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Effects of Hypercapnia on Emergence From General Anesthesia Under Propofol

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ClinicalTrials.gov Identifier: NCT01531491
Recruitment Status : Completed
First Posted : February 13, 2012
Last Update Posted : February 16, 2015
Sponsor:
Information provided by (Responsible Party):
Junyong In, MD, DongGuk University

Tracking Information
First Submitted Date  ICMJE February 6, 2012
First Posted Date  ICMJE February 13, 2012
Last Update Posted Date February 16, 2015
Study Start Date  ICMJE January 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2012)
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 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2012)
  • Time to breath spontaneously [ Time Frame: From cessation of propofol infusion to patient's spontaneous breathing (sec) ]
    After the caregiver stops propofol infusion when the patient regain spontaneous breaths, the time 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 stopping propofol infusion, every 30 seconds, the caregiver 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 10 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Hypercapnia on Emergence From General Anesthesia Under Propofol
Official Title  ICMJE Effects of Hypercapnia on Emergence From General Anesthesia Under Propofol: a Pilot Study
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Condition  ICMJE
  • Anesthesia, Intravenous
  • Anesthesia Recovery Period
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Rebreathing tube
  • 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.
    Intervention: Procedure: No rebreathing tube (Nothing)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2013)
30
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2012)
32
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01531491
Other Study ID Numbers  ICMJE J In 2011-3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Junyong In, MD, DongGuk University
Study Sponsor  ICMJE DongGuk University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Junyong In, M.D. Department of anesthesiology and pain medicine, Dongguk University Ilsan Hospital
PRS Account DongGuk University
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP