Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

7. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

186

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.
Eksperimentel: 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).
Medicin: 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.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of coughing during tracheal extubation
Tidsramme: 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)

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The Second Hospital of Anhui Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. maj 2027

Studieafslutning (Anslået)

1. september 2027

Datoer for studieregistrering

Først indsendt

22. maj 2026

Først indsendt, der opfyldte QC-kriterier

7. juni 2026

Først opslået (Faktiske)

11. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • YX2026-095(F1)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Esketamine（iv）

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Greece

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner