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NCT Number: NCT07325669

Comparison of the Effects of Total Intravenous Anaesthesia With Target-Controlled Infusion (TCI) and Inhalation Anaesthesia on Airway Complications During Extubation and in the Early Postoperative Period in Thyroidectomy Surgery

Thyroid surgery is one of the most complex operations in the head and neck region due to its close relationship with anatomical structures and the high risk of recurrent laryngeal nerve injury. The proximity of the surgical field to the trachea and larynx increases the likelihood of postoperative airway complications. Common complications include hypoparathyroidism (HP), recurrent laryngeal nerve (RLN) injury, injury to the external branch of the superior laryngeal nerve (EBLN), postoperative bleeding, thoracic canal injury, laryngeal oedema, tracheospasm, tracheal injury, and oesophageal injury. Serious complications such as dyspnoea, asphyxia, or thyroid crisis can lead to patient death.

Severe hypertension or coughing during awakening and extubation may cause bleeding from the surgical site, along with possible haematoma formation. In this context, safe extubation, maintenance of postoperative airway patency, and prevention of early complications are critical components of anaesthesia management in thyroid surgery.

Currently used anaesthesia techniques can directly affect the quality of the recovery process, the sensitivity of airway reflexes, and the reliability of nerve monitoring techniques. Total intravenous anaesthesia (TIVA) regimens, particularly when administered via target-controlled infusion (TCI) systems, allow for more precise control of anaesthetic depth and provide a more predictable, stable transition during the extubation period. In target-controlled intravenous anaesthesia, bolus and infusion of the anaesthetic agent are administered to achieve the desired target concentration based on the pharmacokinetic models of the drug according to the patient's age, gender, height, and weight. Various studies have indicated that the combination of propofol and remifentanil causes fewer complications such as agitation, coughing, and laryngospasm during the recovery period; in contrast, volatile agents such as sevoflurane may trigger undesirable effects such as increased secretion in the respiratory tract and laryngeal sensitivity more frequently.

Furthermore, intraoperative neuromonitoring (IONM) applications are increasingly being used to prevent recurrent laryngeal nerve injuries. However, the accuracy and signal quality of this technology are directly affected by the impact of the anaesthetic regimen on nerve-muscle transmission. The literature has shown that inhalation anaesthetics may weaken IONM responses by suppressing synaptic transmission, whereas TIVA provides more reliable and stable signal transmission. A study comparing propofol and inhalation anaesthesia in patients with papillary thyroid carcinoma showed that propofol-based total intravenous anaesthesia was associated with fewer postoperative recurrences.

In a study comparing TCI-TIVA and sevoflurane inhalation anaesthesia in laparoscopic cholecystectomy surgery, TCI was reported to be associated with less postoperative nausea and vomiting and haemodynamic instability. In a study involving 50 patients undergoing lumbar disc surgery who received general anaesthesia with sevoflurane-fentanyl and propofol-remifentanil, less coughing and haemodynamic instability during awakening were observed in the TIVA group.

The hypothesis of this study is that TIVA administered using the TCI method will result in fewer airway complications after extubation and higher intraoperative neuromonitoring signal quality compared to inhalation anaesthesia. The study will comparatively evaluate the advantages and disadvantages of two different anaesthesia techniques in terms of both postoperative airway safety and haemodynamics, as well as intraoperative nerve monitoring.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or older,
  • Classified as ASA I-II,
  • Undergoing elective primary total or subtotal thyroidectomy surgery,
  • Patients undergoing intraoperative neuromonitoring will be included in the study.

Exclusion criteria

  • • History of difficult intubation,
  • History of neuromuscular disease,
  • Current vocal cord paralysis,
  • Previous neck surgery
  • Patients with a body mass index above 35 kg/m² were defined as morbidly obese.

Treatment and study plan

tıva

Drug

In the TIVA group (total intravenous anaesthesia group), induction and maintenance of anaesthesia will be performed using target-controlled infusion (TCI) with propofol (Schneider model) and remifentanil (Minto model). In Group VA (volatile/inhalation anaesthesia group), maintenance anaesthesia will be administered with sevoflurane and remifentanil infusion following intravenous induction.

Other names: volatile agent

Primary outcomes

  1. postoperative cough score(0-3)

    Time frame: first 10 min after extubation

    Grade 0: No cough Grade 1: Mild, single cough Grade 2: Moderate cough lasting less than 5 seconds Grade 3: Severe, continuous cough lasting longer than 5 seconds (bucking)

  2. postoperative laryngospasm score (0-3)

    Time frame: first 10 min after extubation

    Grade 0: No symptoms Grade 1: Stridor Grade 2: Complete obstruction of the vocal cords (breathing efforts without air movement) Grade 3: Cyanosis with evidence of airway obstruction at the level of the vocal cords.

Secondary outcomes

  1. presence of post-extubation desaturation(spO2<92%)

    Time frame: first 30min after extubation

    An SpO2 level below 92% will be considered as indicating the development of postoperative desaturation.

  2. requirement for re-intubation

    Time frame: first 30 min after extubation

    Re-intubation of a patient who cannot be ventilated or oxygenated after extubation

  3. Positive pressure mask ventilation support

    Time frame: 30 min after extubation

    The need for chin lift and mask ventilation after extubation

  4. postoperative care unit Richmond agitation scale score(+4,-5)

    Time frame: postoperative recovery period(30.min after extubation)

    postoperative care unit Richmond agitation scale score

    • 4 ->Combative-> Overtly combative or violent; immediate danger to staff
    • 3 ->Very agitated-> Pulls on or removes tube(s) or catheter(s) or has aggressive behavior toward staff
    • 2 Agitated ->Frequent nonpurposeful movement or patient-ventilator dys-synchrony
    • 1 Restless Anxious or apprehensive but movements not aggressive or vigorous 0 Alert and calm Spontaneously pays attention to caregiver
    • 1 Drowsy Not fully alert, but has sustained (more than 10 seconds) awakening, with eye contact, to voice
    • 2 Light sedation Briefly (less than 10 seconds) awakens with eye contact to voice
    • 3 Moderate sedation Any movement (but no eye contact) to voice
    • 4 Deep sedation No response to voice, but any movement to physical stimulation
    • 5 Unarousable No response to voice or physical stimulation

Study contacts

Contact information is provided by the study sponsor or research team.

Dilara Göçmen

CONTACT

[email protected]

+905413439438

Sponsors and collaborators

Lead sponsor

dilara gocmen

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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