The Effect of Esketamine on Cough Reflex During Tracheal Extubation in Patients Undergoing Open Thyroid Surgery
3 giugno 2026 aggiornato da: Yun Wu, The Second Hospital of Anhui Medical University
The Effect of Esketamine on Cough Reflex During Tracheal Extubation in Patients Undergoing Open Thyroid Surgery: A Randomized Controlled Study
This study intends to conduct a prospective randomized controlled trial to implement esketamine-assisted anesthesia in patients undergoing open thyroidectomy, in order to observe the effect of esketamine on coughing during extubation in thyroidectomy patients.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
136
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Yun Wu
- Numero di telefono: 8613865958254
- Email: wuyunanyi@163.com
Luoghi di studio
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Anhui
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Hefei, Anhui, Cina
- Second Affiliated hospital of Anhui Medical University
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- Patients scheduled for elective open thyroid surgery
- 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)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: ESK iv group
After anesthesia induction, continue to administer esketamine by infusion at 0.1 mg/kg/h during the maintenance phase of anesthesia, and stop the infusion of esketamine during suturing.
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After anesthesia induction, continue to administer esketamine by infusion at 0.1 mg/kg/h during the maintenance phase of anesthesia, and stop the infusion of esketamine during suturing.
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Comparatore placebo: CON group
After anesthetic induction, an equal amount of saline is continuously infused by pump during the maintenance phase of anesthesia, and the saline infusion is stopped during suturing;
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After anesthetic induction, an equal amount of saline is continuously infused by pump during the maintenance phase of anesthesia, and the saline infusion is stopped during suturing;
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Incidence of coughing during tracheal extubation
Lasso di tempo: perioperative (From the awakening period to immediately after tracheal extubation)
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2 point scales; 0=None; 0 = Did not occur; 1 = Occurred;
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perioperative (From the awakening period to immediately after tracheal extubation)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Severity of coughing during tracheal extubation
Lasso di tempo: perioperative (From the awakening period to immediately after tracheal extubation)
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4 grade scales; 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
Lasso di tempo: perioperative (From the awakening period to immediately after tracheal extubation)
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3-level scale; 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
Lasso di tempo: From the induction period until 5 minutes after the completion of surgery
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Baseline, post-induction, 1 minute after intubation, during suturing, at the end of surgery, 1 minute after extubation, 5 minutes after extubation
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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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively
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4-point scales; 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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Hoarseness scores
Lasso di tempo: Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively
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4-point scores; 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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Surgical area pain scores
Lasso di tempo: Postoperative day 1 and day 2
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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 day 1 and day 2
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Incidence of adverse reactions within 48 hours postoperatively
Lasso di tempo: Within day 2 after surgery
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Within day 2 after surgery
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Postoperative nausea and vomiting(PONV) score
Lasso di tempo: Within day 2 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 |
Within day 2 after surgery
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Postoperative analgesic dosage
Lasso di tempo: Within day 2 after surgery
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Within day 2 after surgery
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Postoperative time to first food
Lasso di tempo: 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
Lasso di tempo: Three 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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Three month after surgery
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Heart rate
Lasso di tempo: Time Frame: From the induction period until 5 minutes after the completion of surgery
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Baseline, post-induction, 1 minute after intubation, during suturing, at the end of surgery, 1 minute after extubation, 5 minutes after extubation
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Time Frame: From the induction period until 5 minutes after the completion of surgery
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Oxygen saturation
Lasso di tempo: Time Frame: From the induction period until 5 minutes after the completion of surgery
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Baseline, post-induction, 1 minute after intubation, during suturing, at the end of surgery, 1 minute after extubation, 5 minutes after extubation
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Time Frame: From the induction period until 5 minutes after the completion of surgery
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Anesthesia time
Lasso di tempo: perioperative (Time from induction to discontinuation of anesthetic agents)
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perioperative (Time from induction to discontinuation of anesthetic agents)
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Surgery time
Lasso di tempo: 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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Extubation time
Lasso di tempo: 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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Duration of tracheal tube placement
Lasso di tempo: perioperative (Time from intubation to )
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perioperative (Time from intubation to )
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Awakening time
Lasso di tempo: 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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Post-anesthesia care unit (PACU) stay time
Lasso di tempo: 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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PACU RASS score
Lasso di tempo: 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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Intraoperative doses of propofol
Lasso di tempo: 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 doses of remifentanil
Lasso di tempo: 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 doses of Non-Steroidal Anti-Inflammatory Drugs(NSAIDs)
Lasso di tempo: 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 doses of sufentanil
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Sleep scores
Lasso di tempo: Postoperative 24 hours and 48 hours
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4 point scores; 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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Antiemetic drug dosage
Lasso di tempo: Within day 2 after surgery
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Within day 2 after surgery
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Postoperative time to ambulation
Lasso di tempo: Perioperative (From the operating room to discharge)
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Perioperative (From the operating room to discharge)
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Length of postoperative hospital stay
Lasso di tempo: Perioperative (From the operating room to discharge)
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Perioperative (From the operating room to discharge)
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Postoperative time to first water intake
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 giugno 2026
Completamento primario (Stimato)
1 maggio 2027
Completamento dello studio (Stimato)
1 settembre 2027
Date di iscrizione allo studio
Primo inviato
20 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
3 giugno 2026
Primo Inserito (Effettivo)
4 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
4 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 giugno 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- YX2026-124
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .