Throid SurgeryNCT07325669
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
A study testing tıva in people with Throid Surgery and Airway Complication of Anaesthesia, run by dilara gocmen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Throid Surgery, Airway Complication of Anaesthesia, Coughing Responses at Tracheal Extubation
- What is being tested?
- tıva
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- • 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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
- Being tested
- tıva
- Keywords
- airway complication of anesthesia, tiroid surgery, propofol anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tıvaDrug
Also called volatile agent
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: tıva |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: first 10 min after extubation
Secondary outcomes (4)
presence of post-extubation desaturation(spO2<92%)
An SpO2 level below 92% will be considered as indicating the development of postoperative desaturation.
Measured: first 30min after extubation
requirement for re-intubation
Re-intubation of a patient who cannot be ventilated or oxygenated after extubation
Measured: first 30 min after extubation
Positive pressure mask ventilation support
The need for chin lift and mask ventilation after extubation
Measured: 30 min after extubation
postoperative care unit Richmond agitation scale score(+4,-5)
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
Measured: postoperative recovery period(30.min after extubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Throid SurgeryStudies 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- dilara gocmen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, dilara gocmen, Marmara University Pendik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325669
- Sponsor's protocol ID
- 2025/17/1234
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07325669
- Acronym / sponsor ID
- 2025/17/1234
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- dilara gocmenUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group TIVA-TCI | Experimental | Drug: tıvaAnaesthesia 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. |
| Group Volatile anesthesia | Experimental | Drug: tıvaAnaesthesia 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- • History of difficult intubation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tıvaAlso: volatile agentIn 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. | Drug | Group Volatile anesthesia, group TIVA-TCI |
Primary outcome
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)
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.
4 secondary outcomes
presence of post-extubation desaturation(spO2<92%)
Time frame: first 30min after extubation
requirement for re-intubation
Time frame: first 30 min after extubation
Positive pressure mask ventilation support
Time frame: 30 min after extubation
postoperative care unit Richmond agitation scale score(+4,-5)
Time frame: postoperative recovery period(30.min after extubation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing tıva in people with Throid Surgery and Airway Complication of Anaesthesia, run by dilara gocmen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dilara Göçmen (+905413439438, dilaragocmen@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative cough score(0-3) (time frame: first 10 min after extubation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.