The Effect of Esketamine on Cough Reflex During Tracheal Extubation in Patients Undergoing Open Thyroid Surgery
3 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
136
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Yun Wu
- Telefonnummer: 8613865958254
- E-post: wuyunanyi@163.com
Studieorter
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Anhui
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Hefei, Anhui, Kina
- Second Affiliated hospital of Anhui Medical University
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Placebo-jämförare: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Incidence of coughing during tracheal extubation
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Severity of coughing during tracheal extubation
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Within day 2 after surgery
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Within day 2 after surgery
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Postoperative nausea and vomiting(PONV) score
Tidsram: 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
Tidsram: Within day 2 after surgery
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Within day 2 after surgery
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Postoperative time to first food
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: perioperative (Time from intubation to )
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perioperative (Time from intubation to )
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Awakening time
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Within day 2 after surgery
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Within day 2 after surgery
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Postoperative time to ambulation
Tidsram: 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
Tidsram: 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
Tidsram: 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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Studieavstämningsdatum
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Studera stora datum
Studiestart (Beräknad)
1 juni 2026
Primärt slutförande (Beräknad)
1 maj 2027
Avslutad studie (Beräknad)
1 september 2027
Studieregistreringsdatum
Först inskickad
20 maj 2026
Först inskickad som uppfyllde QC-kriterierna
3 juni 2026
Första postat (Faktisk)
4 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 juni 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- YX2026-124
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