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Effects of Hypercapnia on Emergence From General Anesthesia Under Propofol

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01531491
First Posted: February 13, 2012
Last Update Posted: February 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Junyong In, MD, DongGuk University
  Purpose
Hypercapnia derives increase of cerebral blood flow and cardiac output. It means that the rate of propofol elimination from the brain and the blood will be increased and the patient will awake more quickly. There has been no study about the effects of hypercapnia. The investigators will evaluate hypercapnia's effects on the recovery time from propofol anesthesia.

Condition Intervention
Anesthesia, Intravenous Anesthesia Recovery Period Procedure: Rebreathing tube Procedure: No rebreathing tube (Nothing)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: Effects of Hypercapnia on Emergence From General Anesthesia Under Propofol: a Pilot Study

Resource links provided by NLM:


Further study details as provided by Junyong In, MD, DongGuk University:

Primary Outcome Measures:
  • Time to open eyes under investigator's command [ Time Frame: From cessation of propofol infusion to patient's eye opening (seconds) ]
    After stopping propofol infusion, every 30 seconds, the investigator (caregiver) will command the patient, "Open your eyes". When the patient opens eyes, the time will be recorded. The patients will be followed for an expected average of 10 minutes.


Secondary Outcome Measures:
  • Time to breath spontaneously [ Time Frame: From cessation of propofol infusion to patient's spontaneous breathing (sec) ]
    The time from cessation of propofol infusion to patient's spontaneous breaths will be recorded. The patients will be followed for an expected average of 10 minutes.

  • Change of bispectral index (BIS) [ Time Frame: From the cessation of propofol infusion to extubation, BIS and time (seconds) will be recorded. ]
    After stopping propofol infusion, the BIS and time (seconds) will be recorded and reviewed. These will be recorded for an expected average of 15 minutes.

  • Time to open mouth under investigator's command [ Time Frame: From cessation of propofol infusion to patient's mouth opening (seconds) ]
    After the patient opens the eyes, every 10 seconds, the investigator command the patient, "Open your mouth.". When the patient opens mouth, the time will be recorded. The patients will be followed for an expected average of 12 minutes.

  • Time to extubation [ Time Frame: From cessation of propofol infusion to extubation (sec) ]
    After stopping propofol infusion, When the patient breaths spontaneously with adequate tidal volume and respiratory rates, the trachea will be extubated and the time will be recorded. The patients will be followed for an expected average of 15 minutes.


Enrollment: 30
Study Start Date: January 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hypercapnia group
Respiratory rate will be 10/min and the rebreathing tube will be connected between the y-piece of corrugated tube and the tracheal tube to maintain the partial pressure of the end-tidal carbon dioxide at around 50 mmHg during emergence after propofol anesthesia.
Procedure: Rebreathing tube
750 ml rebreathing tube will be connected between the corrugated tube and the tracheal tube of a patient. Target partial pressure of the end-tidal carbon dioxide is 50 mmHg.
Experimental: Hypocapnia group
No rebreathing tube (Nothing) will be connected. Respiratory rate will be 10/min and the tidal volume will be modulated to maintain the partial pressure of the end-tidal carbon dioxide at around 30 mmHg during emergence after propofol anesthesia.
Procedure: No rebreathing tube (Nothing)
750 ml rebreathing tube will not be connected between the corrugated tube and the tracheal tube of a patient. Target partial pressure of the end-tidal carbon dioxide is 30 mmHg.

  Eligibility

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists physical status (ASA PS) I-II
  • Age 20 - 60 years male and female
  • Elective schedule with minor surgery under general anesthesia

Exclusion Criteria:

  • Body mass index (BMI) >= 30 (kg/m2)
  • Patient with pulmonary, cardiac, endocrinal, neuromuscular and neurological diseases or past history
  • Patient with medication affecting on this study
  • Patient with general anesthesia history within one month
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531491


Locations
Korea, Republic of
Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital
Goyang, Kyunggido, Korea, Republic of, 140-773
Sponsors and Collaborators
DongGuk University
Investigators
Principal Investigator: Junyong In, M.D. Department of anesthesiology and pain medicine, Dongguk University Ilsan Hospital
  More Information

Responsible Party: Junyong In, MD, Associate professor, DongGuk University
ClinicalTrials.gov Identifier: NCT01531491     History of Changes
Other Study ID Numbers: J In 2011-3
First Submitted: February 6, 2012
First Posted: February 13, 2012
Last Update Posted: February 16, 2015
Last Verified: February 2015

Keywords provided by Junyong In, MD, DongGuk University:
Emergence
Hypercapnia
Hypocapnia
Propofol

Additional relevant MeSH terms:
Hypercapnia
Signs and Symptoms, Respiratory
Signs and Symptoms
Anesthetics
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General