The Effect of Esketamine on Cough Reflex During Tracheal Extubation in Patients Undergoing Open 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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients scheduled for elective open thyroid surgery

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

    Drug

    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.

  • Normal Saline

    Drug

    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;

Treatment groups

136 Participants
are divided into 2 treatment groups
Group A: ESK iv groupExperimental treatment 1 intervention
Group B: CON groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of coughing during tracheal extubation

2 point scales; 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

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.

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

Agitation score during tube removal

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.

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

Blood pressure

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

Time frame
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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