Clinical trial NCT03902470: Awake Thoracic Epidural Anaesthesia Versus General Anesthesia for Video Assisted Thoracoscopic Surgery
Official title: Comparative Study Between Awake Thoracic Epidural Anaesthesia and General Anesthesia for Video Assisted Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Lung Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Recovery time after intervention of each group
timeFrame: 7days
Secondary outcomes:
measure: Patient agitation and sedation by using richmond agitation-sedation scale(RASS)
timeFrame: 4 hourly postoperative.
Other outcomes:
measure: Incidence of complications
timeFrame: 14days
Locations:
Study officials:
References: