Pulmonary Mechanics During Minimally Invasive Repair of Pectus Excavatum

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by The Catholic University of Korea
Sponsor:
Information provided by (Responsible Party):
Jeong Eun Kim, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01486953
First received: November 26, 2011
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Pectus Excavatum
Drug: Desflurane
Drug: Sevoflurane
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Phase 4 Study of Desflurane and Sevoflurane That Affect Pulmonary Mechanics During Minimally Invasive Repair of Pectus Excavatum

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • pulmonary mechanics [ Time Frame: within the 2 hours during the surgery ] [ Designated as safety issue: Yes ]
    respiratory resistance dynamic and static lung compliance


Secondary Outcome Measures:
  • complication [ Time Frame: within 72 hours after sugery ] [ Designated as safety issue: Yes ]
    bronchospasm dyspnea pneumothorax


Estimated Enrollment: 70
Study Start Date: November 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: sevoflurane
Anesthesia with sevoflurane
Drug: Sevoflurane
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.
Experimental: Desflurane
Anesthesia with desflurane
Drug: Desflurane
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.

Detailed Description:

The minimally invasive technique for pectus excavatum repair was introduced by Nuss and colleagues using a metal bar to lift the depressed chest wall. This surgical procedure is usually done under general anesthesia with tracheal intubation. After inserting metal bar into the chest wall, decreased lung compliance was shown. Previous studies demonstrated that administering desflurane during anesthesia resulted in marked increases in respiratory mechanical parameters, especially in the children with airway susceptibility. Our primary hypothesis was that desflurane would cause an increase in respiratory resistance and a decrease in lung compliance compared to sevoflurane during repair of pectus excavatum.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of Pectus Excavatum
  • undergoing minimally invasive repair

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01486953

Contacts
Contact: Jeong Eun Kim, M.D, Ph.D 82-2-2258-6163 moroo0201@catholic.ac.kr

Locations
Korea, Republic of
Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 137-040
Contact: Jeong Eun Kim, M.D, Ph.D    82-2-2258-6163    moroo0201@gmail.com   
Principal Investigator: Jeong Eun Kim, M.D, Ph.D         
Sponsors and Collaborators
The Catholic University of Korea
Investigators
Principal Investigator: Jeong Eun Kim, M.D, Ph.D Department of Anesthesiology, The Catholic University of Korea, Seoul St. Mary's Hospital
  More Information

No publications provided

Responsible Party: Jeong Eun Kim, Clinical Assistant Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01486953     History of Changes
Other Study ID Numbers: pectus-study
Study First Received: November 26, 2011
Last Updated: July 22, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by The Catholic University of Korea:
respiratory resistance
lung compliance
desflurane
sevoflurane

Additional relevant MeSH terms:
Funnel Chest
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Sevoflurane
Desflurane
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014