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Recruiting NCT04546230

Low-Thoracic Epidural Anesthesia For Laparoscopic Nephrectomy.

No phase Interventional Laparoscopic Nephrectomy Anesthesia Epidural

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low-Thoracic Epidural Anesthesia, General Anesthesia.
Who it may be relevant to
Registry conditions: Laparoscopic, Nephrectomy, Anesthesia, Epidural. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Low-Thoracic Epidural Anesthesia For Laparoscopic Nephrectomy In Adult Patients.

Overview

Laparoscopic nephrectomy is a surgical technique to excise a diseased kidney. It's a minimally invasive technique, so when compared to open surgery, it can mean significantly less post-operative pain, shorter hospital stay, earlier return to work and daily life activities, a more favourable cosmetic result and outcomes similar to that of open surgery. Recently, advanced laparoscopic surgery has targeted older and high risk patients for general anesthesia; in these patients, regional anesthesia offers several advantages with improved patient satisfaction. Compared with alternative anesthetic techniques, epidural anesthesia may reduce the risks of venous thromboembolism, myocardial infarction, bleeding complications, pneumonia, respiratory depression and renal failure. The aim of this study is to compare the conventional general anesthetic technique to the regional anesthesia for laparoscopic nephrectomy, in modified lateral decubitus position using low-pressure pneumoperitoneum.

Interventions

  • Procedure Low-Thoracic Epidural Anesthesia
    Under aseptic conditions and local anesthesia, an epidural catheter will be inserted using the "Prefix Epidural Anesthesia Tray" with an 18 G Tuohy needle \& a 20 G catheter at the T7-8 or T8-9 intervertebral space. The epidural catheter will be threaded leaving 3 cm within the epidural space and tapped in place. Using a mixed preparation of isobaric Bupivacaine 0.5% with Fentanyl 2 μg per ml volume, a bolus dose of 5-10 ml will then be given via the epidural catheter, followed by 5-10 ml/hr as
  • Procedure General Anesthesia
    General anaesthesia will be induced with intra-venous administration of Fentanyl (2 μg/kg), Propofol (2 mg/kg), Atracurium (0.5 mg/kg) and Lidocaine (1 mg/kg). After tracheal intubation, balanced anaesthesia will be maintained with isoflurane in oxygen \& infusion of atracurium at a rate of 0.5 mg/kg/hr; and mechanical ventilation will be provided.

Primary outcome measures

  • Overall patient satisfaction. [Time frame: 24 hours]

Eligibility criteria

Inclusion criteria

  • ASA I - II.
  • Adult patients scheduled for laparoscopic nephrectomy.

Exclusion criteria

  • Patient refusal.
  • Contraindication to regional anesthesia (e.g., coagulopathy, site infection).
  • Allergy to local anesthetics.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Egypt · 1 center
  • Cairo University Hospitals — Cairo

Identifiers

NCT: NCT04546230 · LTEALN

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗