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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe Second Hospital of Anhui Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Esketamine(iv)

    Drug

    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.

  • ESK spray

    Drug

    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).

  • Normal Saline

    Drug

    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.

Treatment groups

186 Participants
are divided into 3 treatment groups
Group A: ESK iv groupExperimental treatment 1 intervention
Group B: ESK spray groupExperimental treatment 1 intervention
Group C: CON groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of coughing during tracheal extubation

0=None; 0 = Did not occur; 1 = Occurred;

Time frame
Perioperative (From the awakening period to immediately after tracheal extubation)

Secondary outcomes

1

Severity of coughing during 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.

Time frame
Perioperative (From the awakening period to immediately after tracheal extubation)
2

Agitation score during tube removal

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.

Time frame
Perioperative (From the awakening period to immediately after tracheal extubation)
3

Blood pressure

Baseline , post-induction, 1 minute after intubation, at the end of the surgery, 1 minute after extubation, and 5 minutes after extubation.

Time frame
Perioperative (From the induction period until 5 minutes after the completion of surgery)
4

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.

Other outcomes

Sponsors and contacts

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