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

NCT03902470 | Unknown Phase 1

• 1 other identifier: Anesthesia for VATS
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient agitation and sedation by using richmond agitation-sedation scale(RASS)

  4 hourly postoperative.

Other Outcomes (1)

• Incidence of complications

  14days

Study Arms (2)

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.

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.

Procedure: Thoracic epidural anaesthesia video assisted thoracoscopic surgery

Interventions

Thoracic epidural anaesthesia video assisted thoracoscopic surgery 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; Thoracic epidural anaesthesia for vats

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Mohamed Rabeea Ahmed

CONTACT

01024475093; docmedo91@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at assiut university hospital

Model Details: 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.

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: April 4, 2019
• Study Start: May 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: July 1, 2021
• Last Updated: April 4, 2019

Record last verified: 2019-04