CClinicalTrials.gg
Active, not recruitingNCT03436368Updated Jan 12, 2026

Continuous Spinal Anesthesia in Renal Transplantation

An interventional study of Continuous spinal anesthesia and General anesthesia in Renal Failure Chronic, Transplant;Failure,Kidney and Anesthesia, sponsored by Nazmy Edward Seif. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-12.

Sponsored by Nazmy Edward Seif · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Continuous spinal anesthesia
  • General anesthesia
  • Renal transplantation
  • Chronic renal failure
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Any condition contra-indicating regional anesthesia
  • Coagulopathy
  • Allergic to any of the drugs used during the procedure
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    CSA group

    Continuous Spinal Anesthesia

    Procedure: Continuous spinal anesthesia

  • Active comparator
    GA group

    General Anesthesia

    Procedure: General anesthesia

Interventions

  • ProcedureContinuous 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.

  • ProcedureGeneral 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.

05

What researchers measure

Primary outcomes

  1. Mean ABP

    Change in Mean Arterial Blood Pressure measured in mmHg.

    Time frame: 12 hours

Secondary outcomes

  1. 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 \[where 0=no pain, 10= worst pain\].

    Time frame: 12 hours

  2. 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).

    Time frame: 24 hours

06

Study locations

1 site
  • Kasr Al-Ainy Hospital, Cairo University
    Cairo, Egypt
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03436368
Lead sponsor
Nazmy Edward Seif
Responsible party
Nazmy Edward Seif (Clinical Professor, Cairo University) — Sponsor-investigator
First posted
Feb 19, 2018
Start date
Feb 20, 2018
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jan 12, 2026

Study contacts

Nazmy E Seif, MD
study chair · Kasr Al-Ainy Hospital, Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion