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The Effect of Esketamine on Cough Reflex During Tracheal Extubation in Patients Undergoing Non-inflatable Transoral Endoscopic Thyroid Surgery

7. června 2026 aktualizováno: Yun Wu, The Second Hospital of Anhui Medical University

The Effect of Esketamine on Cough Reflex During Tracheal Extubation in Patients Undergoing Non-inflatable Transoral Endoscopic Thyroid Surgery: A Randomized Controlled Study.

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

186

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Čína
    • Anhui
      • Hefei, Anhui, Čína
        • Second Affiliated Hospital of Anhui Medical University
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Patients scheduled for endotracheal intubation-free thyroid surgery under oral endoscopy
  • 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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: ESK iv group
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.
Lék: Esketamine（iv）
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.
Experimentální: ESK spray group
During anesthesia induction, intravenously inject an equal amount of normal saline. Once muscle relaxation is achieved, under direct laryngoscopic visualization, spray esketamine at the supraglottic, glottic, and subglottic levels: 3 ml (0.5 mg/kg).
Lék: ESK spray
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).
Komparátor placeba: CON group
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.
Lék: Normal Saline
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Incidence of coughing during tracheal extubation
Časové okno: Perioperative (From the awakening period to immediately after tracheal extubation)
0=None; 0 = Did not occur; 1 = Occurred;
Perioperative (From the awakening period to immediately after tracheal extubation)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Postoperative analgesic dosage
Časové okno: Within day 2 after surgery
Within day 2 after surgery
Intraoperative doses of propofol
Časové okno: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative (From the induction period to the end of anesthesia)
Intraoperative doses of remifentanil
Časové okno: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative (From the induction period to the end of anesthesia)
Intraoperative doses of Non-Steroidal Anti-Inflammatory Drugs(NSAIDs)
Časové okno: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative (From the induction period to the end of anesthesia)
Intraoperative doses of sufentanil
Časové okno: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative (From the induction period to the end of anesthesia)
Intraoperative fluid volume
Časové okno: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative (From the induction period to the end of anesthesia)
Intraoperative blood loss
Časové okno: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative (From the induction period to the end of anesthesia)
Postoperative time to ambulation
Časové okno: Perioperative (From the operating room to discharge)
Perioperative (From the operating room to discharge)
Length of postoperative hospital stay
Časové okno: Perioperative (From the operating room to discharge)
Perioperative (From the operating room to discharge)
Postoperative time to first water intake
Časové okno: Perioperative (Time from returning to the ward to the first drink of water)
Perioperative (Time from returning to the ward to the first drink of water)
Severity of coughing during tracheal extubation
Časové okno: Perioperative (From the awakening period to immediately after 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.
Perioperative (From the awakening period to immediately after tracheal extubation)
Agitation score during tube removal
Časové okno: Perioperative (From the awakening period to immediately after tracheal extubation)
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.
Perioperative (From the awakening period to immediately after tracheal extubation)
Blood pressure
Časové okno: Perioperative (From the induction period until 5 minutes after the completion of surgery)
Baseline , post-induction, 1 minute after intubation, at the end of the surgery, 1 minute after extubation, and 5 minutes after extubation.
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
Časové okno: 5 minutes after intubation and at the end of the surgery.
5 minutes after intubation and at the end of the surgery.
Intraoperative use rate and dosage of vasoactive drugs
Časové okno: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative (From the induction period to the end of anesthesia)
Sore throat score
Časové okno: Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively.
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.
Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively.
Surgical area pain scores
Časové okno: Postoperative 24 hours and 48 hours.
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.
Postoperative 24 hours and 48 hours.
Incidence of adverse reactions
Časové okno: Within 48 hours after surgery
Within 48 hours after surgery
Postoperative nausea and vomiting(PONV) score
Časové okno: Within 48 hours 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
Within 48 hours after surgery.
Postoperative time to first food
Časové okno: Perioperative (Time from returning to the ward to the first food)
Perioperative (Time from returning to the ward to the first food)
Upper Aerodigestive Symptoms After Thyroidectomy (UADS) questionnaire score
Časové okno: One month after surgery

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.
One month after surgery
Heart rate
Časové okno: From the induction period until 5 minutes after the completion of surgery.
Baseline, post-induction, 1 minute after intubation, at the end of the surgery, 1 minute after extubation, and 5 minutes after extubation.
From the induction period until 5 minutes after the completion of surgery.
Oxygen saturation
Časové okno: Intraoperative (From the induction period until 5 minutes after the completion of surgery)
Baseline , post-induction, 1 minute after intubation, at the end of the surgery, 1 minute after extubation, and 5 minutes after extubation.
Intraoperative (From the induction period until 5 minutes after the completion of surgery)
Anesthesia time
Časové okno: Time from induction to discontinuation of anesthetic agents.
Time from induction to discontinuation of anesthetic agents.
Surgery time
Časové okno: From the start of surgery to the end of surgery.
From the start of surgery to the end of surgery.
Endotracheal tube indwelling time
Časové okno: Perioperative (Time from intubation to extubation)
Perioperative (Time from intubation to extubation)
Awakening time
Časové okno: Perioperative (Stop the anesthesia drug injection until awakening time)
Perioperative (Stop the anesthesia drug injection until awakening time)
Extubation time
Časové okno: Perioperative (The time from discontinuation of anesthetic drugs to extubation)
Perioperative (The time from discontinuation of anesthetic drugs to extubation)
Post-anesthesia care unit (PACU) stay time
Časové okno: Perioperative (Duration from entering the PACU to leaving the PACU)
Perioperative (Duration from entering the PACU to leaving the PACU)
Hoarseness scores
Časové okno: Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively.
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.
Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively.
Sleep scores
Časové okno: Postoperative 24 hours and 48 hours.
1 = Good sleep; 2 = Restless sleep; 3 = Dreamy sleep; 4 = Insomnia; The higher the score, the poorer the sleep.
Postoperative 24 hours and 48 hours.
Numbness scores
Časové okno: Postoperative 24h and 48h.
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.
Postoperative 24h and 48h.
PACU RASS score
Časové okno: 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
Perioperative (Record once every ten minutes from the time of entering the post-anesthesia care unit until leaving the recovery room)
Postoperative analgesic dosage
Časové okno: Within 48 hours after surgery
Within 48 hours after surgery

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

The Second Hospital of Anhui Medical University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

1. května 2027

Dokončení studie (Odhadovaný)

1. září 2027

Termíny zápisu do studia

První předloženo

22. května 2026

První předloženo, které splnilo kritéria kontroly kvality

7. června 2026

První zveřejněno (Aktuální)

11. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

7. června 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • YX2026-095(F1)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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