Continuous Spinal Anesthesia in Renal Transplantation

Study Overview
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Brief Summary
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Renal transplantation is now recognized as a treatment of choice for patients with end-stage renal disease. An adequate anesthetic technique should achieve hemodynamic stability and enhance perfusion of the transplanted kidney. The aim of this study is to assess the use & effects of continuous spinal anesthesia for kidney transplantation recipients, compared with balanced general anesthesia.

Official Title
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Continuous Spinal Anesthesia for Renal Transplant Recipients

Conditions
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Renal Failure Chronic, Transplant;Failure,Kidney, Anesthesia

Intervention / Treatment
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* Procedure: Continuous spinal anesthesia
* Procedure: General anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA class III or IV End-stage renal disease Renal transplantation candidate patients Exclusion Criteria: Any condition contra-indicating regional anesthesia Coagulopathy Allergic to any of the drugs used during the procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Using computer & sealed envelope randomization, patients are assigned to receive either continuous spinal anesthesia [CSA group: n =30] or general anesthesia [GA group: n=30]
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CSA group<br>Continuous Spinal Anesthesia | Procedure: Continuous spinal anesthesia<br>* Continuous spinal anesthesia will be performed for patients of the CSA group at the L3-L4 intervertebral space using Spinocath (B. Braun, Melsungen, Germany). After the cerebrospinal fluid is aspirated, 7.5 mg hyperbaric Bupivacaine 0.5% (1.5 ml) together with 25 micrograms Fentanyl (0.5 ml) will be injected intra-thecally. Supplemental injections will be given in aliquots of 5 mg hyperbaric Bupivacaine 0.5% (1 ml) if the sensory block is lower or reseeds, during surgery, below T6 dermatome.<br>|
| Active Comparator: GA group<br>General Anesthesia | Procedure: General anesthesia<br>* Anesthesia will be induced with intra-venous administration of Fentanyl (2 micrograms/kg), Ptopofol (1-2 mg/kg) and Atracurium (0.5 mg/kg). Maintenance will be achieved with 0.8-1.5% Isoflurane in an O2 / air mixture, an Atracurium infusion at 0.5 mg/kg/hr and a Fentanyl infusion at 1 micrograms/kg/hr.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean ABP | Change in Mean Arterial Blood Pressure measured in mmHg. | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Score for pain VAS | Visual Analogue Score for pain measures the degree of pain experienced by the patient during the procedure. VAS is graded from 0-10 [where 0=no pain, 10= worst pain]. | 12 hours | 
| Patient satisfaction score | Patient satisfaction Score defines the degree of patient satisfaction with the anesthetic experience and is assessed after recovery. It is graded as excellent E (best score), fair F or poor P (worst score). | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous spinal anesthesia, General anesthesia, Renal transplantation, Chronic renal failure