Ventilatory Effect on Speed of Anesthesia Under Various Inhaled Anesthetics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Junyong In, DongGuk University
ClinicalTrials.gov Identifier:
NCT01171833
First received: July 28, 2010
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

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).


Condition Intervention
Pharmacokinetics of Inhaled Anesthetics
Drug: Sevoflurane
Drug: Desflurane
Drug: Isoflurane

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effect of Ventilation on Speed of Induction of Anesthesia in Desflurane, Sevoflurane, and Isoflurane

Resource links provided by NLM:


Further study details as provided by DongGuk University:

Primary Outcome Measures:
  • End-tidal concentrations of isoflurane, sevoflurane and desflurane, and BIS values with hypo-, normo-, hyperventilation [ Time Frame: at 0, 30, 60, 90, 120, 180, 240, 300, 360, 480, 600, 720 sec after volatile gas starts ] [ Designated as safety issue: Yes ]
    The inspiratory, and end-tidal concentrations of volatile anesthetics, partial pressure of end-tidal carbon dioxide will be recorded from an S/5 Avance anesthetic workstation (Datex-Ohmeda) and an embedded monitor. BIS values are measured with a BIS monitor.


Enrollment: 36
Study Start Date: June 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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)

Drug: Sevoflurane
2.0 vol% prefilled in a corrugated circuit.
Other Name: Sevorane
Experimental: 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)

Drug: Desflurane
6.0 vol% prefilled in a corrugated circuit.
Other Name: Suprane
Experimental: 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)

Drug: Isoflurane
1.2 vol% prefilled in a corrugated circuit.
Other Name: Aerane

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).

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01171833

Sponsors and Collaborators
DongGuk University
Investigators
Principal Investigator: Junyong In, MD Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital
  More Information

No publications provided

Responsible Party: Junyong In, Assistant professor, DongGuk University
ClinicalTrials.gov Identifier: NCT01171833     History of Changes
Other Study ID Numbers: J In 2010-1
Study First Received: July 28, 2010
Last Updated: August 9, 2012
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board

Keywords provided by DongGuk University:
Anesthetic induction
Desflurane
Isoflurane
Sevoflurane
Ventilation

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Anesthetics
Isoflurane
Desflurane
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on July 29, 2014