Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
NCT Number: NCT07641673
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Hefei, Anhui, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
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.
Time frame: Perioperative (From the awakening period to immediately after tracheal extubation)
0=None; 0 = Did not occur; 1 = Occurred;
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5 minutes after intubation and at the end of the surgery.
Time frame: Intraoperative (From the induction period to the end of anesthesia)
Time frame: Intraoperative (From the induction period to the end of anesthesia)
Time frame: Intraoperative (From the induction period to the end of anesthesia)
Time frame: 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.
Time frame: 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.
Time frame: Within 48 hours after surgery
Time frame: 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
Time frame: Within day 2 after surgery
Time frame: Perioperative (Time from returning to the ward to the first food)
Time frame: One month after surgery
Upper Aerodigestive Symptoms After Thyroidectomy Questionnaire; Instructions: 0=No problem, 1=Minor, 2=Moderate, 3=Major. Voice symptoms
Swallowing/pharyngeal symptoms
Time frame: 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.
Time frame: 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.
Time frame: Intraoperative (From the induction period to the end of anesthesia)
Time frame: Intraoperative (From the induction period to the end of anesthesia)
Time frame: Intraoperative (From the induction period to the end of anesthesia)
Time frame: Intraoperative (From the induction period to the end of anesthesia)
Time frame: Time from induction to discontinuation of anesthetic agents.
Time frame: From the start of surgery to the end of surgery.
Time frame: Perioperative (Time from intubation to extubation)
Time frame: Perioperative (Stop the anesthesia drug injection until awakening time)
Time frame: Perioperative (The time from discontinuation of anesthetic drugs to extubation)
Time frame: Perioperative (Duration from entering the PACU to leaving the PACU)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Perioperative (Record once every ten minutes from the time of entering the post-anesthesia care unit until leaving the recovery room)
Time frame: Within 48 hours after surgery
Time frame: Perioperative (Time from returning to the ward to the first drink of water)
Time frame: Perioperative (From the operating room to discharge)
Time frame: Perioperative (From the operating room to discharge)
Contact information is provided by the study sponsor or research team.
The Second Hospital of Anhui Medical University
Other
The Effect of Esketamine on Cough Reflex During Tracheal Extubation in Patients Undergoing Non-inflatable Transoral Endoscopic Thyroid Surgery: A Randomized Controlled Study.
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