Skip to main content
Clinical Trials/NCT03098667
NCT03098667
Completed
Not Applicable

Study of the Laryngopharyngeal Symptoms After Minimally Invasive Thyroidectomy: Comparison Between the Protector Laryngeal Mask Airway and the Endotracheal Tube.

424 General Military Hospital1 site in 1 country79 target enrollmentFebruary 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sore Throat
Sponsor
424 General Military Hospital
Enrollment
79
Locations
1
Primary Endpoint
Postoperative sore throat.
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The patients will be allocated to 2 groups: the LMA group and the endotracheal tube (ET) group. Airway management will be done with the LMA Protector for the patients of the LMA group and with the classic endotracheal tube for the patients of the ET group. The main purpose of the study is to determine if the application of the LMA Protector causes less laryngopharyngeal symptoms than the endotracheal tube after minimally invasive thyroidectomy. The secondary purpose is to confirm that the LMA Protector is a safe alternative airway management device for minimally invasive thyroidectomy.

Registry
clinicaltrials.gov
Start Date
February 1, 2017
End Date
November 1, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Georgios Kotsovolis

Dr Georgios Kotsovolis

424 General Military Hospital

Eligibility Criteria

Inclusion Criteria

  • Total thyroidectomy with the minimally invasive method.
  • American Society of Anesthesiologists (ASA) classification 1-3

Exclusion Criteria

  • Clinical conditions which cause any kind of airway obstruction or compromise.
  • Tracheal displacement greater than 2cm from midline.
  • History of gastroesophageal reflux disease.
  • Expected difficult airway.
  • History of impossible intubation.
  • Reoperation within 24hours.

Outcomes

Primary Outcomes

Postoperative sore throat.

Time Frame: 24 hours after the exit from the recovery room.

The patients will be asked to evaluate their postoperative constant pharyngeal pain by using the 11grade Numerical Rating Scale (0 no pain, 10 maximum possible pain).

Postoperative surgical site pain.

Time Frame: 24 hours after the exit from the recovery room.

The patients will be asked to evaluate their postoperative surgical trauma pain by using the 11grade Numerical Rating Scale (0 no pain, 10 maximum possible pain).

Postoperative dysphagia.

Time Frame: 24 hours after the exit from the recovery room.

The patients will be asked to evaluate their postoperative pharyngeal pain caused after swallowing one sip of water by using the 11grade Numerical Rating Scale (0 no pain, 10 maximum possible pain).

Secondary Outcomes

  • Airway management difficulty.(3 minutes after induction of general anesthesia.)
  • Airway management complications.(Within 5 minutes from induction of general anesthesia.)
  • Postoperative paracetamol consumption.(1, 6, 12 and 24 hours after emergence from general anesthesia.)
  • Emergence coughing.(Within 10 minutes from the end of the surgery.)
  • Postoperative hoarseness.(Within 20 minutes from the end of the procedure and after 1, 6, 12 and 24 hours.)

Study Sites (1)

Loading locations...

Similar Trials