NCT04471597

Topical Bupivacaine Effect On The Response To Awake Extubation During Emergence From General Anesthesia

Completed NA Last updated 10 October 2023

What this trial tests

NA trial testing normal saline 0.9% in Thyroid Diseases in 48 participants. Completed in 1 September 2023.

Timeline

20 July 2020

Primary endpoint
1 August 2023

1 September 2023

Quick facts

Lead sponsor	Zagazig University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	48
Start date	20 July 2020
Primary completion	1 August 2023
Estimated completion	1 September 2023
Sites	1 location across Egypt

Drugs / interventions tested

• normal saline 0.9%
• Bupivacaine Hydrochloride (Bupivacaine Hydrochloride) — full drug profile →

Conditions studied

• Thyroid Diseases — all drugs for Thyroid Diseases →

Sponsor

Zagazig University

Who can join

Adults 21 to 60, any sex, with Thyroid Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.