Injury of thoracic trachea
Conditions
Interventions
Randomized controlled clinical study with three parallel arms and single blind masking to be conducted in adult patients with a total sample of one hundred and eleven participants equally allocated in
Sponsors
Rede D'Or São Luiz S.A.
Rede D&apos
Or São Luiz S.A.
Hospital e Maternidade São Luiz
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult patients aged 18 years or older; classified as physical status I or II according to the American Society of Anesthesiologists; Mallampati classification grades I to III, with grade III accepted only in the absence of other predictors of a difficult airway; scheduled for elective laparoscopic pelvic surgery; indication for general anaesthesia combined with spinal anaesthesia; requirement for planned orotracheal intubation; surgical positioning in the supine position with a mild Trendelenburg tilt; both sexes
Exclusion criteria
Exclusion criteria: Refusal to participate in the study; presence of sore throat in the preoperative period; active smoking; prior history of oral or nasal surgery; active upper respiratory tract infection; pregnancy; chronic obstructive pulmonary disease; known allergy to any of the medications used in the study; increased risk of aspiration or gastro-oesophageal reflux; requirement for nasogastric tube insertion intraoperatively; presence of clinically relevant cardiopulmonary, neuromuscular, renal, or hepatic disease; use of succinylcholine; requirement for rapid sequence induction; anticipated difficult airway defined as Mallampati classification grade IV; need for more than one orotracheal intubation attempt; patients with a prior history of laryngeal disease; previous tracheostomy; chronic users of opioids or illicit drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to assess the occurrence and intensity of postoperative sore throat in patients undergoing orotracheal intubation during pelvic laparoscopic surgery, verified through serial assessments using the Numeric Rating Scale, applied at 1 hour, 6 hours, and 24 hours after extubation, with the outcome defined as the presence of continuous throat pain or discomfort independent of swallowing and quantified on a scale from 0 to 10, in which higher values indicate greater symptom intensity | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to assess the occurrence and intensity of postoperative hoarseness and dysphagia, verified through serial clinical assessments using a Numeric Symptom Intensity Scale at the same time points as the primary outcome, with hoarseness defined as difficulty or pain during phonation and dysphagia defined as difficulty or pain during swallowing, both quantified on a scale from 0 to 10, in which higher values indicate greater symptom severity | — |
Countries
Brazil
Contacts
Public ContactSaullo Silveira
Rede D'Or São Luiz S.A.
Outcome results
None listed