Awake Thoracic Epidural Anesthesia Versus General Anesthesia in Thoracotomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Awake thoracic epidural anesthesia, General anesthesia.
- Who it may be relevant to
- Registry conditions: Awake, Thoracic Epidural Anesthesia, General Anesthesia, Thoracotomy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Awake Thoracic Epidural Anesthesia Versus General Anesthesia in Thoracotomy: A Randomized Controlled Trial
Overview
This study aims to compare awake thoracic epidural anesthesia and general anesthesia in thoracotomy.
Detailed description
The severity of acute postoperative pain is a causative factor for chronic postsurgical pain, and it has been observed that the incidence of chronic postsurgical pain is very high after thoracotomy. Effective management of acute post-operative pain is a must in these patients.
Thoracic epidural analgesia (TEA) is used as an adjunct to general anesthesia (GA) in thoracic surgery. However, tthe horacic epidural blockade has been rarely utilized as a sole method to provide anesthesia for major thoracic procedures
Interventions
- Drug Awake thoracic epidural anesthesia
Patients will preoperatively receive awake thoracic epidural anesthesia. - Drug General anesthesia
Patients will receive general anesthesia.
Primary outcome measures
- Assessment the change in pulmonary function [Time frame: 24 hours postoperatively]
Secondary outcome measures (6)
- Heart rate [Time frame: Till the end of surgery (Up to 2 hours)]
- Mean arterial pressure [Time frame: Till the end of surgery (Up to 2 hours)]
- Degree of pain [Time frame: 48 hours postoperatively]
- Total morphine consumption [Time frame: 48 hours postoperatively]
- Time to 1st rescue analgesia [Time frame: 48 hours postoperatively]
- Incidence of adverse events [Time frame: 48 hours postoperatively]
Eligibility criteria
Inclusion criteria
- Age from 18 to 75 years old.
- Both genders.
- American Society of Anesthesiologists (ASA) physical status classification II or III.
- Scheduled for thoracotomy.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Cairo University — Cairo
Identifiers
NCT: NCT06930183 · AP2411-501-086-193