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

NCT04471597 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-10-10

No results posted yet for this study

Summary

* 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.

Conditions

  • Thyroid Diseases

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-20
Primary Completion
2023-08-01
Completion
2023-09-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04471597 on ClinicalTrials.gov