NCT01486953

Brief Summary

The aim of the current study was to compare the effects of sevoflurane and desflurane on respiratory mechanics in patients undergoing repair of pectus excavatum.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

July 23, 2013

Status Verified

July 1, 2013

Enrollment Period

2.4 years

First QC Date

November 26, 2011

Last Update Submit

July 22, 2013

Conditions

Pectus Excavatum

Keywords

respiratory resistancelung compliancedesfluranesevoflurane

Outcome Measures

Primary Outcomes (1)

  • pulmonary mechanics

    respiratory resistance dynamic and static lung compliance

    within the 2 hours during the surgery

Secondary Outcomes (1)

  • complication

    within 72 hours after sugery

Study Arms (2)

sevoflurane

ACTIVE COMPARATOR

Anesthesia with sevoflurane

Drug: Sevoflurane

Desflurane

EXPERIMENTAL

Anesthesia with desflurane

Drug: Desflurane

Interventions

DesfluraneDRUG

Using random numbers, patients were divided into two groups to receive either sevoflurane or desflurane. After induction of anesthesia and intubation, the patient's lungs were ventilated in constant-flow VCV mode by an anesthetic Ventilator (Datex-Ohmeda, GE healthcare, Finland). Ventilator settings were tidal volume 10 ml/kg, inspiratory:expiratory (I:E) ratio 1:1.5, inspired oxygen concentration (FiO2) 0.5 with air, and 3 L/min of inspiratory fresh gas flow. End-inspiratory pause was set 20% of total breathing cycle. Positive end-expiratory pressure (PEEP) was not used. Respiratory rate was adjusted to maintain an end-tidal CO2 pressure of 33-35 mmHg. Patients received desflurane 6-7% for maintenance of anesthesia.

Desflurane
SevofluraneDRUG

Using random numbers, patients were divided into two groups to receive either sevoflurane or desflurane. After induction of anesthesia and intubation, the patient's lungs were ventilated in constant-flow VCV mode by an anesthetic Ventilator (Datex-Ohmeda, GE healthcare, Finland). Ventilator settings were tidal volume 10 ml/kg, inspiratory:expiratory (I:E) ratio 1:1.5, inspired oxygen concentration (FiO2) 0.5 with air, and 3 L/min of inspiratory fresh gas flow. End-inspiratory pause was set 20% of total breathing cycle. Positive end-expiratory pressure (PEEP) was not used. Respiratory rate was adjusted to maintain an end-tidal CO2 pressure of 33-35 mmHg. Patients received sevoflurane 2-2.5% for maintenance of anesthesia.

sevoflurane

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of Pectus Excavatum
  • undergoing minimally invasive repair

You may not qualify if:

  • younger than 15 year old
  • history of upper respiratory tract infection within recent 2 weeks
  • asthma
  • chronic obstructive pulmonary disease
  • previous treatment with bronchoactive drugs (B-agonist or antagonist, theophyline, anticholinergics and corticosteroid)
  • history of neurological deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, 137-040, South Korea

RECRUITING

MeSH Terms

Conditions

Funnel Chest

Interventions

DesfluraneSevoflurane

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ethyl EthersEthersOrganic ChemicalsMethyl EthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Jeong Eun Kim, M.D, Ph.D

    Department of Anesthesiology, The Catholic University of Korea, Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeong Eun Kim, M.D, Ph.D

CONTACT

82-2-2258-6163moroo0201@catholic.ac.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

November 26, 2011

First Posted

December 7, 2011

Study Start

November 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

July 23, 2013

Record last verified: 2013-07

Locations

KR(1)