Effects of Hypercapnia on Emergence From General Anesthesia Under Propofol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Junyong In, DongGuk University
ClinicalTrials.gov Identifier:
NCT01531491
First received: February 6, 2012
Last updated: July 28, 2013
Last verified: July 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Junyong In, Assistant professor, DongGuk University
ClinicalTrials.gov Identifier: NCT01531491     History of Changes
Other Study ID Numbers: J In 2011-3
Study First Received: February 6, 2012
Last Updated: July 28, 2013
Health Authority: Korea: Institutional Review Board
Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by DongGuk University:
Emergence
Hypercapnia
Hypocapnia
Propofol

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

ClinicalTrials.gov processed this record on October 20, 2014