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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of coughing during tracheal extubation | 0=None; 0 = Did not occur; 1 = Occurred; | Perioperative (From the awakening period to immediately after tracheal extubation) |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of coughing during 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. | Perioperative (From the awakening period to immediately after tracheal extubation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yun Wu | Contact | 8613865958254 | wuyunanyi@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui | China |
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| 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). |
|
| 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. |
|
| Agitation score during tube removal | 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, at the end of the surgery, 1 minute after extubation, and 5 minutes after extubation. | 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) |
| 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 | 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. |
| 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 24 hours and 48 hours. |
| Incidence of adverse reactions | Within 48 hours 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 48 hours 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
| One month after surgery |
| Heart rate | Baseline, post-induction, 1 minute after intubation, at the end of the surgery, 1 minute after extubation, and 5 minutes after extubation. | From the induction period until 5 minutes after the completion of surgery. |
| Oxygen saturation | Baseline , post-induction, 1 minute after intubation, at the end of the surgery, 1 minute after extubation, and 5 minutes after extubation. | Intraoperative (From the induction period until 5 minutes after the completion of surgery) |
| 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 | 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. |
| Sleep 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. |
| Numbness scores | 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. | Postoperative 24h and 48h. |
| PACU RASS score |
| Perioperative (Record once every ten minutes from the time of entering the post-anesthesia care unit until leaving the recovery room) |
| Postoperative analgesic dosage | Within 48 hours after surgery |
| 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) |
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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