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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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) |
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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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| ID | Term |
|---|---|
| C000629870 | Esketamine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| 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; |
|
| 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
| 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 |
| 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) |