Low-Thoracic Epidural Anesthesia For Laparoscopic Nephrectomy.

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04546230
• Other study ID #: LTEALN
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2020
• Est. completion date: July 2024

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: Nazmy S Michael, MD
• Phone: 01227400808
• Email: nazmy.seif[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Epidural
• Laparoscopic
• Nephrectomy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Cairo University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Nazmy Edward Seif

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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].	24 hours