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Evaluation of the use of Topical Anesthesia in Thyroid surgery

Evaluation of the use of Topical Anesthesia on the airway with Lidocaine and Ropivacaine in patients undergoing Total Thyroidectomy surgery: a randomized study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-65p3f3s
Enrollment
Unknown
Registered
2025-04-09
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Thyroide Neoplasms

Interventions

This is a randomized, double-blind, controlled, four-arm clinical trial. A total of 100 patients undergoing total thyroidectomy will be randomly allocated into one of the four intervention groups, wit

Sponsors

Hospital São Domingos
Lead Sponsor
Hospital São Domingos
Collaborator

Eligibility

Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients undergoing total thyroidectomy; both genders; age between 18 and 70 years; American Society of Anesthesiologists (ASA) physical status classification I or II

Exclusion criteria

Exclusion criteria: Patients who refuse to participate in the study; difficult tracheal intubation (trachea not intubated after the first attempt); smoking patients; patients with heart, lung, or neurological diseases; patients with a history of previous laryngeal or tracheal surgery; patients at risk of aspiration of gastric contents; patients requiring the use of a nasogastric or orogastric tube

Design outcomes

Primary

MeasureTime frame
The primary outcome will be to record physiological reflexes upon extubation, such as cough and/or emesis, speech recovery time, dysphonia, dyspnea, hoarseness, whispering, complete aphonia, vocal fatigue, inability to sustain phonation and volume adequately, hemoptysis, airway inflammation, sore throat, fullness, and the sensation of a foreign body in the throat at time intervals of 2h, 6h, 18h, and 24h after awakening

Secondary

MeasureTime frame
The secondary outcome will be to record the level of satisfaction, analyzing the variables of attention, information, privacy, waiting time, pain control, and discomfort. These variables will be assessed using closed-ended responses, categorized as: not satisfied, slightly satisfied, satisfied, very satisfied, and completely satisfied at time intervals of 2h, 6h, 18h, and 24h after awakening

Countries

Brazil

Contacts

Public ContactPlinio da Cunha Leal

Hospital São Domingos

plinio.cunha@ufma.br+55 (98) 3216-8107

Outcome results

None listed

Source: REBEC (via WHO ICTRP)