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The Surgical Pleth index (SPI) has been introduced as a non invasive tool to "measure" stress and pain during surgery. Preliminary studies were performed in patients under general anaesthesia with propofol and remifentanil. These trials showed a good correlation between SPI and aching procedures and a negative correlation between SPI and the remifentanil dosage. Hence, it was concluded that SPI may be a bedside tool to measure 'pain' during surgery. So far, no study investigated SPI during regional anaesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General Anesthesia | Patients undergoing short-term surgery (30-90 min) under general anesthesia | ||
| Spinal | Patients undergoing short-term surgery (30-90 min) under spinal anesthesia | ||
| Spinal + Sedation | Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference Between All Groups for the Surgical Pleth Index(SPI) at Defined Timepoints | Surgical Pleth Index (SPI), derived from finger photoplethysmographic signal has a range from 0 showing the lowest stress level to 100 showing the maximum stress level. SPI was compared between the groups during six defined time points: baseline (BL)- day before surgery; induction (IND)-before induction of general anesthesia or before spinal punction respectively; intubation (INT) or spinal punction (SPA); skin incision (INC), surgical suture (SU) and 10 minutes after admission to the recovery room (PACU). Difference between the groups is calculated using ANOVA. | Time points for outcome measures: Baseline, before Induction of anesthesia, during Intubation or Spinal Punction, during Skin Incision, during Surgical Suture, during Post Anesthesia Care Unit stay |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for short-term (30-90 min) surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Berthold Bein, PD Dr med | Institut für Anästhesiologie und operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel | Kiel | 24105 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | General Anesthesia | Patients undergoing short-term surgery (30-90 min) under general anesthesia |
| FG001 | Spinal | Patients undergoing short-term surgery (30-90 min) under spinal anesthesia |
| FG002 | Spinal + Sedation | Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | General Anesthesia | Patients undergoing short-term surgery (30-90 min) under general anesthesia |
| BG001 | Spinal | Patients undergoing short-term surgery (30-90 min) under spinal anesthesia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference Between All Groups for the Surgical Pleth Index(SPI) at Defined Timepoints | Surgical Pleth Index (SPI), derived from finger photoplethysmographic signal has a range from 0 showing the lowest stress level to 100 showing the maximum stress level. SPI was compared between the groups during six defined time points: baseline (BL)- day before surgery; induction (IND)-before induction of general anesthesia or before spinal punction respectively; intubation (INT) or spinal punction (SPA); skin incision (INC), surgical suture (SU) and 10 minutes after admission to the recovery room (PACU). Difference between the groups is calculated using ANOVA. | Posted | Median | Standard Error | SPI and delta SPI (to baseline) | Time points for outcome measures: Baseline, before Induction of anesthesia, during Intubation or Spinal Punction, during Skin Incision, during Surgical Suture, during Post Anesthesia Care Unit stay |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | General Anesthesia | Patients undergoing short-term surgery (30-90 min) under general anesthesia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christoph Ilies M.D. | Institut für Anästhesiologie und Operative Intensivmedizin, Universitätsklinukum Schleswig-Holstein, Campus Kiel | +49-431-597 | 2991 | christoph.ilies@anaesthesie.uni-kiel.de |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| BG002 | Spinal + Sedation | Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients undergoing short-term surgery (30-90 min) under general anesthesia
| OG001 | Spinal | Patients undergoing short-term surgery (30-90 min) under spinal anesthesia |
| OG002 | Spinal + Sedation | Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation |
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Spinal | Patients undergoing short-term surgery (30-90 min) under spinal anesthesia | 0 | 20 | 0 | 20 |
| EG002 | Spinal + Sedation | Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation | 0 | 28 | 0 | 28 |
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |