AwakeNCT06930183
Awake Thoracic Epidural Anesthesia Versus General Anesthesia in Thoracotomy
A study testing Awake thoracic epidural anesthesia and General anesthesia in people with Awake and Thoracic Epidural Anesthesia, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to compare awake thoracic epidural anesthesia and general anesthesia in thoracotomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Awake, Thoracic Epidural Anesthesia, General Anesthesia
- What is being tested?
- Awake thoracic epidural anesthesia and General anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Apr 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 75 years old.
- Both genders.
- American Society of Anesthesiologists (ASA) physical status classification II or III.
- Scheduled for thoracotomy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 12613
Mohamed E Abdel Fattah, MD, 00201284475792, mohamed-elsaid@cu.edu.eg
Samuel F Samy, MD
About this study
Official title: Awake Thoracic Epidural Anesthesia Versus General Anesthesia in Thoracotomy: A Randomized Controlled Trial
This study aims to compare awake thoracic epidural anesthesia and general anesthesia in thoracotomy.
Read the 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
- Conditions
- Awake, Thoracic Epidural Anesthesia, General Anesthesia, Thoracotomy
- Being tested
- Awake thoracic epidural anesthesia, General anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awake thoracic epidural anesthesiaDrug
Also called Bupivacaine
Patients will preoperatively receive awake thoracic epidural anesthesia.
General anesthesiaDrug
Also called Fentanyl
Patients will receive general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Awake thoracic epidural anesthesia group | Experimental | Patients will preoperatively receive awake thoracic epidural anesthesia. Receives: Drug: Awake thoracic epidural anesthesia |
| General anesthesia group | Active comparator | Patients will receive general anesthesia. Receives: Drug: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment the change in pulmonary function
The change in pulmonary function will be assessed using Forced vital capacity (FVC) will be recorded.
Measured: 24 hours postoperatively
Secondary outcomes (6)
Heart rate
Heart rate will be recorded at baseline, and every 15min till the end of surgery.
Measured: Till the end of surgery (Up to 2 hours)
Mean arterial pressure
Mean arterial pressure will be recorded at baseline, and every 15min till the end of surgery.
Measured: Till the end of surgery (Up to 2 hours)
Degree of pain
The patients will be instructed how to report pain by means of the visual analogue scale (VAS), in which 0 = "no pain" and 10 = "worst possible pain". VAS will be assessed at post-anesthesia care unit (PACU), 1, 2, 4, 8, 12,18, 24, 36, 48 hours postoperative.
Measured: 48 hours postoperatively
Total morphine consumption
Rescue analgesia of morphine will be given as 3 mg bolus if the VAS > 3 to be repeated after 30 min if pain persists until the visual analogue scale (VAS) < 4.
Measured: 48 hours postoperatively
Time to 1st rescue analgesia
Time to 1st rescue analgesia (time from end of surgery to first dose of morphine administrated).
Measured: 48 hours postoperatively
Incidence of adverse events
Incidence of adverse events such as nausea, vomiting, and respiratory depression will be recorded.
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start16 Apr 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AwakeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elsaid Abdel Fattah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930183
- Sponsor's protocol ID
- AP2411-501-086-193
- Status last verified
- Apr 2025
- First submitted
- 28 Mar 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awake Thoracic Epidural Anesthesia Versus General Anesthesia in Thoracotomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06930183
- Acronym / sponsor ID
- AP2411-501-086-193
- Conditions
- Awake, Thoracic Epidural Anesthesia, General Anesthesia, Thoracotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Awake thoracic epidural anesthesia group | Experimental | Drug: Awake thoracic epidural anesthesiaPatients will preoperatively receive awake thoracic epidural anesthesia. |
| General anesthesia group | Active comparator | Drug: General anesthesiaPatients will receive general anesthesia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18 to 75 years old.
- Both genders.
- American Society of Anesthesiologists (ASA) physical status classification II or III.
- Scheduled for thoracotomy.
Key exclusion criteria (6 listed)
- 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%).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Awake thoracic epidural anesthesiaAlso: BupivacainePatients will preoperatively receive awake thoracic epidural anesthesia. | Drug | Awake thoracic epidural anesthesia group |
| General anesthesiaAlso: FentanylPatients will receive general anesthesia. | Drug | General anesthesia group |
Primary outcome
Assessment the change in pulmonary function
Time frame: 24 hours postoperatively
The change in pulmonary function will be assessed using Forced vital capacity (FVC) will be recorded.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Awake thoracic epidural anesthesia and General anesthesia in people with Awake and Thoracic Epidural Anesthesia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed E Abdel Fattah, MD (00201284475792, mohamed-elsaid@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment the change in pulmonary function (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.