Continuous Spinal Anesthesia in Renal Transplantation

NCT ID: NCT03436368

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-20
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Renal Failure Chronic; Transplant;Failure,Kidney; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

CSA group

Continuous Spinal Anesthesia

Group Type: ACTIVE_COMPARATOR

Continuous spinal anesthesia

Intervention Type: PROCEDURE

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.

GA group

General Anesthesia

Group Type: ACTIVE_COMPARATOR

General anesthesia

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nazmy Edward Seif

OTHER

Sponsor Role: lead

Responsible Party

Nazmy Edward Seif

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nazmy E Seif, MD

Role: STUDY_CHAIR

Kasr Al-Ainy Hospital, Cairo University

Locations

Kasr Al-Ainy Hospital, Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

CSARTR60

Identifier Type: -

Identifier Source: org_study_id