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

The Effect of Esketamine on Cough Reflex During Tracheal Extubation in Patients Undergoing Open Thyroid Surgery: A Randomized Controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Thyroidectomy; Coughing Reflex
• Intervention / Treatment: Drug: Esketamine; Drug: Normal Saline

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yun Wu; Phone Number: 8613865958254; Email: wuyunanyi@163.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Second Affiliated hospital of Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients scheduled for elective open thyroid surgery
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESK iv group; 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; 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.
Placebo Comparator: CON group; 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; 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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	perioperative (From the awakening period to immediately after tracheal extubation)
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.	perioperative (From the awakening period to immediately after tracheal extubation)
Blood pressure	Baseline, post-induction, 1 minute after intubation, during suturing, at the end of surgery, 1 minute after extubation, 5 minutes after extubation	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)
Sore throat score	4-point scales; 0 = None; 1 = Mild, milder than a common cold; 2 = Moderate, like a sore throat from a common cold; 3 = Severe, more severe than a common cold; The higher the score, the greater the level of pain.	Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively
Hoarseness scores	4-point scores; 0 = None; 1 = Transient hoarseness occurs; 2 = Patient perceives hoarseness during visit; 3 = Hoarseness is clearly noticeable; The higher the score, the more severe the hoarseness.	Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively
Surgical area pain scores	Pain NRS scale score: 0 = no pain; 1-3 = mild pain; 4-6 = moderate pain; 7-10 = severe pain. The higher the score, the more severe the pain.	Postoperative day 1 and day 2
Incidence of adverse reactions within 48 hours postoperatively		Within day 2 after surgery
Postoperative nausea and vomiting(PONV) score	Vomiting: 0 = None; 1 = Once; 2 = Twice; 3 = Three times or more Nausea, does it affect daily life: 0 = None; 1 = Sometimes; 2 = Often; 3 = Always	Within day 2 after surgery
Postoperative analgesic dosage		Within day 2 after surgery
Postoperative time to first food		perioperative (Time from returning to the ward to the first food)
Upper Aerodigestive Symptoms After Thyroidectomy (UADS) questionnaire score	Upper Aerodigestive Symptoms After Thyroidectomy Questionnaire; Instructions: 0=No problem, 1=Minor, 2=Moderate, 3=Major. Voice symptoms; Vocal fatigue; Difficulty speaking loudly; Roughness; Voice in low pitch; Can"t speak in high pitch; Voice in high pitchSwallowing/pharyngeal symptoms; Burning during swallowing; Pharyngeal bolus; Pain during deglutition; Pharyngeal pain; Choking; Dry throat; Discomfort during swallowing; Throat clearing; Neck scar retraction during deglutition; Foreign body sensation in pharynx; Strangling sensation during swallowing; Coughing during swallowing; Foreign body in pharynx; The higher the score, the more severe it is.	Three month after surgery
Heart rate	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
Oxygen saturation	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
Anesthesia time		perioperative (Time from induction to discontinuation of anesthetic agents)
Surgery time		From the start of surgery to the end of surgery
Extubation time		perioperative (The time from discontinuation of anesthetic drugs to extubation)
Duration of tracheal tube placement		perioperative (Time from intubation to )
Awakening time		perioperative (Stop the anesthesia drug injection until awakening time)
Post-anesthesia care unit (PACU) stay time		perioperative (Duration from entering the PACU to leaving the PACU)
PACU RASS score	4: Combative; 3: Very agitated; 2: Agitated; 1: Restless 0: Alert and calm1: Drowsy2: Light sedation3: Moderate sedation4: Deep sedation5: Unarousable	perioperative (Record once every ten minutes from the time of entering the post-anesthesia care unit until leaving the recovery room.)
Intraoperative doses of propofol		Intraoperative (From the induction period to the end of anesthesia)
Intraoperative doses of remifentanil		Intraoperative (From the induction period to the end of anesthesia)
Intraoperative doses of Non-Steroidal Anti-Inflammatory Drugs(NSAIDs)		Intraoperative (From the induction period to the end of anesthesia)
Intraoperative doses of sufentanil		Intraoperative (From the induction period to the end of anesthesia)
Intraoperative fluid volume		Intraoperative (From the induction period to the end of anesthesia)
Intraoperative blood loss		Intraoperative (From the induction period to the end of anesthesia)
Sleep scores	4 point scores; 1 = Good sleep; 2 = Restless sleep; 3 = Dreamy sleep; 4 = Insomnia; The higher the score, the poorer the sleep.	Postoperative 24 hours and 48 hours
Antiemetic drug dosage		Within day 2 after surgery
Postoperative time to ambulation		Perioperative (From the operating room to discharge)
Length of postoperative hospital stay		Perioperative (From the operating room to discharge)
Postoperative time to first water intake		Perioperative (Time from returning to the ward to the first drink of water)

Collaborators and Investigators

• Sponsor: The Second Hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Esketamine; Saline Solution
• Other Study ID Numbers: YX2026-124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No