Effects of Hypercapnia on Emergence From General Anesthesia Under Propofol

February 12, 2015 updated by: Junyong In, MD, DongGuk University

Effects of Hypercapnia on Emergence From General Anesthesia Under Propofol: a Pilot Study

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kyunggido
      • Goyang, Kyunggido, Korea, Republic of, 140-773
        • Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From cessation of propofol infusion to patient's eye opening (seconds)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From cessation of propofol infusion to patient's spontaneous breathing (sec)
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.
From the cessation of propofol infusion to extubation, BIS and time (seconds) will be recorded.
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.
From cessation of propofol infusion to patient's mouth opening (seconds)
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.
From cessation of propofol infusion to extubation (sec)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

February 6, 2012

First Submitted That Met QC Criteria

February 10, 2012

First Posted (Estimate)

February 13, 2012

Study Record Updates

Last Update Posted (Estimate)

February 16, 2015

Last Update Submitted That Met QC Criteria

February 12, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J In 2011-3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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