Tracheal ExtubationPhase 4NCT07857356
Remifentanil Versus Remifentanil-Lidocaine for Tracheal Extubation After Thyroidectomy
A Phase 4 study testing remifentanil and Lidocaine %2 ampoule in people with Tracheal Extubation and Cough, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tracheal Extubation, Cough
- What is being tested?
- remifentanil and Lidocaine %2 ampoule
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2026to Nov 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Pamukkale University Hospitals
Denizli
SAADET NUR YALCIN SATICI, +905066474672, yalcinsaadetnur@gmail.com
About this study
Official title: Comparison of the Effects of Remifentanil and Remifentanil-Lidocaine Combination on Tracheal Extubation Quality in Patients Undergoing Thyroidectomy
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.
Read the 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.
- Conditions
- Tracheal Extubation, Cough
- Being tested
- remifentanil, Lidocaine %2 ampoule
- Keywords
- Thyroidectomy, Remifentanil, Lidocaine, Tracheal Extubation, Cough, Emergence From Anesthesia
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remifentanilDrug
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 ampouleDrug
Lidocaine 1.5 mg/kg will be administered intravenously as a slow bolus over 1-2 minutes during surgical dressing before tracheal extubation.
| Study group | Role | What they receive |
|---|---|---|
| remifentanil group | Active comparator | 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. Receives: Drug: remifentanil |
| lidocaine-remifentanil | Experimental | 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. Receives: Drug: remifentanil; Drug: Lidocaine %2 ampoule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During tracheal extubation
Secondary outcomes (3)
Hemodynamic Response During Extubation
Heart rate will be recorded to evaluate the hemodynamic response to tracheal extubation.
Measured: Before extubation, at extubation, and at 1 and 5 minutes after extubation
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.
Measured: At 1 hours and 24 hours after surgery
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.
Measured: At 1 hours and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal ExtubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, saadet nur yalçın satıcı, Pamukkale University
- Investigators
- saadet nur YALCIN SATICI, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857356
- Sponsor's protocol ID
- 26-AKD-87
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No