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

7 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

186

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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)

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: 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.
Eksperymentalny: 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).
Lek: 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).
Komparator placebo: 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.
Lek: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Incidence of coughing during tracheal extubation
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Postoperative analgesic dosage
Ramy czasowe: Within day 2 after surgery
Within day 2 after surgery
Intraoperative doses of propofol
Ramy czasowe: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative (From the induction period to the end of anesthesia)
Intraoperative doses of remifentanil
Ramy czasowe: 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)
Ramy czasowe: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative (From the induction period to the end of anesthesia)
Intraoperative doses of sufentanil
Ramy czasowe: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative (From the induction period to the end of anesthesia)
Intraoperative fluid volume
Ramy czasowe: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative (From the induction period to the end of anesthesia)
Intraoperative blood loss
Ramy czasowe: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative (From the induction period to the end of anesthesia)
Postoperative time to ambulation
Ramy czasowe: Perioperative (From the operating room to discharge)
Perioperative (From the operating room to discharge)
Length of postoperative hospital stay
Ramy czasowe: Perioperative (From the operating room to discharge)
Perioperative (From the operating room to discharge)
Postoperative time to first water intake
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative (From the induction period to the end of anesthesia)
Sore throat score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Within 48 hours after surgery
Within 48 hours after surgery
Postoperative nausea and vomiting(PONV) score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Time from induction to discontinuation of anesthetic agents.
Time from induction to discontinuation of anesthetic agents.
Surgery time
Ramy czasowe: From the start of surgery to the end of surgery.
From the start of surgery to the end of surgery.
Endotracheal tube indwelling time
Ramy czasowe: Perioperative (Time from intubation to extubation)
Perioperative (Time from intubation to extubation)
Awakening time
Ramy czasowe: Perioperative (Stop the anesthesia drug injection until awakening time)
Perioperative (Stop the anesthesia drug injection until awakening time)
Extubation time
Ramy czasowe: 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
Ramy czasowe: Perioperative (Duration from entering the PACU to leaving the PACU)
Perioperative (Duration from entering the PACU to leaving the PACU)
Hoarseness scores
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Within 48 hours after surgery
Within 48 hours after surgery

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

The Second Hospital of Anhui Medical University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 maja 2027

Ukończenie studiów (Szacowany)

1 września 2027

Daty rejestracji na studia

Pierwszy przesłany

22 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

11 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

11 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

7 czerwca 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • YX2026-095(F1)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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