Pulmonary Mechanics During Minimally Invasive Repair of Pectus Excavatum

Sponsor

The Catholic University of Korea (Other)

Overall Status

Unknown status

CT.gov ID

NCT01486953

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pectus Excavatum	Drug: Desflurane Drug: Sevoflurane	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Nov 1, 2011

Anticipated Primary Completion Date :

Apr 1, 2014

Anticipated Study Completion Date :

Apr 1, 2014

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

pulmonary mechanics [within the 2 hours during the surgery]
respiratory resistance dynamic and static lung compliance

Secondary Outcome Measures

complication [within 72 hours after sugery]
bronchospasm dyspnea pneumothorax

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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