Coughing Reflex, Thyroidectomy
Conditions
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.
Interventions
DRUGEsketamine（iv）
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.
DRUGESK spray
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).
DRUGNormal Saline
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.
Sponsors
The Second Hospital of Anhui Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of coughing during tracheal extubation | Perioperative (From the awakening period to immediately after tracheal extubation) | 0=None; 0 = Did not occur; 1 = Occurred; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of coughing during tracheal extubation | Perioperative (From the awakening period to immediately after 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. |
| Agitation score during tube removal | Perioperative (From the awakening period to immediately after tracheal extubation) | 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. |
| Blood pressure | Perioperative (From the induction period until 5 minutes after the completion of surgery) | Baseline , post-induction, 1 minute after intubation, at the end of the surgery, 1 minute after extubation, and 5 minutes after extubation. |
| 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) | — |
| 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) | — |
| Sore throat score | Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively. | 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. |
| Surgical area pain scores | Postoperative 24 hours and 48 hours. | 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. |
| Incidence of adverse reactions | Within 48 hours after surgery | — |
| Postoperative nausea and vomiting(PONV) score | Within 48 hours after surgery. | 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 |
| 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 | One month after surgery | Upper Aerodigestive Symptoms After Thyroidectomy Questionnaire; Instructions: 0=No problem, 1=Minor, 2=Moderate, 3=Major. Voice symptoms 1. Vocal fatigue 2. Difficulty speaking loudly 3. Roughness 4. Voice in low pitch 5. Can"t speak in high pitch 6. Voice in high pitch Swallowing/pharyngeal symptoms 7. Burning during swallowing 8. Pharyngeal bolus 9. Pain during deglutition 10. Pharyngeal pain 11. Choking 12. Dry throat 13. Discomfort during swallowing 14. Throat clearing 15. Neck scar retraction during deglutition 16. Foreign body sensation in pharynx 17. Strangling sensation during swallowing 18. Coughing during swallowing 19. Foreign body in pharynx; The higher the score, the more severe it is. |
| Heart rate | From the induction period until 5 minutes after the completion of surgery. | Baseline, post-induction, 1 minute after intubation, at the end of the surgery, 1 minute after extubation, and 5 minutes after extubation. |
| Oxygen saturation | Intraoperative (From the induction period until 5 minutes after the completion of surgery) | Baseline , post-induction, 1 minute after intubation, at the end of the surgery, 1 minute after extubation, and 5 minutes after extubation. |
| 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 blood loss | Intraoperative (From the induction period to the end of anesthesia) | — |
| Anesthesia time | Time from induction to discontinuation of anesthetic agents. | — |
| Surgery time | From the start of surgery to the end of surgery. | — |
| Endotracheal tube indwelling time | Perioperative (Time from intubation to extubation) | — |
| Awakening time | Perioperative (Stop the anesthesia drug injection until awakening time) | — |
| Extubation time | Perioperative (The time from discontinuation of anesthetic drugs to extubation) | — |
| Post-anesthesia care unit (PACU) stay time | Perioperative (Duration from entering the PACU to leaving the PACU) | — |
| Hoarseness scores | Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively. | 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. |
| Sleep scores | Postoperative 24 hours and 48 hours. | 1 = Good sleep; 2 = Restless sleep; 3 = Dreamy sleep; 4 = Insomnia; The higher the score, the poorer the sleep. |
| Numbness scores | Postoperative 24h and 48h. | Numbness Score: 0 = None; 1-3: Mild numbness, occasionally perceived, does not affect daily activities; 4-6: Moderate numbness, persistent numbness with slight discomfort, affecting some eating/speaking; 7-10: Severe numbness, strong numbness or complete loss of sensation, severely affecting daily life. The higher the score, the greater the level of numbness. |
| PACU RASS score | Perioperative (Record once every ten minutes from the time of entering the post-anesthesia care unit until leaving the recovery room) | * 4: Combative * 3: Very agitated * 2: Agitated * 1: Restless 0: Alert and calm * 1: Drowsy * 2: Light sedation * 3: Moderate sedation * 4: Deep sedation * 5: Unarousable |
| Postoperative time to first water intake | Perioperative (Time from returning to the ward to the first drink of water) | — |
| Postoperative time to ambulation | Perioperative (From the operating room to discharge) | — |
| Length of postoperative hospital stay | Perioperative (From the operating room to discharge) | — |
Countries
China
Contacts
CONTACTYun Wu
Outcome results
None listed