Remifentanil Versus Remifentanil-Lidocaine for Tracheal Extubation After Thyroidectomy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPamukkale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
remifentanil
DrugRemifentanil 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 %2 ampoule
DrugLidocaine 1.5 mg/kg will be administered intravenously as a slow bolus over 1-2 minutes during surgical dressing before tracheal extubation.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: remifentanil groupActive comparator 1 intervention
Group B: lidocaine-remifentanilExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Incidence of Cough During Tracheal Extubation
Cough will be assessed during tracheal extubation. The presence or absence of cough will be recorded for each participant. Cough severity will also be graded using a 4-point cough scale, with higher scores indicating more severe coughing.
Time frame
During tracheal extubationSecondary outcomes
1
Hemodynamic Response During Extubation
Heart rate will be recorded to evaluate the hemodynamic response to tracheal extubation.
Time frame
Before extubation, at extubation, and at 1 and 5 minutes after extubation2
Incidence of Postoperative Sore Throat
Postoperative sore throat will be assessed using a 4-point severity scale: 0 = no sore throat, 1 = mild sore throat, 2 = moderate sore throat, and 3 = severe sore throat. Postoperative sore throat will be defined as a score ≥1.
Time frame
At 1 hours and 24 hours after surgery3
Incidence of Postoperative Hoarseness
Postoperative hoarseness will be assessed using a 4-point severity scale: 0 = no hoarseness, 1 = mild hoarseness, 2 = moderate hoarseness, and 3 = severe hoarseness. Postoperative hoarseness will be defined as a score ≥1.
Time frame
At 1 hours and 24 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov