- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01531491
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
Status
Completed
Intervention / Treatment
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.
Sponsor
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
Keywords
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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