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Continuous Spinal Anesthesia in Renal Transplantation

Primary Purpose

Renal Failure Chronic, Transplant;Failure,Kidney, Anesthesia

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Continuous spinal anesthesia
General anesthesia
Sponsored by
Nazmy Edward Seif
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Renal Failure Chronic focused on measuring Continuous spinal anesthesia, General anesthesia, Renal transplantation, Chronic renal failure

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kasr Al-Ainy Hospital, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CSA group

GA group

Arm Description

Continuous Spinal Anesthesia

General Anesthesia

Outcomes

Primary Outcome Measures

Mean ABP
Change in Mean Arterial Blood Pressure measured in mmHg.

Secondary Outcome Measures

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].
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).

Full Information

First Posted
February 12, 2018
Last Updated
February 7, 2023
Sponsor
Nazmy Edward Seif
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1. Study Identification

Unique Protocol Identification Number
NCT03436368
Brief Title
Continuous Spinal Anesthesia in Renal Transplantation
Official Title
Continuous Spinal Anesthesia for Renal Transplant Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 20, 2018 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nazmy Edward Seif

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure Chronic, Transplant;Failure,Kidney, Anesthesia
Keywords
Continuous spinal anesthesia, General anesthesia, Renal transplantation, Chronic renal failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CSA group
Arm Type
Active Comparator
Arm Description
Continuous Spinal Anesthesia
Arm Title
GA group
Arm Type
Active Comparator
Arm Description
General Anesthesia
Intervention Type
Procedure
Intervention Name(s)
Continuous spinal anesthesia
Intervention Description
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
Intervention Name(s)
General anesthesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean ABP
Description
Change in Mean Arterial Blood Pressure measured in mmHg.
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Visual Analogue Score for pain "VAS"
Description
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
Title
Patient satisfaction score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazmy E Seif, MD
Organizational Affiliation
Kasr Al-Ainy Hospital, Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Kasr Al-Ainy Hospital, Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Continuous Spinal Anesthesia in Renal Transplantation

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