Pulmonary Mechanics During Minimally Invasive Repair of Pectus Excavatum

NCT ID: NCT01486953

Last Updated: 2013-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-04-30

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.

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.

Conditions

Pectus Excavatum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

sevoflurane

Anesthesia with sevoflurane

Group Type: ACTIVE_COMPARATOR

Sevoflurane

Intervention Type: DRUG

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.

Desflurane

Anesthesia with desflurane

Group Type: EXPERIMENTAL

Desflurane

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Catholic University of Korea

OTHER

Sponsor Role: lead

Responsible Party

Jeong Eun Kim

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeong Eun Kim, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jeong Eun Kim, M.D, Ph.D

Role: CONTACT

moroo0201@catholic.ac.kr

82-2-2258-6163

Facility Contacts

Jeong Eun Kim, M.D, Ph.D

Role: primary

moroo0201@gmail.com

82-2-2258-6163

Other Identifiers

pectus-study

Identifier Type: -

Identifier Source: org_study_id