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

NCT07641673 | Not Yet Recruiting DMC

• 1 other identifier: YX2026-095(F1)
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroidectomy; Coughing Reflex

Outcome Measures

Primary Outcomes (1)

• Incidence of coughing during tracheal extubation

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

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

Secondary Outcomes (34)

• Severity of coughing during tracheal extubation

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

• Agitation score during tube removal

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

• Blood pressure

  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

  5 minutes after intubation and at the end of the surgery.

• Intraoperative use rate and dosage of vasoactive drugs

  Intraoperative (From the induction period to the end of anesthesia)

Study Arms (3)

ESK iv group

EXPERIMENTAL

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: Esketamine（iv）

ESK spray group

EXPERIMENTAL

During anesthesia induction, intravenously inject an equal amount of normal saline. 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: ESK spray

CON group

PLACEBO COMPARATOR

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.

Drug: Normal Saline

Interventions

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 iv group

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).

ESK spray group

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.

CON group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Second Hospital of Anhui Medical University: lead

Study Sites (1)

Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Yun Wu

CONTACT

8613865958254; wuyunanyi@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Anesthesiology

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)