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This clinical trial investigates the relationship between urine output and mean arterial pressure (MAP) during spinal anesthesia. The study aims to validate observations from animal models in humans by concurrently measuring hemoglobin levels, MAP, and urine output, focusing on the effects of Ringer's solution, to provide crucial insights into optimal fluid management during anesthesia with minimal complexity.
The proposed clinical trial aims to explore the relationship between urine output and mean arterial pressure (MAP) during spinal anesthesia, a subject that has not been thoroughly studied in humans despite previous research under general anesthesia. Studies have demonstrated that the diuretic response to intravenous volume loading, using Ringer's solution or 20% albumin, varies with MAP levels. Specifically, Ringer's solution shows a greater diuretic effect when MAP exceeds 70 mmHg, whereas 20% albumin is more effective at lower pressures. This differential response highlights the importance of considering MAP in the choice of fluid for managing hypovolemia and oliguria.
The study's relevance is highlighted by the physiological dynamics at play, particularly how high levels of anesthesia, which influence the sympathetic nervous system from the mid-thoracic region, might reduce MAP and consequently decrease urine output. While this hypothesis has been examined in animal studies, its validity in humans remains unconfirmed.
To address this, the trial will measure hemoglobin levels, MAP, and urine output simultaneously, aiming to establish a clear correlation among these variables during spinal anesthesia. This methodical approach seeks to yield significant insights with minimal additional effort, contrasting with the complexities inherent in more elaborate study designs.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marcaine 0.5% Solution for Injection | Drug | The study involves the administration of 0.5% Marcaine heavy for spinal anesthesia in patients undergoing vascular surgery. The aim is to assess how this anesthesia affects urine output relative to mean arterial pressure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Catheter-Assisted Urine Output Measurement Post-Spinal Anesthesia | Urine volume is accurately measured using a catheter connected to a graduated collection bag. This method tracks the accumulated volume at specific intervals, providing a precise assessment of renal function and fluid management efficacy following spinal anesthesia | 10, 20, 30, 40, 50, and 60 minutes post-surgical intervention. |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications to Spinal Anesthesia:
Procedures Not Amenable to Spinal Anesthesia:
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Adult patients requiring spinal anesthesia for vascular surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Robert Hahn, Professor | Karolinska Institutet: Stockholm, SE (Department of Clinical Sciences, Danderyd Hospital) Employment | Study Chair |
| Serban-Ion Bubenek-Turconi, Professor | CC Iliescu Cardiovascular Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases | Bucharest | 022328 | Romania |
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| ID | Term |
|---|---|
| D009846 | Oliguria |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D012996 | Solutions |
| D007267 | Injections |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |