Pressure Supporting Ventilation and EEG-guided Emergence for Free of Unwanted Complications
- Conditions
- Thyroid Surgery
- Interventions
- Procedure: Intermittent Manual AssistanceProcedure: PSVProcedure: EEG-GuidanceProcedure: Obey CommandProcedure: Spontaneous Respiration
- Registration Number
- NCT06165562
- Lead Sponsor
- Gangnam Severance Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Adult patients aged under 40 years who are scheduled to undergo thyroid surgery.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional Emergence group Intermittent Manual Assistance 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. Pressure Supporting Ventilation (PSV) and EEG-guided Emergence group EEG-Guidance 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 Pressure Supporting Ventilation (PSV) and EEG-guided Emergence group Spontaneous Respiration 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 Pressure Supporting Ventilation (PSV) and EEG-guided Emergence group PSV 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 Conventional Emergence group Obey Command 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. Conventional Emergence group Spontaneous Respiration 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.
- Primary Outcome Measures
Name Time Method 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)
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)
- Secondary Outcome Measures
Name Time Method 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.
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
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.
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)
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.
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)
Blood pressure during emergence during the time period from sevoflurane off until 5 minutes after extubation systolic, diastolic, mean blood pressure (mmHg)
Heart rate during emergence during the time period from sevoflurane off until 5 minutes after extubation Heart rate (beats per minute)
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
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)
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 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
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.
reoperation After operation, through the hospitalization, an average of 3 days. reoperation of thyroid surgery
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
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.
Trial Locations
- Locations (1)
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of