Effects of Hypercapnia on Emergence From General Anesthesia Under Propofol

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

Tracking Information

• First Submitted Date: February 6, 2012
• First Posted Date: February 13, 2012
• Last Update Posted Date: February 16, 2015
• Study Start Date: January 2012
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: Effects of Hypercapnia on Emergence From General Anesthesia Under Propofol
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor)

Condition

• Anesthesia, Intravenous
• Anesthesia Recovery Period

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 28, 2013): 30
• Original Estimated Enrollment (submitted: February 10, 2012): 32
• Actual Study Completion Date: June 2013
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT01531491
• Other Study ID Numbers: J In 2011-3
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Junyong In, MD, DongGuk University
• Study Sponsor: DongGuk University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Junyong In, M.D.; Department of anesthesiology and pain medicine, Dongguk University Ilsan Hospital

• PRS Account: DongGuk University
• Verification Date: February 2015