Awake Thoracic Epidural Anaesthesia Versus General Anesthesia for Video Assisted Thoracoscopic Surgery

NCT ID: NCT03902470

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2021-07-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thoracic epidural anaesthesia for vats

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.

Group Type: EXPERIMENTAL

Thoracic epidural anaesthesia video assisted thoracoscopic surgery

Intervention Type: PROCEDURE

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%.

General anesthesia for vats

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.

Group Type: ACTIVE_COMPARATOR

Thoracic epidural anaesthesia video assisted thoracoscopic surgery

Intervention Type: PROCEDURE

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%.

Interventions

Thoracic epidural anaesthesia video assisted thoracoscopic 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%.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

rabeea ahmed Mohamed

Resident at assiut university hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mohamed Rabeea Ahmed

Role: CONTACT

docmedo91@gmail.com

01024475093 ext. 01129203464

Other Identifiers

Anesthesia for VATS

Identifier Type: -

Identifier Source: org_study_id