Thyroid Surgery
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPSV
Pressure support ventilation applied from the start of subcutaneous suture until extubation.
PROCEDUREIntermittent Manual Assistance
Volume-controlled mode during surgery, with intermittent manual assistance from the end of surgery until extubation.
PROCEDUREEEG-Guidance
Extubation criteria based on EEG findings:Zipper opening pattern observed in the spectrogram 95% spectral edge frequency (SEF) ≥ 23 Patient state index (PSI) ≥ 64
PROCEDUREObey Command
Extubation criteria include obeying commands (eye-opening or handgrip).
PROCEDURESpontaneous Respiration
Extubation criteria include: Tidal volume \> 5 ml/kg End-tidal carbon dioxide (ETCO2) \< 45 mmHg Spontaneous respiratory rate (RR) 10 to 20 breaths/min
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Patients, medical staff responsible for measuring outcome variables, surgeons, and nurses in the recovery room and wards will be blinded. This blinding approach ensures that both medical staff and patients remain unaware of the assigned group throughout the study.
Intervention model description
Prospective, single-blinded, parallel-group, randomized clinical study
Eligibility
Sex/Gender
ALL
Age
19 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients aged under 40 years who are scheduled to undergo thyroid surgery.
Exclusion criteria
* Patients scheduled for radical neck dissection * Patients scheduled for lymph node biopsy * Patients with an anticipated difficult airway * Patients experiencing difficulty during intubation * Patients with a fasting time not meeting institutional policy * Patients with a body mass index (BMI) greater than 30 kg/m² * Patients with sleep apnea * Pregnant or breastfeeding women * Patients unable to communicate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of emergence coughing | During the time period from sevoflurane cessation until 5 minutes after extubation | Incidence of emergence coughing (defined as coughing during the time period from sevoflurane off until 5 minutes after extubation) |
| Lowest SpO2 after emergence | During the time period from sevoflurane cessation until post-anesthesia care unit (PACU) discharge, an average of 1 hour | Lowest SpO2 after emergence (defined as the lowest SpO2 value during the time period from sevoflurane off to post-anesthesia care unit (PACU) discharge) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to leave operating room | During the time period from sevoflurane cessation until leaving operating room, an average of 30 minutes | Time from sevoflurane cessation until leaving operating room |
| Severity of Emergence coughing | During the time period from sevoflurane cessation until 5 minutes after extubation. | 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. |
| Incidence and severity of coughing during PACU stay | During the time period from PACU admission until PACU discharge, an average of 40 minutes | Incidence and severity of coughing during PACU stay evaluated using a modified 4-point Minogue scale. |
| Emergence time | During the time period from sevoflurane cessation until tracheal extubation, an average of 20 minutes | Time from sevoflurane cessation until tracheal extubation (minutes) |
| Incidence of endotracheal tube biting | During the time period from sevoflurane cessation until tracheal extubation, an average of 20 minutes | Biting of the endotracheal tube; The investigator will observe whether the patient bites the endotracheal tube or not. |
| Hypoventilation after extubation (RR <8/min) | During the time period from PACU admission until PACU discharge, an average of 40 minutes | Hypoventilation defined as Respiratory Rate \<8/min |
| Richmond Agitation-Sedation Scale (RASS) immediately after extubation and upon PACU arrival | RASS will be assessed at two time points; (1) immediately after tracheal extubation, and (2) immediately after PACU arrival | The Richmond Agitation-Sedation Scale (range : +4 to -5) |
| Incidence of desaturation during PACU stay | During the time period from PACU admission until PACU discharge, an average of 40 minutes | Incidence of desaturation |
| Hoarseness | During the time period from PACU admission until PACU discharge, an average of 40 minutes | Patients will be specifically asked about the existence of a hoarse voice |
| Blood pressure during emergence | during the time period from sevoflurane off until 5 minutes after extubation | systolic, diastolic, mean blood pressure (mmHg) |
| Duration of PACU stay | During the time period from PACU admission until PACU discharge, an average of 40 minutes | Duration of PACU stay (minutes) |
| Surgeon satisfaction regarding emergence process encompassing smoothness/safety/speed | Immediately after the transfer of the patient from operating room to PACU | Surgeon satisfaction regarding emergence process encompassing smoothness/safety/speed (0: totally unsatisfied, 10: totally satisfied) |
| Incidence of awareness with recall | During the time period from PACU admission until PACU discharge, an average of 40 minutes | Patients will be specifically asked whether they experienced intraoperative consciousness, explicit recall of intraoperative events, or the emergence process. |
| Pain score during PACU stay | During the time period from PACU admission until PACU discharge, an average of 40 minutes | pain score assessed by numeric rating scale; from 0 (no pain) to 10 (worst pain) |
| Patient satisfaction score regarding emergence process | During the time period from PACU admission until PACU discharge, an average of 40 minutes | 0: totally unsatisfied, 10: totally satisfied |
| Incidence of Postoperative hematoma | After operation, through the hospitalization, an average of 3 days. | hematoma formation |
| Incidence of wound dehiscence | After operation, through the hospitalization, an average of 3 days. | dehiscence of the surgical wound |
| reoperation | After operation, through the hospitalization, an average of 3 days. | reoperation of thyroid surgery |
| Oxygen Reserve Index | During the period from sevoflurane cessation until PACU discharge, an average of 1 hour | Index of the patient's oxygen reserve, with a unit-less scale between 0.00 and 1.00. |
| Incidence and severity of sore throat | During the time period from PACU admission until PACU discharge, an average of 40 minutes | Incidence and severity of pain or irritation of the throat. |
| Heart rate during emergence | during the time period from sevoflurane off until 5 minutes after extubation | Heart rate (beats per minute) |
Countries
South Korea
Outcome results
None listed