Delayed Recovery From AnaesthesiaPhase 24CRTNCT02232139
Measurement of Psychomotor Recovery After Anesthesia Using 4CRT
A Phase 2 study testing Midazolam in people with Delayed Recovery From Anaesthesia, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
The aim of the investigation is to validate the SmartPhone-based 4-Reaction Choice Time Test (4CRT) as a measure for recovery of the psychomotor function in patients after general anesthesia. Read more about this study
- Who is it for?
- Ages 19 to 50 years, women only
- Conditions the study is for
- Delayed Recovery From Anaesthesia
- What is being tested?
- Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2016to 25 Jun 2019
- Phase
- Phase 2
- 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 19 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Physical status I-III according to American Society of Anesthesiology
- ambulatory gynecologic surgery of 10-40 min
- patient is able to use VAS and to use SmartPhone-based 4CRT
- given informed consent
Who cannot join
- age < 18 or > 50 years
- patients who are not able to give their informed consent
- surgery lasts more than 40 min.
- history of psychopharmaceuticals or analgesics
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology, Intensive Care Medicine, Emergency Medicine and Pain Therapy
Dresden, Saxony, 01067
About this study
Official title: Measurement of Psychomotor Function Recovery in Patients After General Anesthesia Using 4-Choice Reaction Time Test
The aim of the investigation is to validate the SmartPhone-based 4-Reaction Choice Time Test (4CRT) as a measure for recovery of the psychomotor function in patients after general anesthesia. One hundred female patients, scheduled to ambulatory gynecological surgery in general anesthesia, will be randomized to the group with pharmacological anxiolytic premedication with midazolam (N=50) and to the group without midazolam (N=50). All patients will be monitored using 4CRT before and after standardized general anesthesia. The reaction time, measured with 4CRT is the primary outcome parameter of the investigation.
Read the detailed description
4CRT is a classical psychological test, used to measure the psychomotor speed. This test measures choice reaction time. The participants are instructed to respond by pressing the keys 1-4 of the keyboard, corresponding to the numbers, appearing on the screen of computer (PDA, SmartPhone). The average of the response latency, measured during the 10 trials is usually taken as 4CRT outcome.
- Conditions
- Delayed Recovery From Anaesthesia
- Being tested
- Midazolam
- 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.
MidazolamDrug
Also called Dormicum
The participants receive the pharmacological premedication before the surgery anyway
| Study group | Role | What they receive |
|---|---|---|
| Standard therapy group | No intervention | Participant who will not receive midazolam for pharmacological anxiolytic premedication before general surgery |
| Midazolam group | Experimental | Participant who will receive midazolam for pharmacological anxiolytic premedication before general surgery Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of four choice reaction time from baseline
One time immediately before the surgery and 6 times within 2 hours after the surgery for each participant
Measured: One time before the surgery and 2 hours after the surgery
Secondary outcomes (1)
Concentration of midazolam in serum
Measured: Within 2 hours after the surgery only in 40 (20 from each group) participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startMar 2016
- Primary completion25 Jun 2019
- Study completion25 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Delayed Recovery From AnaesthesiaStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Anesthesiology, Hospital Dresden-Friedrichstadt, Dresden, Germany
- Responsible party
- Sponsor
- Investigators
- Taras I Usichenko, MD, PhD, Study director, University Medicine of Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232139
- Sponsor's protocol ID
- BR-87/13-1
- Other IDs
- EK-BR-87/13-1
- Acronym
- 4CRT
- Status last verified
- Jan 2021
- First submitted
- 28 Aug 2014
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Zuurmond WW, Balk VA, van Dis H, van Leeuwen L, Paul EA. Multidimensionality of psychological recovery from anaesthesia. Analysing six recovery tests. Anaesthesia. 1989 Nov;44(11):889-92. doi: 10.1111/j.1365-2044.1989.tb09141.x.
PubMed 2596654
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Psychomotor Function Recovery in Patients After General Anesthesia Using 4-Choice Reaction Time Test
- ClinicalTrials.gov ID
- NCT02232139
- Acronym / sponsor ID
- 4CRT / BR-87/13-1
- Conditions
- Delayed Recovery From Anaesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- Department of Anesthesiology, Hospital Dresden-Friedrichstadt, Dresden, Germany
- Study start
- Mar 2016 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 5 Sep 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 aim of the investigation is to validate the SmartPhone-based 4-Reaction Choice Time Test (4CRT) as a measure for recovery of the psychomotor function in patients after general anesthesia. One hundred female patients, scheduled to ambulatory gynecological surgery in general anesthesia, will be randomized to the group with pharmacological anxiolytic premedication with midazolam (N=50) and to the group without midazolam (N=50). All patients will be monitored using 4CRT before and after standardized general anesthesia. The reaction time, measured with 4CRT is the primary outcome parameter of the investigation.
Detailed description
4CRT is a classical psychological test, used to measure the psychomotor speed. This test measures choice reaction time. The participants are instructed to respond by pressing the keys 1-4 of the keyboard, corresponding to the numbers, appearing on the screen of computer (PDA, SmartPhone). The average of the response latency, measured during the 10 trials is usually taken as 4CRT outcome.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard therapy group | No intervention | –Participant who will not receive midazolam for pharmacological anxiolytic premedication before general surgery |
| Midazolam group | Experimental | Drug: MidazolamParticipant who will receive midazolam for pharmacological anxiolytic premedication before general surgery |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Physical status I-III according to American Society of Anesthesiology
- ambulatory gynecologic surgery of 10-40 min
- patient is able to use VAS and to use SmartPhone-based 4CRT
- given informed consent
Key exclusion criteria (4 listed)
- age < 18 or > 50 years
- patients who are not able to give their informed consent
- surgery lasts more than 40 min.
- history of psychopharmaceuticals or analgesics
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 |
|---|---|---|
| MidazolamAlso: DormicumThe participants receive the pharmacological premedication before the surgery anyway | Drug | Midazolam group |
Primary outcome
Change of four choice reaction time from baseline
Time frame: One time before the surgery and 2 hours after the surgery
One time immediately before the surgery and 6 times within 2 hours after the surgery for each participant
1 secondary outcome
Concentration of midazolam in serum
Time frame: Within 2 hours after the surgery only in 40 (20 from each group) participants
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 11 Jan 2021.
- Background: PubMed 2596654Zuurmond WW, Balk VA, van Dis H, van Leeuwen L, Paul EA. Multidimensionality of psychological recovery from anaesthesia. Analysing six recovery tests. Anaesthesia. 1989 Nov;44(11):889-92. doi: 10.1111/j.1365-2044.1989.tb09141.x.
- Individual participant dataSharing planned: Undecided
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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.
Taras I Usichenko, MD, PhD study director
University Medicine of Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Midazolam in people with Delayed Recovery From Anaesthesia, run by University Medicine Greifswald at 1 site in Germany.
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 4 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 11 Jan 2021. 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 Germany. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change of four choice reaction time from baseline (time frame: One time before the surgery and 2 hours after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02232139, which also lists 1 linked publication.
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 11 Jan 2021.