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

NCT07625826 | Not Yet Recruiting DMC

• 1 other identifier: YX2026-124
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coughing Reflex; Thyroidectomy

Outcome Measures

Primary Outcomes (1)

• Incidence of coughing during tracheal extubation

  2 point scales; 0=None; 0 = Did not occur; 1 = Occurred;

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

Secondary Outcomes (33)

• 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

  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 (2)

ESK iv group

EXPERIMENTAL

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.

Drug: Esketamine

CON group

PLACEBO COMPARATOR

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;

Drug: Normal Saline

Interventions

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.

ESK iv group

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;

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 elective open thyroid surgery
• 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

Esketamine; 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 20, 2026
• First Posted: June 4, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)