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

Lung Cancer Clinical Trial

Official title:

Comparative Study Between Awake Thoracic Epidural Anaesthesia and General Anesthesia for Video Assisted Thoracoscopic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03902470
• Other study ID #: Anesthesia for VATS
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 1, 2019
• Est. completion date: July 2021

Study information

• Verified date: April 2019
• Source: Assiut University
• Contact: Mohamed Rabeea Ahmed
• Phone: 01024475093
• Email: docmedo91[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Procedure:
• 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%.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of complications	Impaired cardiac performance assessed by Echo and incidence of pneumonia assessed by chest x-ray.	14days
Primary	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.	7days
Secondary	Patient agitation and sedation by using richmond agitation-sedation scale(RASS)	1. 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)	4 hourly postoperative.