Awake Thoracic Epidural Anesthesia Versus General Anesthesia in Thoracotomy

NCT06930183 | Recruiting

• 1 other identifier: AP2411-501-086-193
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare awake thoracic epidural anesthesia and general anesthesia in thoracotomy.

Conditions

Awake; Thoracic Epidural Anesthesia; General Anesthesia; Thoracotomy

Outcome Measures

Primary Outcomes (1)

• Assessment the change in pulmonary function

  The change in pulmonary function will be assessed using Forced vital capacity (FVC) will be recorded.

  24 hours postoperatively

Secondary Outcomes (6)

• Heart rate

  Till the end of surgery (Up to 2 hours)

• Mean arterial pressure

  Till the end of surgery (Up to 2 hours)

• Degree of pain

  48 hours postoperatively

• Total morphine consumption

  48 hours postoperatively

• Time to 1st rescue analgesia

  48 hours postoperatively

Study Arms (2)

Awake thoracic epidural anesthesia group

EXPERIMENTAL

Patients will preoperatively receive awake thoracic epidural anesthesia.

Drug: Awake thoracic epidural anesthesia

General anesthesia group

ACTIVE COMPARATOR

Patients will receive general anesthesia.

Drug: General anesthesia

Interventions

Awake thoracic epidural anesthesia DRUG

Patients will preoperatively receive awake thoracic epidural anesthesia.

Also known as: Bupivacaine

Awake thoracic epidural anesthesia group

General anesthesia DRUG

Patients will receive general anesthesia.

Also known as: Fentanyl

General anesthesia group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 75 years old.
• Both genders.
• American Society of Anesthesiologists (ASA) physical status classification II or III.
• Scheduled for thoracotomy.

You may not qualify if:

• Difficult airway management,
• Hemodynamically unstable patients, obesity (body mass index \>30).
• Absolute contraindication to thoracic epidural anesthesia such as (patient refusal, allergy to local anesthetics, coagulopathy, active neurologic disorders, skin infection at insertion site, uncooperative patients, uncontrolled cough, and unfavorable anatomy for thoracic epidural).
• Neurological disorders: risk of seizure, unable to cooperate, intracranial mass or brain edema, extensive pleural adhesions or previous pulmonary resections, hypoxemia (PaO2 \<60) or hypercarbia (PaCO2 \>50)
• Poor cardiac function (ejection fraction less than 50%).
• Patients with bad pulmonary function tests.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

RECRUITING

MeSH Terms

Interventions

Bupivacaine; Anesthesia, General; Fentanyl

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthesia; Anesthesia and Analgesia; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Mohamed E Abdel Fattah, MD

CONTACT

00201284475792; mohamed-elsaid@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Surgical ICU and Pain Management, Faculty of Medicine, National Cancer Institute, Cairo University, Egypt.

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 16, 2025
• Study Start: April 16, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)