This study aims to assess whether pressure supporting ventilation and electroencephalogram (EEG)-guided emergence can reduce airway complications after thyroid surgery compared with conventional emergence. Patients will be randomly assigned to either pressure supporting ventilation and EEG-guided emergence group (intervention group) or conventional emergence group (control group). Co-primary outcomes are the incidence of emergence coughing and lowest percutaneous oxygen saturation (SpO2) after emergence. Secondary outcomes included severity of emergence cough, emergence time, blood pressure and heart rate during emergence, Richmond Agitation-Sedation Scale (RASS) immediately after extubation and upon post-anesthesia care unit (PACU) arrival, incidence of desaturation during PACU stay, hoarseness, sore throat during PACU stay, duration of PACU stay, surgeon satisfaction regarding emergence process, postoperative pain score, and patient satisfaction score regarding emergence process.
Adult patients aged \< 40 years scheduled to undergo thyroid surgery will be screened for eligibility. Patients will be randomly allocate to either the intervention group or control group. * In the intervention group, pressure support ventilation will be applied from the start of subcutaneous suture until extubation. At the end of surgery, sevoflurane will be discontinued, and the attending anesthesiologist will perform tracheal extubation after observing the 'zipper opening' pattern on the EEG spectrogram, indicating the patient's recovery of consciousness. For safety reason, extubation will also be guided by the following processed EEG indices thresholds: 1. 95% spectral edge frequency (SEF) ≥ 23 2. Patient state index (PSI) ≥ 64 * In the control group, conventional full-awake extubation will be performed based on the routine practice of our institution. At the end of surgery, sevoflurane will be stopped, and the attending anesthesiologist will lead the emergence process, allowing the patient to breathe spontaneously and providing intermittent manual assistance if necessary. Extubation will be performed when the patient meets the following criteria: obeys commands such as eye-opening or hand-grip, tidal volume \> 5 ml/kg, end-tidal carbon dioxide \< 45 mmHg, spontaneous respiratory rate 10 to 20 breaths/min. In both groups, the Oxygen Reserve Index (ORi) will be monitored. Blinded investigator will assess the incidence of emergence coughing and the lowest SpO2 after emergence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
120
Pressure support ventilation applied from the start of subcutaneous suture until extubation.
Volume-controlled mode during surgery, with intermittent manual assistance from the end of surgery until extubation.
Extubation criteria based on EEG findings:Zipper opening pattern observed in the spectrogram 95% spectral edge frequency (SEF) ≥ 23 Patient state index (PSI) ≥ 64
Extubation criteria include obeying commands (eye-opening or handgrip).
Extubation criteria include: Tidal volume \> 5 ml/kg End-tidal carbon dioxide (ETCO2) \< 45 mmHg Spontaneous respiratory rate (RR) 10 to 20 breaths/min
Gangnam Severance Hospital
Seoul, South Korea
RECRUITINGIncidence of emergence coughing
Incidence of emergence coughing (defined as coughing during the time period from sevoflurane off until 5 minutes after extubation)
Time frame: During the time period from sevoflurane cessation until 5 minutes after extubation
Lowest SpO2 after emergence
Lowest SpO2 after emergence (defined as the lowest SpO2 value during the time period from sevoflurane off to post-anesthesia care unit (PACU) discharge)
Time frame: During the time period from sevoflurane cessation until post-anesthesia care unit (PACU) discharge, an average of 1 hour
Severity of Emergence coughing
The severity of emergence coughing will be assessed using the modified 4-point Minogue scale, with grades assigned as follows: grade 1 (none), grade 2 (mild), grade 3 (moderate), or grade 4 (severe). A higher score indicates a more severe cough.
Time frame: During the time period from sevoflurane cessation until 5 minutes after extubation.
Incidence and severity of coughing during PACU stay
Incidence and severity of coughing during PACU stay evaluated using a modified 4-point Minogue scale.
Time frame: During the time period from PACU admission until PACU discharge, an average of 40 minutes
Emergence time
Time from sevoflurane cessation until tracheal extubation (minutes)
Time frame: During the time period from sevoflurane cessation until tracheal extubation, an average of 20 minutes
Time to leave operating room
Time from sevoflurane cessation until leaving operating room
Time frame: During the time period from sevoflurane cessation until leaving operating room, an average of 30 minutes
Blood pressure during emergence
systolic, diastolic, mean blood pressure (mmHg)
Time frame: during the time period from sevoflurane off until 5 minutes after extubation
Heart rate during emergence
Heart rate (beats per minute)
Time frame: during the time period from sevoflurane off until 5 minutes after extubation
Incidence of endotracheal tube biting
Biting of the endotracheal tube; The investigator will observe whether the patient bites the endotracheal tube or not.
Time frame: During the time period from sevoflurane cessation until tracheal extubation, an average of 20 minutes
Hypoventilation after extubation (RR <8/min)
Hypoventilation defined as Respiratory Rate \<8/min
Time frame: During the time period from PACU admission until PACU discharge, an average of 40 minutes
Richmond Agitation-Sedation Scale (RASS) immediately after extubation and upon PACU arrival
The Richmond Agitation-Sedation Scale (range : +4 to -5)
Time frame: RASS will be assessed at two time points; (1) immediately after tracheal extubation, and (2) immediately after PACU arrival
Incidence of desaturation during PACU stay
Incidence of desaturation
Time frame: During the time period from PACU admission until PACU discharge, an average of 40 minutes
Hoarseness
Patients will be specifically asked about the existence of a hoarse voice
Time frame: During the time period from PACU admission until PACU discharge, an average of 40 minutes
Incidence and severity of sore throat
Incidence and severity of pain or irritation of the throat.
Time frame: During the time period from PACU admission until PACU discharge, an average of 40 minutes
Duration of PACU stay
Duration of PACU stay (minutes)
Time frame: During the time period from PACU admission until PACU discharge, an average of 40 minutes
Surgeon satisfaction regarding emergence process encompassing smoothness/safety/speed
Surgeon satisfaction regarding emergence process encompassing smoothness/safety/speed (0: totally unsatisfied, 10: totally satisfied)
Time frame: Immediately after the transfer of the patient from operating room to PACU
Incidence of awareness with recall
Patients will be specifically asked whether they experienced intraoperative consciousness, explicit recall of intraoperative events, or the emergence process.
Time frame: During the time period from PACU admission until PACU discharge, an average of 40 minutes
Pain score during PACU stay
pain score assessed by numeric rating scale; from 0 (no pain) to 10 (worst pain)
Time frame: During the time period from PACU admission until PACU discharge, an average of 40 minutes
Patient satisfaction score regarding emergence process
0: totally unsatisfied, 10: totally satisfied
Time frame: During the time period from PACU admission until PACU discharge, an average of 40 minutes
Incidence of Postoperative hematoma
hematoma formation
Time frame: After operation, through the hospitalization, an average of 3 days.
Incidence of wound dehiscence
dehiscence of the surgical wound
Time frame: After operation, through the hospitalization, an average of 3 days.
reoperation
reoperation of thyroid surgery
Time frame: After operation, through the hospitalization, an average of 3 days.
Oxygen Reserve Index
Index of the patient's oxygen reserve, with a unit-less scale between 0.00 and 1.00.
Time frame: During the period from sevoflurane cessation until PACU discharge, an average of 1 hour
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