Low-Thoracic Epidural Anesthesia For Laparoscopic Nephrectomy.

Sponsor

Nazmy Edward Seif (Other)

Overall Status

Recruiting

CT.gov ID

NCT04546230

Collaborator

(none)

Enrollment

Location

Arms

27.4

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Laparoscopic Nephrectomy Anesthesia Epidural	Procedure: Low-Thoracic Epidural Anesthesia Procedure: General Anesthesia	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Sep 19, 2020

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: E group Low-Thoracic Epidural Anesthesia	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.
Active Comparator: G group General Anesthesia	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.

Arm

Intervention/Treatment

Experimental: E group

Low-Thoracic Epidural Anesthesia

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.

Active Comparator: G group

General Anesthesia

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.

Outcome Measures

Primary Outcome Measures

Overall patient satisfaction. [24 hours]
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].

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University Hospitals	Cairo		Egypt

Sponsors and Collaborators

Nazmy Edward Seif

Investigators

Principal Investigator: Nazmy S Michael, MD, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
Study Director: Atef K Salama, MD, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nazmy Edward Seif, Clinical Professor, Cairo University

ClinicalTrials.gov Identifier:

NCT04546230

Other Study ID Numbers:

LTEALN

First Posted:

Sep 11, 2020

Last Update Posted:

Jul 20, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nazmy Edward Seif, Clinical Professor, Cairo University

Epidural Anesthesia

Low-thoracic

Laparoscopic nephrectomy

Additional relevant MeSH terms:

Anesthetics

Study Results

No Results Posted as of Jul 20, 2022