Pulmonary Mechanics During Minimally Invasive Repair of Pectus Excavatum

Phase 4 Study of Desflurane and Sevoflurane That Affect Pulmonary Mechanics During Minimally Invasive Repair of Pectus Excavatum

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.

Study Overview

• Status: Unknown
• Conditions: Pectus Excavatum
• Intervention / Treatment: Drug: Sevoflurane; Drug: Desflurane

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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jeong Eun Kim, M.D, Ph.D; Phone Number: 82-2-2258-6163; Email: moroo0201@catholic.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 137-040
    • Recruiting
    • Seoul st. mary's hospital
    • Contact: Jeong Eun Kim, M.D, Ph.D; Phone Number: 82-2-2258-6163; Email: moroo0201@gmail.com
    • Principal Investigator: Jeong Eun Kim, M.D, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pulmonary mechanics	respiratory resistance dynamic and static lung compliance	within the 2 hours during the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complication	bronchospasm dyspnea pneumothorax	within 72 hours after sugery

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ANTICIPATED): April 1, 2014
• Study Completion (ANTICIPATED): April 1, 2014

Study Registration Dates

• First Submitted: November 26, 2011
• First Submitted That Met QC Criteria: December 5, 2011
• First Posted (ESTIMATE): December 7, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 23, 2013
• Last Update Submitted That Met QC Criteria: July 22, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: sevoflurane; desflurane; lung compliance; respiratory resistance
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Bone Diseases; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Funnel Chest; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Desflurane; Sevoflurane
• Other Study ID Numbers: pectus-study