Tracheal Extubation, Cough
Conditions
Keywords
Thyroidectomy, Remifentanil, Lidocaine, Tracheal Extubation, Cough, Emergence From Anesthesia
Brief summary
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.
Detailed description
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.
Interventions
DRUGremifentanil
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 1.5 mg/kg will be administered intravenously as a slow bolus over 1-2 minutes during surgical dressing before tracheal extubation.
Sponsors
Pamukkale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
An independent unblinded researcher will prepare identical syringes labeled "Study Drug" according to the randomization list. Participants, anesthesia care providers, investigators, and outcome assessors will be blinded to group allocation. The person preparing the study medication will not participate in perioperative management or outcome assessment.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to one of two parallel treatment groups: remifentanil alone or remifentanil combined with intravenous lidocaine.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Cough During Tracheal Extubation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic Response During Extubation | Before extubation, at extubation, and at 1 and 5 minutes after extubation | Heart rate will be recorded to evaluate the hemodynamic response to tracheal extubation. |
| Incidence of Postoperative Sore Throat | At 1 hours and 24 hours after surgery | 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. |
| Incidence of Postoperative Hoarseness | At 1 hours and 24 hours after surgery | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTsaadet nur YALCIN SATICI
PRINCIPAL_INVESTIGATORsaadet nur YALCIN SATICI
Pamukkale University
Outcome results
None listed