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

7. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

186

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Arzneimittel: 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.
Experimental: 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).
Arzneimittel: 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).
Placebo-Komparator: 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.
Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of coughing during tracheal extubation
Zeitfenster: 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)

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

The Second Hospital of Anhui Medical University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. Mai 2027

Studienabschluss (Geschätzt)

1. September 2027

Studienanmeldedaten

Zuerst eingereicht

22. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Juni 2026

Zuerst gepostet (Tatsächlich)

11. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Juni 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • YX2026-095(F1)

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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