The Effect of Esketamine on Cough Reflex During Tracheal Extubation in Patients Undergoing Non-inflatable Transoral Endoscopic Thyroid Surgery
7. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
186
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Yun Wu
- Telefonnummer: 8613865958254
- E-post: wuyunanyi@163.com
Studiesteder
-
-
Anhui
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Hefei, Anhui, Kina
- Second Affiliated hospital of Anhui Medical University
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Ta kontakt med:
- Yun Wu
- Telefonnummer: 8613865958254
- E-post: wuyunanyi@163.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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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.
|
|
Eksperimentell: 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).
|
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).
|
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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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of coughing during tracheal extubation
Tidsramme: Perioperative (From the awakening period to immediately after tracheal extubation)
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0=None; 0 = Did not occur; 1 = Occurred;
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Perioperative (From the awakening period to immediately after tracheal extubation)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative analgesic dosage
Tidsramme: Within day 2 after surgery
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Within day 2 after surgery
|
|
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Intraoperative doses of propofol
Tidsramme: Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative (From the induction period to the end of anesthesia)
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|
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Intraoperative doses of remifentanil
Tidsramme: Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative (From the induction period to the end of anesthesia)
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|
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Intraoperative doses of Non-Steroidal Anti-Inflammatory Drugs(NSAIDs)
Tidsramme: Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative (From the induction period to the end of anesthesia)
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|
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Intraoperative doses of sufentanil
Tidsramme: Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative fluid volume
Tidsramme: Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative blood loss
Tidsramme: Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative (From the induction period to the end of anesthesia)
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|
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Postoperative time to ambulation
Tidsramme: Perioperative (From the operating room to discharge)
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Perioperative (From the operating room to discharge)
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|
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Length of postoperative hospital stay
Tidsramme: Perioperative (From the operating room to discharge)
|
Perioperative (From the operating room to discharge)
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Postoperative time to first water intake
Tidsramme: Perioperative (Time from returning to the ward to the first drink of water)
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Perioperative (Time from returning to the ward to the first drink of water)
|
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Severity of coughing during tracheal extubation
Tidsramme: Perioperative (From the awakening period to immediately after tracheal extubation)
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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.
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Perioperative (From the awakening period to immediately after tracheal extubation)
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Agitation score during tube removal
Tidsramme: Perioperative (From the awakening period to immediately after tracheal extubation)
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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.
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Perioperative (From the awakening period to immediately after tracheal extubation)
|
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Blood pressure
Tidsramme: Perioperative (From the induction period until 5 minutes after the completion of surgery)
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Baseline , post-induction, 1 minute after intubation, at the end of the surgery, 1 minute after extubation, and 5 minutes after extubation.
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Perioperative (From the induction period until 5 minutes after the completion of surgery)
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Airway pressure 5 minutes after intubation and at the end of surgery
Tidsramme: 5 minutes after intubation and at the end of the surgery.
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5 minutes after intubation and at the end of the surgery.
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Intraoperative use rate and dosage of vasoactive drugs
Tidsramme: Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative (From the induction period to the end of anesthesia)
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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.
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Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively.
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Surgical area pain scores
Tidsramme: Postoperative 24 hours and 48 hours.
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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.
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Postoperative 24 hours and 48 hours.
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Incidence of adverse reactions
Tidsramme: Within 48 hours after surgery
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Within 48 hours after surgery
|
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Postoperative nausea and vomiting(PONV) score
Tidsramme: Within 48 hours after surgery.
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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
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Within 48 hours after surgery.
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Postoperative time to first food
Tidsramme: Perioperative (Time from returning to the ward to the first food)
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Perioperative (Time from returning to the ward to the first food)
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Upper Aerodigestive Symptoms After Thyroidectomy (UADS) questionnaire score
Tidsramme: One month after surgery
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Upper Aerodigestive Symptoms After Thyroidectomy Questionnaire; Instructions: 0=No problem, 1=Minor, 2=Moderate, 3=Major. Voice symptoms
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One month after surgery
|
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Heart rate
Tidsramme: From the induction period until 5 minutes after the completion of surgery.
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Baseline, post-induction, 1 minute after intubation, at the end of the surgery, 1 minute after extubation, and 5 minutes after extubation.
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From the induction period until 5 minutes after the completion of surgery.
|
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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.
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Intraoperative (From the induction period until 5 minutes after the completion of surgery)
|
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Anesthesia time
Tidsramme: Time from induction to discontinuation of anesthetic agents.
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Time from induction to discontinuation of anesthetic agents.
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Surgery time
Tidsramme: From the start of surgery to the end of surgery.
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From the start of surgery to the end of surgery.
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Endotracheal tube indwelling time
Tidsramme: Perioperative (Time from intubation to extubation)
|
Perioperative (Time from intubation to extubation)
|
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Awakening time
Tidsramme: Perioperative (Stop the anesthesia drug injection until awakening time)
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Perioperative (Stop the anesthesia drug injection until awakening time)
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Extubation time
Tidsramme: Perioperative (The time from discontinuation of anesthetic drugs to extubation)
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Perioperative (The time from discontinuation of anesthetic drugs to extubation)
|
|
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Post-anesthesia care unit (PACU) stay time
Tidsramme: Perioperative (Duration from entering the PACU to leaving the PACU)
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Perioperative (Duration from entering the PACU to leaving the PACU)
|
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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.
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Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively.
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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.
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Postoperative 24 hours and 48 hours.
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Numbness scores
Tidsramme: Postoperative 24h and 48h.
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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.
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Postoperative 24h and 48h.
|
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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)
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Perioperative (Record once every ten minutes from the time of entering the post-anesthesia care unit until leaving the recovery room)
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Postoperative analgesic dosage
Tidsramme: Within 48 hours after surgery
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Within 48 hours after surgery
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Studer hoveddatoer
Studiestart (Antatt)
1. juni 2026
Primær fullføring (Antatt)
1. mai 2027
Studiet fullført (Antatt)
1. september 2027
Datoer for studieregistrering
Først innsendt
22. mai 2026
Først innsendt som oppfylte QC-kriteriene
7. juni 2026
Først lagt ut (Faktiske)
11. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. juni 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- YX2026-095(F1)
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