The Effect of Esketamine on Cough Reflex During Tracheal Extubation in Patients Undergoing Open Thyroid Surgery

Study arms

• Experimental
  ESK iv group

  After anesthesia induction, continue to administer esketamine by infusion at 0.1 mg/kg/h during the maintenance phase of anesthesia, and stop the infusion of esketamine during suturing.

  Drug: Esketamine

• Placebo comparator
  CON group

  After anesthetic induction, an equal amount of saline is continuously infused by pump during the maintenance phase of anesthesia, and the saline infusion is stopped during suturing;

  Drug: Normal Saline

Interventions

• DrugEsketamine

  After anesthesia induction, continue to administer esketamine by infusion at 0.1 mg/kg/h during the maintenance phase of anesthesia, and stop the infusion of esketamine during suturing.

• DrugNormal Saline

  After anesthetic induction, an equal amount of saline is continuously infused by pump during the maintenance phase of anesthesia, and the saline infusion is stopped during suturing;

Primary outcomes

1. Incidence of coughing during tracheal extubation

   2 point scales; 0=None; 0 = Did not occur; 1 = Occurred;

   Time frame: perioperative (From the awakening period to immediately after tracheal extubation)

Secondary outcomes

1. Severity of coughing during tracheal extubation

   4 grade scales; 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)

2. Agitation score during tube removal

   3-level scale; 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)

3. Blood pressure

   Baseline, post-induction, 1 minute after intubation, during suturing, at the end of surgery, 1 minute after extubation, 5 minutes after extubation

   Time frame: From the induction period until 5 minutes after the completion of surgery

4. 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

5. Intraoperative use rate and dosage of vasoactive drugs

   Time frame: intraoperative (From the induction period to the end of anesthesia)

6. Sore throat score

   4-point scales; 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

7. Hoarseness scores

   4-point 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

8. 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 day 1 and day 2

9. Incidence of adverse reactions within 48 hours postoperatively

   Time frame: Within day 2 after surgery

10. 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 day 2 after surgery

11. Postoperative analgesic dosage

    Time frame: Within day 2 after surgery

12. Postoperative time to first food

    Time frame: perioperative (Time from returning to the ward to the first food)

13. 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: Three month after surgery

14. Heart rate

    Baseline, post-induction, 1 minute after intubation, during suturing, at the end of surgery, 1 minute after extubation, 5 minutes after extubation

    Time frame: Time Frame: From the induction period until 5 minutes after the completion of surgery

15. Oxygen saturation

    Baseline, post-induction, 1 minute after intubation, during suturing, at the end of surgery, 1 minute after extubation, 5 minutes after extubation

    Time frame: Time Frame: From the induction period until 5 minutes after the completion of surgery

16. Anesthesia time

    Time frame: perioperative (Time from induction to discontinuation of anesthetic agents)

17. Surgery time

    Time frame: From the start of surgery to the end of surgery

18. Extubation time

    Time frame: perioperative (The time from discontinuation of anesthetic drugs to extubation)

19. Duration of tracheal tube placement

    Time frame: perioperative (Time from intubation to )

20. Awakening time

    Time frame: perioperative (Stop the anesthesia drug injection until awakening time)

21. Post-anesthesia care unit (PACU) stay time

    Time frame: perioperative (Duration from entering the PACU to leaving the PACU)

22. 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.)

23. Intraoperative doses of propofol

    Time frame: Intraoperative (From the induction period to the end of anesthesia)

24. Intraoperative doses of remifentanil

    Time frame: Intraoperative (From the induction period to the end of anesthesia)

25. Intraoperative doses of Non-Steroidal Anti-Inflammatory Drugs(NSAIDs)

    Time frame: Intraoperative (From the induction period to the end of anesthesia)

26. Intraoperative doses of sufentanil

    Time frame: Intraoperative (From the induction period to the end of anesthesia)

27. Intraoperative fluid volume

    Time frame: Intraoperative (From the induction period to the end of anesthesia)

28. Intraoperative blood loss

    Time frame: Intraoperative (From the induction period to the end of anesthesia)

29. Sleep scores

    4 point 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

30. Antiemetic drug dosage

    Time frame: Within day 2 after surgery

31. Postoperative time to ambulation

    Time frame: Perioperative (From the operating room to discharge)

32. Length of postoperative hospital stay

    Time frame: Perioperative (From the operating room to discharge)

33. Postoperative time to first water intake

    Time frame: Perioperative (Time from returning to the ward to the first drink of water)

Individual participant data

Plan to share: No