Ventilatory Effect on Speed of Anesthesia Under Various Inhaled Anesthetics

NCT ID: NCT01171833

Last Updated: 2012-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2010-10-31

Brief Summary

Three groups of patients are going to have minor surgery under general anesthesia with inhaled anesthetics and different ventilatory setting (Tidal volume: 8, 10, 12 ml/kg, respiratory rate: 10/min each). Group A (Sevoflurane) will use sevoflurane, group B (Desflurane) will use desflurane, and group C (Isoflurane) will use isoflurane. It will be observed differences among the groups for ventilatory effects on speed of induction.

Duration of this randomised controlled trial will be about 3 months. Estimated sample size will be 36 patients(12 in each group).

Detailed Description

No premedicant will be given. The anesthetic workstation and a circulatory circuit will be prefilled with 1.0 MAC of inhaled anesthetic that will be selected randomly.

• Group A (n=12): Sevoflurane 2.0 vol%
• Group B (n=12): Desflurane 6.0 vol%
• Group C (n=12): Isoflurane 1.2 vol%

Each group has 3 subgroups according to the ventilatory setting that will also be randomly determined.

• Hypoventilation: tidal volume 8 ml/kg, respiratory rate 10 /min
• Normoventilation: tidal volume 10 ml/kg, respiratory rate 10 /min
• Hyperventilation: tidal volume 12 ml/kg, respiratory rate 10 /min

Patients will be preoxygenated with 100% oxygen (5 L/min) for 5 minutes under pulse oximeter, EKG, and noninvasive blood pressure monitoring. Bispectral index (BIS) monitor will be applied.

The induction of general anesthesia will start with propofol (2 mg/kg), rocuronium (0.8 mg/kg) and remifentanil infusion (0.1 mcg/kg/min). The size of a tracheal tube will be 7.5 mm (ID) for male, 7.0 mm (ID) for female. After intubation, anesthesia workstation will be connected to the tracheal tube. Ventilation will start, and that point will be time 0. During 720 seconds, inspiratory (PIgas) and end-tidal concentration of inhaled anesthetics (ETgas), end-tidal partial pressure of carbon dioxide, and BIS will be measured at time 0, 30, 60, 90, 120 ,150, 180, 240, 300, 360, 480, 600, and 720 seconds. Mean blood pressure and heart rate will also be recorded every 2 minutes. Fresh gas flow will be kept at 6 L/min with 100% oxygen.

The fraction of ETgas/PIgas will be analyzed with nonlinear mixed effects modeling.

Estimated sample size will be 36 patients (12 in each group, 4 in each ventilatory settings).

Conditions

Pharmacokinetics of Inhaled Anesthetics

Keywords

Anesthetic induction; Desflurane; Isoflurane; Sevoflurane; Ventilation

Study Design

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

Study Groups

Group A(Sevoflurane)

Twelve patients will be enrolled in this group. They will be divided into subgroups with ventilatory settings.

Each subgroup has 4 patients.

A8: tidal volume(8 ml/kg) and respiratory rate(10 /min) A10: tidal volume(10 ml/kg) and respiratory rate(10 /min) A12: tidal volume(12 ml/kg) and respiratory rate(10 /min)

Group Type: EXPERIMENTAL

Sevoflurane

Intervention Type: DRUG

2.0 vol% prefilled in a corrugated circuit.

Group B(Desflurane)

Twelve patients will be enrolled in this group. They will be divided into subgroups with ventilatory settings.

Each subgroup has 4 patients.

A8: tidal volume(8 ml/kg) and respiratory rate(10 /min) A10: tidal volume(10 ml/kg) and respiratory rate(10 /min) A12: tidal volume(12 ml/kg) and respiratory rate(10 /min)

Group Type: EXPERIMENTAL

Desflurane

Intervention Type: DRUG

6.0 vol% prefilled in a corrugated circuit.

Group C(Isoflurane)

Twelve patients will be enrolled in this group. They will be divided into subgroups with ventilatory settings.

Each subgroup has 4 patients.

A8: tidal volume(8 ml/kg) and respiratory rate(10 /min) A10: tidal volume(10 ml/kg) and respiratory rate(10 /min) A12: tidal volume(12 ml/kg) and respiratory rate(10 /min)

Group Type: EXPERIMENTAL

Isoflurane

Intervention Type: DRUG

1.2 vol% prefilled in a corrugated circuit.

Interventions

Sevoflurane

2.0 vol% prefilled in a corrugated circuit.

Intervention Type: DRUG

Desflurane

6.0 vol% prefilled in a corrugated circuit.

Intervention Type: DRUG

Isoflurane

1.2 vol% prefilled in a corrugated circuit.

Intervention Type: DRUG

Other Intervention Names

Sevorane; Suprane; Aerane

Eligibility Criteria

Inclusion Criteria

• ASA PS I, II
• Age: 20-60 years male and female
• Elective schedule with minor surgery
• BMI < 30

Exclusion Criteria

• Patients with pulmonary, cardiac, endocrinal, neuromuscular and neurological diseases or past history
• Upper airway anomaly or deformity
• ASA PS III or higher
• Pregnant women
• BMI >= 30

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DongGuk University

OTHER

Sponsor Role: lead

Responsible Party

Junyong In

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Junyong In, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital

Other Identifiers

J In 2010-1

Identifier Type: -

Identifier Source: org_study_id