Clinical trial

Topical Bupivacaine Effect On The Response To Awake Extubation During Emergence From General Anesthesia In Patients Undergoing Elective Thyroidectomy. A Randomized Controlled Study

Name

6201//12-7-2020

Description

* Emergence from general anesthesia is often complicated by the ETT-induced emergence phenomena (EP), which include coughing, sympathetic stimulation, sore throat, increased bleeding from the surgical site, and increased intracranial and intraocular pressures. * Techniques that have been used to help diminish coughing during emergence include "deep" extubation (removal of the endotracheal tube \[ETT\] while the patient is still in a deep plane of general anesthesia), administration of intravenous (IV) narcotics, or administration of IV lidocaine prior to emergence since systemic narcotics and lidocaine have antitussive properties. However, each of these techniques has limitations. A reliable technique for improving ETT tolerance while facilitating rapid and full emergence from general anesthesia would be desirable in many situations. * Topical application of bupivacaine to the pharyngeal, laryngeal, and tracheal mucosa will attenuate or even abolish coughing as well as a hemodynamic response during extubation, thus result in increasing the patient's comfort and avoiding potential complications of extubation process. * Up to the investigator's knowledge there is no study done to evaluate the effect of topical bupivacaine on the incidence of coughing and hemodynamic response during emergence from general anesthesia in patients undergoing elective thyroidectomy.

Trial arms

Trial start

2020-07-20

Estimated PCD

2023-08-01

Trial end

2023-09-01

Status

Completed

Treatment

normal saline 0.9%

5ml of normal saline 0.9% topically 15 min will be installed topically around the ETT using ordinary syringe before the expected end of the surgery, this will be followed by manual ventilation using about the double tidal volume for 6-8 times or more to get air bubbles distributed within the upper airway to anesthetize the oropharynx and spread around ETT to the adjacent mucosal structures (laryngopharynx, larynx, and upper part of the trachea) then the cuff will be inflated to the previous pressure and the patient will be mechanically ventilated as usual.

Arms:

Control group

Bupivacaine Hydrochloride

5 ml of bupivacaine 0.5% will be installed topically around the ETT using ordinary syringe before the expected end of the surgery, this will be followed by manual ventilation using about the double tidal volume for 6-8 times or more to get air bubbles distributed within the upper airway to anesthetize the oropharynx and spread around ETT to the adjacent mucosal structures (laryngopharynx, larynx, and upper part of the trachea) then the cuff will be inflated to the previous pressure and patient will be mechanically ventilated as usual.

Arms:

bupivacaine group

Size

Primary endpoint

Grade of coughing

procedure (measured within the extubation time)

Eligibility criteria

Inclusion Criteria: Patient acceptance. BMI \< 35kg/m2. ASA I and ASA II. Scheduled for elective thyroidectomy under general anesthesia Exclusion Criteria: Patient refusal. History or anticipated difficult intubation. Chronic respiratory disease such as chronic obstructive pulmonary disease or asthma. Recent respiratory tract infection in the last month, chronic cough, and current smoking. History of laryngeal or tracheal surgery or pathology. Patients with symptomatic gastric reflux. Patients with a known history of allergy to study drugs.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients will be divided randomly by a computer-generated randomization table into two equal groups', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'double-blinded ( patient and outcome assessors)', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 48, 'type': 'ACTUAL'}}

Updated at

2023-10-10

1 organization

2 products

1 indication

Organization

Product

Indication

Product