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Low-Thoracic Epidural Anesthesia For Laparoscopic Nephrectomy.

NCT04546230 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-01-12

No results posted yet for this study

Summary

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.

Conditions

  • Laparoscopic
  • Nephrectomy
  • Anesthesia
  • Epidural

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 a continuous infusion to be started 1 hour later \& continued throughout the procedure.

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.

Sponsors & Collaborators

  • Nazmy Edward Seif

    lead OTHER

Principal Investigators

  • Nazmy S Michael, MD · Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

  • Atef K Salama, MD · Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-19
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04546230 on ClinicalTrials.gov