Anesthesia, IntravenousNCT01531491
Effects of Hypercapnia on Emergence From General Anesthesia Under Propofol
A study testing Rebreathing tube and No rebreathing tube (Nothing) in people with Anesthesia, Intravenous and Anesthesia Recovery Period, run by DongGuk University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Anesthesia, Intravenous, Anesthesia Recovery Period
- What is being tested?
- Rebreathing tube and No rebreathing tube (Nothing)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital
Goyang, Kyunggido, 140-773
About this study
Official title: 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.
- Being tested
- Rebreathing tube, No rebreathing tube (Nothing)
- Keywords
- Emergence, Hypercapnia, Hypocapnia, Propofol
- Medical subject headings
- Hypercapnia, Hypocapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebreathing tubeProcedure or surgery
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.
No rebreathing tube (Nothing)Procedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Hypercapnia group | Experimental | 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. Receives: Procedure: Rebreathing tube |
| Hypocapnia group | Experimental | 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. Receives: Procedure: No rebreathing tube (Nothing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to open eyes under investigator's command
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.
Measured: From cessation of propofol infusion to patient's eye opening (seconds)
Secondary outcomes (4)
Time to breath spontaneously
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.
Measured: From cessation of propofol infusion to patient's spontaneous breathing (sec)
Change of bispectral index (BIS)
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.
Measured: From the cessation of propofol infusion to extubation, BIS and time (seconds) will be recorded.
Time to open mouth under investigator's command
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.
Measured: From cessation of propofol infusion to patient's mouth opening (seconds)
Time to extubation
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.
Measured: From cessation of propofol infusion to extubation (sec)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, IntravenousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- DongGuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junyong In, MD, DongGuk University
- Investigators
- Junyong In, M.D., Principal investigator, Department of anesthesiology and pain medicine, Dongguk University Ilsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531491
- Sponsor's protocol ID
- J In 2011-3
- Status last verified
- Feb 2015
- First submitted
- 6 Feb 2012
- Last updated
- 16 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hypercapnia on Emergence From General Anesthesia Under Propofol: a Pilot Study
- ClinicalTrials.gov ID
- NCT01531491
- Acronym / sponsor ID
- J In 2011-3
- Keywords
- Emergence, Hypercapnia, Hypocapnia, Propofol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- DongGuk UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 13 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypercapnia group | Experimental | Procedure: Rebreathing tubeRespiratory 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. |
| Hypocapnia group | Experimental | Procedure: No rebreathing tube (Nothing)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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rebreathing tube750 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 or surgery | Hypercapnia group |
| 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. | Procedure or surgery | Hypocapnia group |
Primary outcome
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.
4 secondary outcomes
Time to breath spontaneously
Time frame: 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.
Time to open mouth under investigator's command
Time frame: From cessation of propofol infusion to patient's mouth opening (seconds)
Time to extubation
Time frame: From cessation of propofol infusion to extubation (sec)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junyong In, M.D. principal investigator
Department of anesthesiology and pain medicine, Dongguk University Ilsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rebreathing tube and No rebreathing tube (Nothing) in people with Anesthesia, Intravenous and Anesthesia Recovery Period, run by DongGuk University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to open eyes under investigator's command (time frame: From cessation of propofol infusion to patient's eye opening (seconds)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2015.