Lung CancerPhase 1NCT03902470
Awake Thoracic Epidural Anaesthesia Versus General Anesthesia for Video Assisted Thoracoscopic Surgery
A Phase 1 study testing Thoracic epidural anaesthesia video assisted thoracoscopic surgery in people with Lung Cancer, run by Assiut University.
Trial summary
Thoracic procedures are routinely performed under general anesthesia (GA), with one lung ventilation (OLV)by double lumen tube or (GA) in spontaneously breathing patient by TIVA or LMA are usually combined with thoracic epidural analgesia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Thoracic epidural anaesthesia video assisted thoracoscopic surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2019to Jul 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range between 18 and 60 years.
- ASA score equal to or less than III.
- The absence of severe emphysema or clinical signs of active infectious disease.
- The procedure is predicted to be completed within two hours.
Who cannot join
- Patients with expected difficult airway management
- Haemodynamically unstable patients
- Obesity (body mass index >30)
- Inexperienced and poorly cooperative surgical team
- Coagulopathy (international normalized ratio >1.5)
- Persistent cough or high airway secretion
Show all 10Show fewer
- Neurological disorders: risk of seizure, unable to cooperate, intracranial mass or brain oedema
- Extensive pleural adhesions or previous pulmonary resections
- Hypoxaemia (PaO2 <60) or hypercarbia (PCO2 >50)
- Any contraindications for use of regional anesthesia technique
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study Between Awake Thoracic Epidural Anaesthesia and General Anesthesia for Video Assisted Thoracoscopic Surgery
Thoracic procedures are routinely performed under general anesthesia (GA), with one lung ventilation (OLV)by double lumen tube or (GA) in spontaneously breathing patient by TIVA or LMA are usually combined with thoracic epidural analgesia.
However, GA whether mechanically ventilated or spontaneously breathing may have adverse effects including peri-intubation hypoxia, trauma to the upper airway, mechanical ventilation-induced injuries, impaired cardiac performance, neuromuscular problems in OLV and increased risk of pneumonia, and release of proinflammatory mediators in generally.
Read more
Recently, awake thoracic epidural anesthesia (ATEA) has been used alone in thoracic procedures The results achieved in early studies have been encouraging. ATEA may eventually provide an alternative method to GA for thoracic procedures that would not only eliminate the need for GA but also facilitate both surgical reconstruction and eventually patient recovery.
Recent studies suggested better clinical outcomes with ATEA, including less intraoperative bleeding, a better control of postoperative pain, early mobilization and short hospital stay, oral intake tolerance, reduction of surgical stress response, reduction of intraoperative cardiac events, improvement of myocardial flow determinants and left ventricular function, and a reduction of complications including pulmonary, thrombotic and infectious events.
- Conditions
- Lung Cancer
- Being tested
- Thoracic epidural anaesthesia video assisted thoracoscopic surgery
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic epidural anaesthesia video assisted thoracoscopic surgeryProcedure or surgery
Patients in (TEA) group will pre-medicated using midazolam 3-4 mg (IV)and fentanyl 50 mcg (IV). Then An epidural catheter will be inserted between T3-T4 and T4-T5 . A test dose (5 ml) of 2% lidocaine will be given, followed by 15-20 ml of bupivacain 0.5%.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic epidural anaesthesia for vats | Experimental | Patients in thoracic epidural (TE) group will pre-medicated using midazolam 3-4 mg intravenous (IV)and fentanyl 50 mcg intravenously(i.v.). Then patients will placed in the lateral decubitus position. An epidural catheter will be inserted between T3-T4 and T4-T5 for all thoracic procedures except sympathectomy and thymectomy. A test dose (5 ml) of 2% lidocaine will be given, followed by 15-20 ml of bupivacain 0.5% and 50 mcg of fentanyl.
The objective is to achieve sensory and motor block between C7 and T7 levels. At this level diaphragmatic respiration is maintained. The anaesthesia level will be monitored by warm-cold discrimination. Receives: Procedure: Thoracic epidural anaesthesia video assisted thoracoscopic surgery |
| General anesthesia for vats | Active comparator | Patients will receive general anesthesia as follows, Premedication in the form of 3-4 mg midazolam (IV), induction of a anesthesia with propofol (2mg/kg) and fentanyl (1 mcg/kg). Tracheal intubation and double endotracheal tube insertion will be facilitated with cisatracurium 0.1 mg/kg. and confirmation of it is position will made by fiberoptic bronchoscopy, Anesthesia will be maintained with isoflurane (1-2 %) and cisatracurium (0.05 mg/kg per dose).After the end of the operation, anesthesia will be discontinued, the wound dressing will be applied, and extubation of the patient will be done after reversal of muscle relaxant by neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg) and extubation will be performed after complete neuromuscular recovery. Receives: Procedure: Thoracic epidural anaesthesia video assisted thoracoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time after intervention of each group
The time of anesthesia recovery, resumption of oral intake,and the length of hospital stay,postoperative recovery index will be used will be used to assess recovery as next Higher scores reflect greater difficulty in post-operative recovery
No Difficulty 1 Little Difficulty >1 to <1.5 Moderate Difficulty 1.5 to <2.5 Considerable Difficulty 2.5 to <3.5 Extreme Difficulty 3.5 to 5 PoRI Scale and Subscale Scoring System.
Measured: 7days
Secondary outcomes (1)
Patient agitation and sedation by using richmond agitation-sedation scale(RASS)
- Observe patient
- Patient is alert, restless, or agitated. (Score 0 to +4) 2. If not alert, state patient's name and say to open eyes and look at speaker.
- Patient awakens with sustained eye opening and eye contact. (Score -1)
- Patient awakens with eye opening and eye contact, but not sustained. (Score -2)
- Patient has any movement in response to voice but no eye contact. (Score -3) 3. When no response to verbal stimulation, physically stimulate patient by shaking shoulder and/or rubbing sternum.
- Patient has any movement to physical stimulation. (Score -4)
- Patient has no response to any stimulation. (Score -5)
Measured: 4 hourly postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start1 May 2019 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Assiut 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In determining a significant difference (20%) in the occurrence of postoperative pain score by using the power of 80% and a significance level of 5% and this will result in 30 patients in each group.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rabeea ahmed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902470
- Sponsor's protocol ID
- Anesthesia for VATS
- Status last verified
- Apr 2019
- First submitted
- 21 Mar 2019
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Awake Thoracic Epidural Anaesthesia and General Anesthesia for Video Assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT03902470
- Acronym / sponsor ID
- Anesthesia for VATS
- Conditions
- Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 4 Apr 2019 (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.
Thoracic procedures are routinely performed under general anesthesia (GA), with one lung ventilation (OLV)by double lumen tube or (GA) in spontaneously breathing patient by TIVA or LMA are usually combined with thoracic epidural analgesia.
However, GA whether mechanically ventilated or spontaneously breathing may have adverse effects including peri-intubation hypoxia, trauma to the upper airway, mechanical ventilation-induced injuries, impaired cardiac performance, neuromuscular problems in OLV and increased risk of pneumonia, and release of proinflammatory mediators in generally.
Recently, awake thoracic epidural anesthesia (ATEA) has been used alone in thoracic procedures The results achieved in early studies have been encouraging. ATEA may eventually provide an alternative method to GA for thoracic procedures that would not only eliminate the need for GA but also facilitate both surgical reconstruction and eventually patient recovery.
Recent studies suggested better clinical outcomes with ATEA, including less intraoperative bleeding, a better control of postoperative pain, early mobilization and short hospital stay, oral intake tolerance, reduction of surgical stress response, reduction of intraoperative cardiac events, improvement of myocardial flow determinants and left ventricular function, and a reduction of complications including pulmonary, thrombotic and infectious events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In determining a significant difference (20%) in the occurrence of postoperative pain score by using the power of 80% and a significance level of 5% and this will result in 30 patients in each group.
| Arm | Type | Receives |
|---|---|---|
| Thoracic epidural anaesthesia for vats | Experimental | Procedure: Thoracic epidural anaesthesia video assisted thoracoscopic surgeryPatients in thoracic epidural (TE) group will pre-medicated using midazolam 3-4 mg intravenous (IV)and fentanyl 50 mcg intravenously(i.v.). Then patients will placed in the lateral decubitus position. An epidural catheter will be inserted between T3-T4 and T4-T5 for all thoracic procedures except sympathectomy and thymectomy. A test dose (5 ml) of 2% lidocaine will be given, followed by 15-20 ml of bupivacain 0.5% and 50 mcg of fentanyl. The objective is to achieve sensory and motor block between C7 and T7 levels. At this level diaphragmatic respiration is maintained. The anaesthesia level will be monitored by warm-cold discrimination. |
| General anesthesia for vats | Active comparator | Procedure: Thoracic epidural anaesthesia video assisted thoracoscopic surgeryPatients will receive general anesthesia as follows, Premedication in the form of 3-4 mg midazolam (IV), induction of a anesthesia with propofol (2mg/kg) and fentanyl (1 mcg/kg). Tracheal intubation and double endotracheal tube insertion will be facilitated with cisatracurium 0.1 mg/kg. and confirmation of it is position will made by fiberoptic bronchoscopy, Anesthesia will be maintained with isoflurane (1-2 %) and cisatracurium (0.05 mg/kg per dose).After the end of the operation, anesthesia will be discontinued, the wound dressing will be applied, and extubation of the patient will be done after reversal of muscle relaxant by neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg) and extubation will be performed after complete neuromuscular recovery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age range between 18 and 60 years.
- ASA score equal to or less than III.
- The absence of severe emphysema or clinical signs of active infectious disease.
- The procedure is predicted to be completed within two hours.
Key exclusion criteria (10 listed)
- Patients with expected difficult airway management
- Haemodynamically unstable patients
- Obesity (body mass index >30)
- Inexperienced and poorly cooperative surgical team
- Coagulopathy (international normalized ratio >1.5)
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 |
|---|---|---|
| Thoracic epidural anaesthesia video assisted thoracoscopic surgeryPatients in (TEA) group will pre-medicated using midazolam 3-4 mg (IV)and fentanyl 50 mcg (IV). Then An epidural catheter will be inserted between T3-T4 and T4-T5 . A test dose (5 ml) of 2% lidocaine will be given, followed by 15-20 ml of bupivacain 0.5%. | Procedure or surgery | General anesthesia for vats, Thoracic epidural anaesthesia for vats |
Primary outcome
Recovery time after intervention of each group
Time frame: 7days
The time of anesthesia recovery, resumption of oral intake,and the length of hospital stay,postoperative recovery index will be used will be used to assess recovery as next Higher scores reflect greater difficulty in post-operative recovery No Difficulty 1 Little Difficulty >1 to <1.5 Moderate Difficulty 1.5 to <2.5 Considerable Difficulty 2.5 to <3.5 Extreme Difficulty 3.5 to 5 PoRI Scale and Subscale Scoring System.
1 secondary outcome
Patient agitation and sedation by using richmond agitation-sedation scale(RASS)
Time frame: 4 hourly postoperative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Thoracic epidural anaesthesia video assisted thoracoscopic surgery in people with Lung Cancer, run by Assiut University.
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 10 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: status not confirmed, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Rabeea Ahmed (01024475093 ext. 01129203464, docmedo91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery time after intervention of each group (time frame: 7days). 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 4 Apr 2019.