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NCT Number: NCT07625826

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

This study intends to conduct a prospective randomized controlled trial to implement esketamine-assisted anesthesia in patients undergoing open thyroidectomy, in order to observe the effect of esketamine on coughing during extubation in thyroidectomy patients.

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Key information

Conditions

Thyroidectomy Coughing Reflex

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled for elective open thyroid surgery
  • ASA class I-II
  • Voluntarily participate in the study and sign the informed consent form

Exclusion criteria

  • Body Mass Index > 30 kg/m²
  • Patients with unstable ischemic cardiomyopathy, pulmonary hypertension, poorly controlled or untreated hypertension (arterial hypertension, resting systolic/diastolic blood pressure >180/100 mmHg)
  • Hepatic or renal dysfunction
  • History of oral, maxillofacial, neck, or airway surgery, or pathological structural alterations
  • Respiratory diseases (COPD, asthma, inflammation, chronic cough)
  • Patients with elevated intracranial pressure
  • Patients undergoing repeat surgery
  • History of allergy to the investigational drug used in the study
  • Patients with psychiatric disorders or alcohol abuse (daily ethanol intake ≥40 g, or having experienced alcohol withdrawal within the past 6 months, or unable to control alcohol consumption)

Treatment and study plan

Esketamine

Drug

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.

normal saline

Drug

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

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

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

Secondary outcomes

  1. Severity of coughing during tracheal extubation

    Time frame: perioperative (From the awakening period to immediately after 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.

  2. Agitation score during tube removal

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

    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.

  3. Blood pressure

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

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

  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

    Time frame: Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively

    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.

  7. Hoarseness scores

    Time frame: Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively

    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.

  8. Surgical area pain scores

    Time frame: Postoperative day 1 and day 2

    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.

  9. Incidence of adverse reactions within 48 hours postoperatively

    Time frame: Within day 2 after surgery

  10. Postoperative nausea and vomiting(PONV) score

    Time frame: Within day 2 after surgery

    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

  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

    Time frame: Three month after surgery

    Upper Aerodigestive Symptoms After Thyroidectomy Questionnaire; Instructions: 0=No problem, 1=Minor, 2=Moderate, 3=Major. Voice symptoms

    • Vocal fatigue
    • Difficulty speaking loudly
    • Roughness
    • Voice in low pitch
    • Can"t speak in high pitch
    • Voice in high pitch

    Swallowing/pharyngeal symptoms

    • Burning during swallowing
    • Pharyngeal bolus
    • Pain during deglutition
    • Pharyngeal pain
    • Choking
    • Dry throat
    • Discomfort during swallowing
    • Throat clearing
    • Neck scar retraction during deglutition
    • Foreign body sensation in pharynx
    • Strangling sensation during swallowing
    • Coughing during swallowing
    • Foreign body in pharynx; The higher the score, the more severe it is.

  14. Heart rate

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

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

  15. Oxygen saturation

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

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

  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

    Time frame: perioperative (Record once every ten minutes from the time of entering the post-anesthesia care unit until leaving the recovery room.)

    • 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

  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

    Time frame: Postoperative 24 hours and 48 hours

    4 point scores; 1 = Good sleep; 2 = Restless sleep; 3 = Dreamy sleep; 4 = Insomnia; The higher the score, the poorer the sleep.

  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)

Study contacts

Contact information is provided by the study sponsor or research team.

Yun Wu

CONTACT

[email protected]

8613865958254

Sponsors and collaborators

Lead sponsor

The Second Hospital of Anhui Medical University

Other

Registry information

Official study title

The Effect of Esketamine on Cough Reflex During Tracheal Extubation in Patients Undergoing Open Thyroid Surgery: A Randomized Controlled Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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