This study intends to implement esketamine-assisted anesthesia in patients undergoing non-inflatable transoral endoscopic thyroidectomy through a prospective randomized controlled trial, in order to observe the effect of esketamine on coughing during extubation in thyroidectomy patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
186
During anesthesia induction, administer esketamine intravenously at 0.5 mg/kg. Once muscle relaxation is achieved, under direct laryngoscopic visualization, spray physiological saline (3 ml) above the glottis, at the glottis, and below the glottis.
During anesthesia induction, Once muscle relaxation is achieved, under direct laryngoscopic visualization, spray esketamine at the supraglottic, glottic, and subglottic levels: 3 ml (0.5 mg/kg).
During anesthesia induction, intravenous injection of an equal amount of normal saline is administered. After achieving muscle relaxation, under direct laryngoscopic view, spray normal saline over the supraglottic, glottic, and subglottic areas: 3 ml.
Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Incidence of coughing during tracheal extubation
0=None; 0 = Did not occur; 1 = Occurred;
Time frame: Perioperative (From the awakening period to immediately after tracheal extubation)
Severity of coughing during tracheal extubation
Grade 0: No choking cough; Grade 1: Single cough episode, considered mild choking cough; Grade 2: Intermittent cough, lasting less than 5 seconds, considered moderate choking cough; Grade 3: Continuous severe cough, lasting more than 5 seconds, considered severe choking cough; The higher the degree, the worse it is.
Time frame: Perioperative (From the awakening period to immediately after tracheal extubation)
Agitation score during tube removal
1: Awake and calm; 2: Mild agitation but can be comforted; 3: Moderate agitation, difficult to comfort; 4: Severe agitation, cannot be comforted; The higher the degree, the worse the situation.
Time frame: Perioperative (From the awakening period to immediately after tracheal extubation)
Blood pressure
Baseline , post-induction, 1 minute after intubation, at the end of the surgery, 1 minute after extubation, and 5 minutes after extubation.
Time frame: Perioperative (From the induction period until 5 minutes after the completion of surgery)
Airway pressure 5 minutes after intubation and at the end of surgery
Time frame: 5 minutes after intubation and at the end of the surgery.
Intraoperative use rate and dosage of vasoactive drugs
Time frame: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative doses of sufentanil
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Time frame: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative fluid volume
Time frame: Intraoperative (From the induction period to the end of anesthesia)
Sore throat score
0 = None; 1 = Mild, milder than a common cold; 2 = Moderate, like a sore throat from a common cold; 3 = Severe, more severe than a common cold; The higher the score, the greater the level of pain.
Time frame: Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively.
Surgical area pain scores
Pain NRS scale score: 0 = no pain; 1-3 = mild pain; 4-6 = moderate pain; 7-10 = severe pain; The higher the score, the more severe the pain.
Time frame: Postoperative 24 hours and 48 hours.
Incidence of adverse reactions
Time frame: Within 48 hours after surgery
Postoperative nausea and vomiting(PONV) score
Vomiting: 0 = None; 1 = Once; 2 = Twice; 3 = Three times or more Nausea, does it affect daily life: 0 = None; 1 = Sometimes; 2 = Often; 3 = Always
Time frame: Within 48 hours after surgery.
Postoperative analgesic dosage
Time frame: Within day 2 after surgery
Postoperative time to first food
Time frame: Perioperative (Time from returning to the ward to the first food)
Upper Aerodigestive Symptoms After Thyroidectomy (UADS) questionnaire score
Upper Aerodigestive Symptoms After Thyroidectomy Questionnaire; Instructions: 0=No problem, 1=Minor, 2=Moderate, 3=Major. Voice symptoms 1. Vocal fatigue 2. Difficulty speaking loudly 3. Roughness 4. Voice in low pitch 5. Can"t speak in high pitch 6. Voice in high pitch Swallowing/pharyngeal symptoms 7. Burning during swallowing 8. Pharyngeal bolus 9. Pain during deglutition 10. Pharyngeal pain 11. Choking 12. Dry throat 13. Discomfort during swallowing 14. Throat clearing 15. Neck scar retraction during deglutition 16. Foreign body sensation in pharynx 17. Strangling sensation during swallowing 18. Coughing during swallowing 19. Foreign body in pharynx; The higher the score, the more severe it is.
Time frame: One month after surgery
Heart rate
Baseline, post-induction, 1 minute after intubation, at the end of the surgery, 1 minute after extubation, and 5 minutes after extubation.
Time frame: From the induction period until 5 minutes after the completion of surgery.
Oxygen saturation
Baseline , post-induction, 1 minute after intubation, at the end of the surgery, 1 minute after extubation, and 5 minutes after extubation.
Time frame: Intraoperative (From the induction period until 5 minutes after the completion of surgery)
Intraoperative doses of propofol
Time frame: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative doses of remifentanil
Time frame: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative doses of Non-Steroidal Anti-Inflammatory Drugs(NSAIDs)
Time frame: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative blood loss
Time frame: Intraoperative (From the induction period to the end of anesthesia)
Anesthesia time
Time frame: Time from induction to discontinuation of anesthetic agents.
Surgery time
Time frame: From the start of surgery to the end of surgery.
Endotracheal tube indwelling time
Time frame: Perioperative (Time from intubation to extubation)
Awakening time
Time frame: Perioperative (Stop the anesthesia drug injection until awakening time)
Extubation time
Time frame: Perioperative (The time from discontinuation of anesthetic drugs to extubation)
Post-anesthesia care unit (PACU) stay time
Time frame: Perioperative (Duration from entering the PACU to leaving the PACU)
Hoarseness scores
0 = None; 1 = Transient hoarseness occurs; 2 = Patient perceives hoarseness during visit; 3 = Hoarseness is clearly noticeable; The higher the score, the more severe the hoarseness.
Time frame: Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively.
Sleep scores
1 = Good sleep; 2 = Restless sleep; 3 = Dreamy sleep; 4 = Insomnia; The higher the score, the poorer the sleep.
Time frame: Postoperative 24 hours and 48 hours.
Numbness scores
Numbness Score: 0 = None; 1-3: Mild numbness, occasionally perceived, does not affect daily activities; 4-6: Moderate numbness, persistent numbness with slight discomfort, affecting some eating/speaking; 7-10: Severe numbness, strong numbness or complete loss of sensation, severely affecting daily life. The higher the score, the greater the level of numbness.
Time frame: Postoperative 24h and 48h.
PACU RASS score
* 4: Combative * 3: Very agitated * 2: Agitated * 1: Restless 0: Alert and calm * 1: Drowsy * 2: Light sedation * 3: Moderate sedation * 4: Deep sedation * 5: Unarousable
Time frame: Perioperative (Record once every ten minutes from the time of entering the post-anesthesia care unit until leaving the recovery room)
Postoperative analgesic dosage
Time frame: Within 48 hours after surgery
Postoperative time to first water intake
Time frame: Perioperative (Time from returning to the ward to the first drink of water)
Postoperative time to ambulation
Time frame: Perioperative (From the operating room to discharge)
Length of postoperative hospital stay
Time frame: Perioperative (From the operating room to discharge)