Continuous Spinal Anesthesia in Renal Transplantation

Anesthesia Clinical Trial

Official title:

Continuous Spinal Anesthesia for Renal Transplant Recipients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03436368
• Other study ID #: CSARTR60
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 20, 2018
• Est. completion date: July 2024

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Kidney Failure, Chronic
• Renal Failure Chronic
• Renal Insufficiency
• Transplant;Failure,Kidney

Intervention

Procedure:
• Continuous spinal anesthesia
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.
• General anesthesia
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.

Locations

Country	Name	City	State
Egypt	Kasr Al-Ainy Hospital, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Nazmy Edward Seif

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean ABP	Change in Mean Arterial Blood Pressure measured in mmHg.	12 hours
Secondary	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
Secondary	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