Delayed Emergence From AnesthesiaNCT02149745
Effect of Calling the Patient's Name on Recovery From General Anesthesia
A study testing Calling the patient's name and Not calling the patient's name in people with Delayed Emergence From Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to find if we can shorten the recovery time by calling the patient's name during anesthesia reversal. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Delayed Emergence From Anesthesia
- What is being tested?
- Calling the patient's name and Not calling the patient's name
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Nov 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient aged between 20-70
- patient receiving breast cancer surgery under general anesthesia with total intravenous anesthesia using remifentanil and propofol, and intubated with LMA
Who cannot join
- refusal of consent
- patients taking CNS stimulants
- general anesthesia with other agents than propofol and remifentanil
- intubated with other equipments than LMA
- chronic alcoholic patient
- patients with convulsive disorder
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to find if we can shorten the recovery time by calling the patient's name during anesthesia reversal.
- Conditions
- Delayed Emergence From Anesthesia
- Being tested
- Calling the patient's name, Not calling the patient's name
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calling the patient's nameProcedure or surgery
calling the patient's name during anesthesia reversal
Not calling the patient's nameProcedure or surgery
giving verbal stimulus other than the patient's name during anesthesia reversal
| Study group | Role | What they receive |
|---|---|---|
| Calling the patient's name | Experimental | The anesthesiologist tries to recover the patient's consciousness by calling the patient's name Receives: Procedure: Calling the patient's name |
| Not calling the patient's name | Experimental | The anesthesiologist tries to recover the patient's consciousness by giving verbal stimulus other than the patient's name Receives: Procedure: Not calling the patient's name |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in recovery time between the two groups
difference in recovery time (eye opening time, extubation time) after stopping injection of anesthetics, and the time when the patient's bispectral index value displayed on the monitor is above 60
Measured: 1 min,2 min,3 min, 4min, 5min, 6min, 7min, 8min, 9min, 10min after stopping injection of anesthetics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Emergence From AnesthesiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-Hwa Seo, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149745
- Sponsor's protocol ID
- JHSeo_Calling
- Status last verified
- Jun 2017
- First submitted
- 8 May 2014
- Last updated
- 2 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Calling the Patient's Name on Recovery From General Anesthesia
- ClinicalTrials.gov ID
- NCT02149745
- Acronym / sponsor ID
- JHSeo_Calling
- Conditions
- Delayed Emergence From Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 29 May 2014 (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.
The purpose of this study is to find if we can shorten the recovery time by calling the patient's name during anesthesia reversal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calling the patient's name | Experimental | Procedure: Calling the patient's nameThe anesthesiologist tries to recover the patient's consciousness by calling the patient's name |
| Not calling the patient's name | Experimental | Procedure: Not calling the patient's nameThe anesthesiologist tries to recover the patient's consciousness by giving verbal stimulus other than the patient's name |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient aged between 20-70
- patient receiving breast cancer surgery under general anesthesia with total intravenous anesthesia using remifentanil and propofol, and intubated with LMA
Key exclusion criteria (6 listed)
- refusal of consent
- patients taking CNS stimulants
- general anesthesia with other agents than propofol and remifentanil
- intubated with other equipments than LMA
- chronic alcoholic patient
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 |
|---|---|---|
| Calling the patient's namecalling the patient's name during anesthesia reversal | Procedure or surgery | Calling the patient's name |
| Not calling the patient's namegiving verbal stimulus other than the patient's name during anesthesia reversal | Procedure or surgery | Not calling the patient's name |
Primary outcome
Difference in recovery time between the two groups
Time frame: 1 min,2 min,3 min, 4min, 5min, 6min, 7min, 8min, 9min, 10min after stopping injection of anesthetics
difference in recovery time (eye opening time, extubation time) after stopping injection of anesthetics, and the time when the patient's bispectral index value displayed on the monitor is above 60
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 2 Jun 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calling the patient's name and Not calling the patient's name in people with Delayed Emergence From Anesthesia, run by Seoul National University Hospital 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 2 inclusion and 6 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 2 Jun 2017. 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?
Difference in recovery time between the two groups (time frame: 1 min,2 min,3 min, 4min, 5min, 6min, 7min, 8min, 9min, 10min after stopping injection of anesthetics). 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 2 Jun 2017.