, 2024

Conditions

Keywords

one-lung ventilation, oxygenation

Outcome Measures

Primary Outcomes (1)

  • Oxygenation

    Arterial blood gases are monitored.Pulmonary blood flow is measured using transesophageal echocardiogram.

    prior to surgery to one-hour after extubation

Secondary Outcomes (3)

  • Rapidity of Emergence From Anesthesia

    one minute after cessation of anethetic agents to one hour after extubation

  • Quality of Consiousness

    after extubation

  • Postoperative Nausea and Vomiting

    on the postoperative day 1

Study Arms (2)

Desflurane

ACTIVE COMPARATOR

Desflurane group: this group of patients receives desflurane as the main anesthetic agent in addition to remifentanil infusion at 0.1\~0.3 mcg/kg/min during one-lung anesthesia. Bispectral index will be maintained between 45 and 50. Arterial blood gases and pulmonary blood flow by using tansesphageal echocardiogrphy will be measured.

Drug: desflurane

Propofol

ACTIVE COMPARATOR

Propofol group: this group of patients receives propofol as the main anesthetic agent in addition to remifentanil infusion at the rate of 0.1\~0.3 mcg./g/min during one-lung anesthesia. Bispectral index will be maintained between 45 and 50. Arterial blood gases and pulmonary blood flow by using tansesphageal echocardiogrphy will be measured.

Drug: propofol

Interventions

Desflurane group: this group of patients receives desflurane as the main anesthetic agent during one-lung anesthesia. Propofol group: this group of patients receives propofol as the main anesthetic agnet during on-lung anesthesia.

Also known as: Suprene
Desflurane

Propofol group:this group of patients receives propofol as the main anesthetic agent during one-lung anesthesia.

Also known as: Diprivan
Propofol

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients agree to participate in the study
  • Patients undergoing lung cancer surgery requiring one-lung ventilation.
  • American Society of Anesthesiologists Physical Status Class 1 or 2

You may not qualify if:

  • Patients with any of the following will be excluded from lung cancer patients.
  • New York Heart Association Classification more than 2
  • Respiratory dysfunction Vital Capacity or percent predicted Forced expiratory volume in one second is less than 50 %
  • Pulmonary hypertension with mean pulmonary arterial pressure more than 30 mmHg
  • Coagulation dysfunction
  • The administration of steroids and immunosuppressive agents within 3 months prior to surgery
  • Infection with active inflammation
  • Pneumonectomy patients
  • Cases of epidural anesthesia is contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Juntendo

Bunkyō City, Tokyko, 113-8421, Japan

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

DesfluranePropofol

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ethyl EthersEthersOrganic ChemicalsMethyl EthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Results Point of Contact

Title
Dr. Izumi Kawagoe
Organization
Juntendo University

Study Officials

  • Eiichi Inada, M.D.

    Juntendo University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

December 15, 2014

First Posted

December 24, 2014

Study Start

October 1, 2012

Primary Completion

June 1, 2016

Study Completion

December 1, 2024

Last Updated

April 5, 2024

Results First Posted

April 5, 2024

Record last verified: 2024-04

Locations