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Use of local anesthetics as a strategy to reduce cough, respiratory complications, and blood pressure changes during tracheal tube removal after general anesthesia

Effects of intracuff Lidocaine and periglottic Ropivacaine, alone or in combination, on Extubation quality, airway morbidity, and hemodynamic stability during elective general anesthesia: A randomized controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-6zppq5h
Enrollment
400
Registered
2026-04-17
Start date
2026-03-10
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Extubation

Interventions

This is a randomized, controlled, parallel-group, double-blind clinical trial. Participants will be allocated through a computer-generated random sequence using the RedCap platform, with block randomi
20–25 cmH2O measured with a transducer) + periglottic instillation of 8 mL saline solution.Group 2 – Intracuff Lidocaine Cuff filled with alkalinized 2% lidocaine (1 mL of 8.4% sodium bicarbonate for
volume 5–7 mL, pressure &lt
20–25 cmH2O) + 8 mL periglottic saline solution.. Group 3 – Periglottic Ropivacaine - Bilateral periglottic instillation of 0.5% ropivacaine (8 mL) + cuff filled with saline solution. Group 4 – Combin

Sponsors

Departamento de Anestesiologia do Hospital das Clínicas da Faculdade de Medicina de Botucatu (HCFMB) Unesp
Lead Sponsor
Departamento de Anestesiologia do Hospital das Clínicas da Faculdade de Medicina de Botucatu (HCFMB) Unesp
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age =18 years; both sexes; ASA Physical Status Classification System I–III; elective ophthalmologic surgery under general anesthesia with orotracheal intubation; signed informed consent

Exclusion criteria

Exclusion criteria: Allergy to local anesthetics; Acute respiratory illness; Predicted or completed difficult intubation; Previous tracheostomy; Severe gastroesophageal reflux; Inability to understand assessment scales; Participant refusal

Design outcomes

Primary

MeasureTime frame
It is expected that there will be a reduction in the incidence and intensity of cough during extubation in the groups receiving local anesthetics. The outcome will be verified using the Minogue Cough Scale for extubation, applied at the time of endotracheal tube removal. The proportions of patients classified in the different grades of the scale (0–3) will be observed and compared, as well as the reduction in the incidence of moderate or intense cough between the studied groups.

Secondary

MeasureTime frame
A reduction in the incidence of postoperative airway symptoms and complications is expected. The outcome will be verified through a standardized questionnaire administered to patients and anesthesiologists postoperatively. The incidences of sore throat, cough, hoarseness, bronchospasm, and laryngospasm in the first 24 hours after surgery will be observed and compared between the study groups.;It is expected that there will be less hemodynamic disruption during the extubation period in the groups receiving local anesthetics. The outcome will be verified by monitoring intraoperative hemodynamic parameters. Variations in blood pressure and heart rate will be observed and compared before, during, and after extubation between the study groups.

Countries

BR

Contacts

Public ContactThales de Souza

Departamento de Anestesiologia do Hospital das Clínicas da Faculdade de Medicina de Botucatu (HCFMB) Unesp

thalesfsouza@hotmail.com+55-035-987087995

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: May 1, 2026