Remifentanil Versus Remifentanil-Lidocaine for Tracheal Extubation After Thyroidectomy

NCT07857356 — Phase 4, Recruiting, 60 participants, Pamukkale University

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Comparison of the Effects of Remifentanil and Remifentanil-Lidocaine Combination on Tracheal Extubation Quality in Patients Undergoing Thyroidectomy

RegistryNCT07857356
StatusRecruiting
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: quadruple, prevention
Enrollment60 (Estimated)
SponsorPamukkale University (Other)
ConditionsTracheal Extubation, Cough
Interventionsremifentanil, Lidocaine %2 ampoule (Drug)
Datesstart 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
Locations1 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

-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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
remifentanil groupActive comparatorDrug: remifentanilRemifentanil 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-remifentanilExperimentalDrug: remifentanil; Drug: Lidocaine %2 ampouleParticipants 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.
  • remifentanil (Drug): 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 %2 ampoule (Drug): Lidocaine 1.5 mg/kg will be administered intravenously as a slow bolus over 1-2 minutes during surgical dressing before tracheal extubation.

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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.

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
Pamukkale University HospitalsDenizliTurkey (Türkiye)Recruiting

+Investigators

  • saadet nur YALCIN SATICI, Principal investigator, Pamukkale University