ClinicalTrials.gg
RecruitingNCT04546230Updated Jan 12, 2026

Low-Thoracic Epidural Anesthesia For Laparoscopic Nephrectomy.

An interventional study of Low-Thoracic Epidural Anesthesia and General Anesthesia in Laparoscopic, Nephrectomy and Anesthesia, sponsored by Nazmy Edward Seif. 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

From the registry’s dates

  • Started Sep 2020; still recruiting 6 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

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.

02

Conditions studied

  • Laparoscopic
  • Nephrectomy
  • Anesthesia
  • Epidural

Keywords

  • Epidural Anesthesia
  • Low-thoracic
  • Laparoscopic nephrectomy
03

In context

Lead sponsor

Nazmy Edward Seif is the lead sponsor of 14 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • .
  • Adult patients scheduled for laparoscopic nephrectomy.

Exclusion criteria

Exclusion Criteria:

  • Patient refusal.
  • to regional anesthesia (e.g., coagulopathy, site infection).
  • Allergy to local anesthetics.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

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

Study arms

  • Experimental
    E group

    Low-Thoracic Epidural Anesthesia

    Procedure: Low-Thoracic Epidural Anesthesia

  • Active comparator
    G group

    General Anesthesia

    Procedure: General Anesthesia

Interventions

  • ProcedureLow-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.

  • ProcedureGeneral 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.

06

What researchers measure

Primary outcomes

  1. Overall patient satisfaction.

    The overall degree of patients' satisfaction will be assessed using a "5-point patient satisfaction rating scale" according to Likert scale \[where: very unsatisfied=1/5, unsatisfied=2/5, neutral=3/5, satisfied=4/5, and very satisfied=5/5\].

    Time frame: 24 hours

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2020 (actual). Primary completion is estimated for Dec 2026, 75 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 6, 2020
First posted
Sep 11, 2020
StartActual
Sep 19, 2020
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Jan 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04546230
Lead sponsor
Nazmy Edward Seif
Responsible party
Nazmy Edward Seif (Clinical Professor, Cairo University) — Sponsor-investigator
First posted
Sep 11, 2020
Start date
Sep 19, 2020
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jan 12, 2026

Study contacts

Nazmy S Michael, MD
Contact
nazmy.seif@gmail.com
01227400808 ext. +2
Atef K Salama, MD
Contact
atef.kamel@kasralainy.edu.eg
01001155851 ext. +2
Nazmy S Michael, MD
principal investigator · Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
Atef K Salama, MD
study director · Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

Oversight

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

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