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Not yet recruiting NCT07641673

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

No phase Interventional Thyroidectomy Coughing Reflex

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Esketamine（iv）, ESK spray, Normal Saline.
Who it may be relevant to
Registry conditions: Thyroidectomy, Coughing Reflex. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Effect of Esketamine on Cough Reflex During Tracheal Extubation in Patients Undergoing Non-inflatable Transoral Endoscopic Thyroid Surgery: A Randomized Controlled Study.

Overview

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.

Interventions

  • Drug 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.
  • Drug 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).
  • Drug 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.

Primary outcome measures

  • Incidence of coughing during tracheal extubation [Time frame: Perioperative (From the awakening period to immediately after tracheal extubation)]
Secondary outcome measures (12)
  • Severity of coughing during tracheal extubation [Time frame: Perioperative (From the awakening period to immediately after tracheal extubation)]
  • Agitation score during tube removal [Time frame: Perioperative (From the awakening period to immediately after tracheal extubation)]
  • Blood pressure [Time frame: 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 [Time frame: 5 minutes after intubation and at the end of the surgery.]
  • Intraoperative use rate and dosage of vasoactive drugs [Time frame: Intraoperative (From the induction period to the end of anesthesia)]
  • Intraoperative doses of sufentanil [Time frame: Intraoperative (From the induction period to the end of anesthesia)]
  • Intraoperative fluid volume [Time frame: Intraoperative (From the induction period to the end of anesthesia)]
  • Sore throat score [Time frame: Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively.]
  • Surgical area pain scores [Time frame: Postoperative 24 hours and 48 hours.]
  • Incidence of adverse reactions [Time frame: Within 48 hours after surgery]
  • Postoperative nausea and vomiting(PONV) score [Time frame: Within 48 hours after surgery.]
  • Postoperative analgesic dosage [Time frame: Within day 2 after surgery]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Second Affiliated Hospital of Anhui Medical University — Hefei

Identifiers

NCT: NCT07641673 · YX2026-095(F1)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗