Low-Thoracic Epidural Anesthesia For Laparoscopic Nephrectomy.

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

Sponsors

Lead Sponsor: Nazmy Edward Seif

Source Cairo University
Brief 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.

Overall Status Recruiting
Start Date September 19, 2020
Completion Date March 2021
Primary Completion Date March 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Overall patient satisfaction. 24 hours
Enrollment 80
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Low-Thoracic Epidural Anesthesia

Description: 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.

Arm Group Label: E group

Intervention Type: Procedure

Intervention Name: General Anesthesia

Description: 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.

Arm Group Label: G group

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Nazmy S Michael, MD

Phone: 01227400808

Phone Ext.: +2

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Cairo University Hospitals Nazmy S Michael, MD 01227400808 +2 [email protected]
Location Countries

Egypt

Verification Date

September 2020

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Cairo University

Investigator Full Name: Nazmy Edward Seif

Investigator Title: Clinical Professor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: E group

Type: Experimental

Description: Low-Thoracic Epidural Anesthesia

Label: G group

Type: Active Comparator

Description: General Anesthesia

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov