A Comparative Study Between Regional Anesthesia in Thoracoscopes and the Conventional General Anesthesia

Mohamed Reda Ashour40 enrolled

Overview

Video-assisted thoracic surgery (VATS) is usually performed with general anesthesia and single lung ventilation. However, performing thoracic surgery under awake regional anesthesia has several potential advantages including avoidance of airway trauma and ventilator dependence associated with endotracheal intubation, besides promoting enhanced recovery after surgery and shorter mean hospital stay.

The aim of this study is to investigate the feasibility and the effect of Thoracic Epidural Anaesthesia for awake thoracic surgery to speed up recovery in patients as well as avoiding the complications accompanying General Anesthesia with one lung ventilation. Type of Study: Prospective randomized clinical study. Study Setting: This study will be conducted in Ain Shams University Hospitals.. Study Period: Expected for two years starting from 2019. Sampling Method: Randomized sampling by a computer generated random numbers table. Sample Size: 40 patients. Sample size was calculated using PASS 11 program for sample size calculation and according to the (Pompeo et al., 2004) study, the mean PaO2 perioperatively in the awake group = -3±1.5 mmHg and in the second group = -6.5±1.83 mmHg. Sample size of 40 cases per group (total 40) can detect this difference with power 100% and α-error 0.05.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Pleural Effusion, Malignant

Interventions

Thoracic Epidural AnesthesiaPROCEDURE

Group A pre-medicated once using Midazolam 3-4mg intravenous (IV) and Fentanyl 50mcg, placed in the setting position. Using a winged 18G (Gadge), 9cm length Tuohy Epidural needle, a 20G springwound closed tip epidural catheter be inserted between T3-T4. A test dose (5ml) 2% Lidocaine given, followed by 5-8 ml Bupivacaine 0.5% and 50mcg Fentanyl as a loading dose. Further top-up dose of 5 ml Bupivicaine 0.5% after 45 minutes.

General Anesthesia with One Lung VentilationPROCEDURE

Group B premedicated once by 3-4mg Midazolam IV, Ranitidine 50mg, Metoclopramide 10mg and Dexamethasone 4mg. Preoxygenation with 100% O2. Induction of anesthesia with Propofol (2mg/kg) and Fentanyl (1mcg/kg). Tracheal intubation by 37-39 Fr Double Lumen Endotracheal Tube insertion facilitated with Cisatracurium 0.1mg/kg. and confirmation of its position by Fiberoptic Bronchoscopy. Selective Lung Ventilation strategy can be performed through the endobroncheal tube of the non operated lung once needed. Anesthesia maintained with Isoflurane (1-2%) and Cisatracurium (0.05mg/kg per dose). Later, anesthesia discontinued and extubation after full neuromuscular recovery after reversal of muscle relaxant by Neostigmine (0.05mg/kg) and Atropine (0.02mg/kg).

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * ASA less than or equal II. * The procedure expected to be completed within 2 hours. Exclusion Criteria: * Patients with expected difficult airway management. * Hemodynamically unstable patients. * Persistent cough or high airway secretions. * Severe Emphysema or clinical signs of active infectious disease. * Hypoxemia (PaO2 \<60 mmHg) or hypercarbia (PCO2 \>50 mmHg) * Coagulopathy (INR \>1.5). * Obesity (BMI \>30 Kg/m 2 ). * Infection at the injection site, allergy to local anesthetics. * Neurological disorders: seizures, intracranial mass or brain edema.

Outcomes

Primary Outcomes

Perioperative changes in blood gases

Ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2), arterial carbon dioxide tension (PaCO2). Hypoxemia is defined as peripheral oxygen saturation (SpO2) \< 92% on room air with a need for oxygen supplementation.

Time frame: Imediately before operation, intraoperatively per hour, and postoperatively till 24 hours

Secondary Outcomes

Postoperative pain

The Visual Analogue Scale (VAS) consists of a 10 cm straight line with the endpoints defining extreme limits of "no pain at all" (0 cm) and "pain as bad as it could be" (10 cm). The patient is asked to mark his pain level on the line between the two endpoints. The distance between 0 and the mark then defines the subject pain score.

Time frame: Postoperatively at 3,12 and 24 hours

Postoperative opioid needs

Pethidine consumption

Time frame: Postoperatively during the 24 hours after regaining sensation

Hospital stay

Time frame: from day of operation to discharge; average, 5 days

Perioperative changes in heart rate

heart rate (HR) in beats per minute (bpm)

Time frame: Immediately before the operation, intraoperatively per hour, and postoperatively till 24 hours

The onset of ambulance.

Rate of occurence of falling after ambulance will be recorded in each group.

Time frame: During the 24 hours after regaining of full motor power

Number of episodes of Post Operative Nausea and Vomiting (PONV)

Time frame: During the 24 hours postoperatively

Perioperative changes in mean arterial pressure

mean arterial pressure (MAP) in mmHg