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

NCT07325669 | Not Yet Recruiting

• 1 other identifier: 2025/17/1234
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Throid Surgery; Airway Complication of Anaesthesia; Coughing Responses at Tracheal Extubation; Laryngospasm on Emergence; Target Controlled Infusion of Propofol; Sevoflurane Anaesthesia

Keywords

airway complication of anesthesia; tiroid surgery; propofol anesthesia

Outcome Measures

Primary Outcomes (2)

• postoperative cough score(0-3)

  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)

  first 10 min after extubation

• postoperative laryngospasm score (0-3)

  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.

  first 10 min after extubation

Secondary Outcomes (4)

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

  first 30min after extubation

• requirement for re-intubation

  first 30 min after extubation

• Positive pressure mask ventilation support

  30 min after extubation

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

  postoperative recovery period(30.min after extubation)

Study Arms (2)

group TIVA-TCI

EXPERIMENTAL

Anaesthesia induction will be achieved in all patients with 2 µg/kg remifentanil and 2-2.5 mg/kg propofol. In the TCI group, propofol will be administered using Medcaptain IV perfusors, with the target concentration at the site of action set at 3-4 µg/mL according to the Schneider model; remifentanil will be set at 2-4 ng/mL according to the Minto model (the CE certificate for the perfusor and TCI models is available and has been added to the file). All patients will receive rocuronium 0.6 mg/kg as a muscle relaxant, and intubation will be performed using an endotracheal tube with EMG electrodes. After intubation, the cuff pressure will be optimised to 20-30 cmH₂O using a manometer. No repeat muscle relaxant will be administered. During anaesthesia maintenance, propofol and remifentanil (propofol 3-4 µg/mL, remifentanil 2-4 ng/mL) will be administered via TCI in Group TIVA.

Drug: tıva

Group Volatile anesthesia

EXPERIMENTAL

Anaesthesia induction will be achieved in all patients with 2 µg/kg remifentanil and 2-2.5 mg/kg propofol. In Group VA, sevoflurane MAC will be maintained at 1-1.2, and remifentanil infusion will be administered at a rate of 0.1-0.3 µg/kg/min. In both groups, anaesthesia depth will be monitored using BIS, and values will be maintained within the range of 40-60.

Drug: tıva

Interventions

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.

Also known as: volatile agent

Group Volatile anesthesia; group TIVA-TCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• dilara gocmen: lead

Central Study Contacts

Dilara Göçmen

CONTACT

+905413439438; dilaragocmen@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: asst. Prof

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 8, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 8, 2026

Record last verified: 2025-12