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| ID | Type | Description | Link |
|---|---|---|---|
| EK-BR-87/13-1 | Other Identifier | Ethics commission |
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| Name | Class |
|---|---|
| Department of Anesthesiology, Hospital Dresden-Friedrichstadt, Dresden, Germany | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | The participants receive the pharmacological premedication before the surgery anyway |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | One time before the surgery and 2 hours after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of midazolam in serum | Within 2 hours after the surgery only in 40 (20 from each group) participants |
| Measure | Description | Time Frame |
|---|---|---|
| Postanesthesia discharge scoring system | Within 2 hours after the surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taras I Usichenko, MD, PhD | University Medicine of Greifswald | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, Intensive Care Medicine, Emergency Medicine and Pain Therapy | Dresden | Saxony | 01067 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2596654 | Background | 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. |
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| ID | Term |
|---|---|
| D055191 | Delayed Emergence from Anesthesia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| D006571 | Heterocyclic Compounds |