Continuous Spinal Anesthesia in Renal Transplantation

NCT03436368 | Active Not Recruiting DMC

• 1 other identifier: CSARTR60
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Anesthesia; Renal Failure Chronic; Transplant;Failure,Kidney

Keywords

Continuous spinal anesthesia; General anesthesia; Renal transplantation; Chronic renal failure

Outcome Measures

Primary Outcomes (1)

• Mean ABP

  Change in Mean Arterial Blood Pressure measured in mmHg.

  12 hours

Secondary Outcomes (2)

• Visual Analogue Score for pain "VAS"

  12 hours

• Patient satisfaction score

  24 hours

Study Arms (2)

CSA group

ACTIVE COMPARATOR

Continuous Spinal Anesthesia

Procedure: Continuous spinal anesthesia

GA group

ACTIVE COMPARATOR

General Anesthesia

Procedure: General anesthesia

Interventions

Continuous spinal anesthesia 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.

CSA group

General anesthesia 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.

GA group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA class III or IV
• End-stage renal disease
• Renal transplantation candidate patients

You may not qualify if:

• Any condition contra-indicating regional anesthesia
• Coagulopathy
• Allergic to any of the drugs used during the procedure

Sponsors & Collaborators

• Nazmy Edward Seif: lead

Study Sites (1)

Kasr Al-Ainy Hospital, Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Nazmy E Seif, MD

  Kasr Al-Ainy Hospital, Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Using computer \& sealed envelope randomization, patients are assigned to receive either continuous spinal anesthesia \[CSA group: n =30\] or general anesthesia \[GA group: n=30\]

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: February 19, 2018
• Study Start: February 20, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

EG (1)