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

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.

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 Overview

• Status: Unknown
• Conditions: Lung Cancer
• Intervention / Treatment: Procedure: Thoracic epidural anaesthesia video assisted thoracoscopic surgery

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Mohamed Rabeea Ahmed; Phone Number: 01129203464 01024475093; Email: docmedo91@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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%.
Active Comparator: 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.	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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of complications	Impaired cardiac performance assessed by Echo and incidence of pneumonia assessed by chest x-ray.	14days

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2019
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Anesthesia for VATS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No