Renal Failure ChronicNCT03436368
Continuous Spinal Anesthesia in Renal Transplantation
A study testing Continuous spinal anesthesia and General anesthesia in people with Renal Failure Chronic and Transplant;Failure,Kidney, run by Nazmy Edward Seif at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Failure Chronic, Transplant;Failure,Kidney, Anesthesia
- What is being tested?
- Continuous spinal anesthesia and General anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2018to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA class III or IV
- End-stage renal disease
- Renal transplantation candidate patients
Who cannot join
- Any condition contra-indicating regional anesthesia
- Coagulopathy
- Allergic to any of the drugs used during the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Spinal Anesthesia for Renal Transplant Recipients
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
- Being tested
- Continuous spinal anesthesia, General anesthesia
- Keywords
- Continuous spinal anesthesia, General anesthesia, Renal transplantation, Chronic renal failure
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous spinal anesthesiaProcedure or surgery
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 anesthesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| CSA group | Active comparator | Continuous Spinal Anesthesia Receives: Procedure: Continuous spinal anesthesia |
| GA group | Active comparator | General Anesthesia Receives: Procedure: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean ABP
Change in Mean Arterial Blood Pressure measured in mmHg.
Measured: 12 hours
Secondary outcomes (2)
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].
Measured: 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).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start20 Feb 2018
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Failure ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nazmy Edward Seif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nazmy Edward Seif, Cairo University
- Investigators
- Nazmy E Seif, MD, Study chair, Kasr Al-Ainy Hospital, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436368
- Sponsor's protocol ID
- CSARTR60
- Status last verified
- Jan 2026
- First submitted
- 12 Feb 2018
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Spinal Anesthesia for Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT03436368
- Acronym / sponsor ID
- CSARTR60
- Conditions
- Renal Failure Chronic, Transplant;Failure,Kidney, Anesthesia
- Keywords
- Continuous spinal anesthesia, General anesthesia, Renal transplantation, Chronic renal failure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nazmy Edward SeifUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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]
| Arm | Type | Receives |
|---|---|---|
| CSA group | Active comparator | Procedure: Continuous spinal anesthesiaContinuous Spinal Anesthesia |
| GA group | Active comparator | Procedure: General anesthesiaGeneral Anesthesia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA class III or IV
- End-stage renal disease
- Renal transplantation candidate patients
Key exclusion criteria (3 listed)
- Any condition contra-indicating regional anesthesia
- Coagulopathy
- Allergic to any of the drugs used during the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous spinal anesthesiaContinuous 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. | Procedure or surgery | CSA group |
| General anesthesiaAnesthesia 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. | Procedure or surgery | GA group |
Primary outcome
Mean ABP
Time frame: 12 hours
Change in Mean Arterial Blood Pressure measured in mmHg.
2 secondary outcomes
Visual Analogue Score for pain "VAS"
Time frame: 12 hours
Patient satisfaction score
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazmy E Seif, MD study chair
Kasr Al-Ainy Hospital, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous spinal anesthesia and General anesthesia in people with Renal Failure Chronic and Transplant;Failure,Kidney, run by Nazmy Edward Seif at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean ABP (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.