Comparison of the Effects of Remifentanil and Remifentanil-Lidocaine Combination on Tracheal Extubation Quality in Patients Undergoing Thyroidectomy
| Registry | NCT07857356 |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: quadruple, prevention |
| Enrollment | 60 (Estimated) |
| Sponsor | Pamukkale University (Other) |
| Conditions | Tracheal Extubation, Cough |
| Interventions | remifentanil, Lidocaine %2 ampoule (Drug) |
| Dates | start 2026-10-01 (estimated), primary completion 2026-11-01 (estimated), completion 2026-11-01 (estimated), first posted 2026-10-05, last updated 2026-10-08 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Tracheal Extubation All trials for Cough All trials of remifentanil All trials of Lidocaine %2 ampoule
This randomized, double-blind clinical trial will compare the effects of remifentanil alone and remifentanil combined with intravenous lidocaine on the quality of tracheal extubation in adult patients undergoing elective thyroidectomy under general anesthesia.
A total of 60 patients will be randomly assigned to two groups. Both groups will receive remifentanil during emergence from anesthesia, while one group will additionally receive intravenous lidocaine before extubation.
The primary outcome will be the incidence of coughing during tracheal extubation. Secondary outcomes will include cough severity, hemodynamic responses, oxygen saturation, airway-related adverse events, postoperative sore throat, hoarseness, postoperative nausea and vomiting, sedation level, and recovery and extubation times.
Tracheal extubation may be associated with coughing and hemodynamic responses, which may be undesirable after thyroid surgery. Pharmacological strategies such as remifentanil and intravenous lidocaine may attenuate airway reflexes during emergence from general anesthesia.
This prospective, randomized, double-blind, parallel-group study is designed to evaluate whether the addition of intravenous lidocaine to remifentanil improves the quality of tracheal extubation compared with remifentanil alone in patients undergoing elective thyroidectomy.
Sixty adult patients will be randomly allocated in a 1:1 ratio to receive either remifentanil alone or remifentanil combined with intravenous lidocaine during emergence from anesthesia. Extubation conditions, coughing, hemodynamic variables, respiratory events, recovery characteristics, and postoperative airway-related symptoms will be evaluated.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| remifentanil group | Active comparator | Drug: remifentanil | Remifentanil will be administered intravenously at 0.02-0.06 µg/kg/min during anesthesia and titrated according to the study protocol during the emergence period. |
| lidocaine-remifentanil | Experimental | Drug: remifentanil; Drug: Lidocaine %2 ampoule | Participants assigned to this group will receive remifentanil according to the same study protocol and intravenous lidocaine 1.5 mg/kg as a slow bolus over 1-2 minutes during surgical dressing before tracheal extubation. |
Sex: All, ages: 18 Years to 65 Years
Inclusion Criteria: * Age 18 to 65 years American Society of Anesthesiologists (ASA) physical status I or II Scheduled for elective thyroidectomy under general anesthesia Body mass index (BMI) <35 kg/m² Able to provide written informed consent Exclusion Criteria: * History of chronic respiratory disease, including asthma or chronic obstructive pulmonary disease (COPD) Active upper or lower respiratory tract infection Known airway abnormality or anticipated difficult airway Known allergy or hypersensitivity to lidocaine Planned postoperative intubation or extubation in the intensive care unit Refusal to participate or withdrawal of consent
| Facility | City | Country | Status |
|---|---|---|---|
| Pamukkale University Hospitals | Denizli | Turkey (Türkiye) | Recruiting |