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

September 30, 2021 updated by: Mohamed Reda Ashour

A Comparative Study Between Thoracic Epidural Anesthesia in Non-Intubated Video-Assisted Thoracoscopes and the Conventional General Anesthesia With One Lung Ventilation

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 1156
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group A
sole Thoracic Epidural Anesthesia
Procedure: Thoracic Epidural Anesthesia
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.
ACTIVE_COMPARATOR: Group B
General Anesthesia with One Lung Ventilation
Procedure: General Anesthesia with One Lung Ventilation
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative changes in blood gases
Time Frame: Imediately before operation, intraoperatively per hour, and postoperatively till 24 hours
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.
Imediately before operation, intraoperatively per hour, and postoperatively till 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital stay
Time Frame: from day of operation to discharge; average, 5 days
from day of operation to discharge; average, 5 days
Postoperative pain
Time Frame: Postoperatively at 3,12 and 24 hours
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.
Postoperatively at 3,12 and 24 hours
Postoperative opioid needs
Time Frame: Postoperatively during the 24 hours after regaining sensation
Pethidine consumption
Postoperatively during the 24 hours after regaining sensation
Perioperative changes in heart rate
Time Frame: Immediately before the operation, intraoperatively per hour, and postoperatively till 24 hours
heart rate (HR) in beats per minute (bpm)
Immediately before the operation, intraoperatively per hour, and postoperatively till 24 hours
The onset of ambulance.
Time Frame: During the 24 hours after regaining of full motor power
Rate of occurence of falling after ambulance will be recorded in each group.
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
During the 24 hours postoperatively
Perioperative changes in mean arterial pressure
Time Frame: Immediately before the operation, intraoperatively per hour, and postoperatively till 24 hours
mean arterial pressure (MAP) in mmHg
Immediately before the operation, intraoperatively per hour, and postoperatively till 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohamed Reda Ashour

Investigators

  • Study Chair: Samia A M Abdel Latif, Professor, Department of Anesthesia, Intensive care and pain management, Ain Shams University.
  • Study Director: Waleed El Taher, Professor, Department of Anesthesia, Intensive care and pain management, Ain Shams University.
  • Study Director: Hany H El Sayed, Professor, Department of Thoracic Surgery, Ain Shams University.
  • Study Director: Ahmed F Koraitim, MD, Department of Anesthesia, Intensive care and pain management, Ain Shams University.
  • Study Director: Mohamed A A alhadidy, MD, Department of Anesthesia, Intensive care and pain management, Ain Shams University.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 15, 2020

Primary Completion (ACTUAL)

September 15, 2021

Study Completion (ANTICIPATED)

October 15, 2021

Study Registration Dates

First Submitted

September 19, 2021

First Submitted That Met QC Criteria

September 30, 2021

First Posted (ACTUAL)

October 14, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 14, 2021

Last Update Submitted That Met QC Criteria

September 30, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU M D 389/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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