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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Yun Wu
- 전화번호: 8613865958254
- 이메일: wuyunanyi@163.com
연구 장소
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Anhui
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Hefei, Anhui, 중국
- Second Affiliated Hospital of Anhui Medical University
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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. |
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. |
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위약 비교기: 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; |
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; |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of coughing during tracheal extubation
기간: perioperative (From the awakening period to immediately after tracheal extubation)
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2 point scales; 0=None; 0 = Did not occur; 1 = Occurred; |
perioperative (From the awakening period to immediately after tracheal extubation)
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Airway pressure 5 minutes after intubation and at the end of surgery
기간: 5 minutes after intubation and at the end of the surgery
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5 minutes after intubation and at the end of the surgery
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Intraoperative use rate and dosage of vasoactive drugs
기간: intraoperative (From the induction period to the end of anesthesia)
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intraoperative (From the induction period to the end of anesthesia)
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Incidence of adverse reactions within 48 hours postoperatively
기간: Within day 2 after surgery
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Within day 2 after surgery
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Postoperative analgesic dosage
기간: Within day 2 after surgery
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Within day 2 after surgery
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Postoperative time to first food
기간: perioperative (Time from returning to the ward to the first food)
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perioperative (Time from returning to the ward to the first food)
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Anesthesia time
기간: perioperative (Time from induction to discontinuation of anesthetic agents)
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perioperative (Time from induction to discontinuation of anesthetic agents)
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Surgery time
기간: From the start of surgery to the end of surgery
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From the start of surgery to the end of surgery
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Extubation time
기간: perioperative (The time from discontinuation of anesthetic drugs to extubation)
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perioperative (The time from discontinuation of anesthetic drugs to extubation)
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Duration of tracheal tube placement
기간: perioperative (Time from intubation to )
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perioperative (Time from intubation to )
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Awakening time
기간: perioperative (Stop the anesthesia drug injection until awakening time)
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perioperative (Stop the anesthesia drug injection until awakening time)
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Post-anesthesia care unit (PACU) stay time
기간: perioperative (Duration from entering the PACU to leaving the PACU)
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perioperative (Duration from entering the PACU to leaving the PACU)
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Intraoperative doses of propofol
기간: Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative doses of remifentanil
기간: Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative doses of Non-Steroidal Anti-Inflammatory Drugs(NSAIDs)
기간: Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative doses of sufentanil
기간: Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative fluid volume
기간: Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative blood loss
기간: Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative (From the induction period to the end of anesthesia)
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Antiemetic drug dosage
기간: Within day 2 after surgery
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Within day 2 after surgery
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Postoperative time to ambulation
기간: Perioperative (From the operating room to discharge)
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Perioperative (From the operating room to discharge)
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Length of postoperative hospital stay
기간: Perioperative (From the operating room to discharge)
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Perioperative (From the operating room to discharge)
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Postoperative time to first water intake
기간: Perioperative (Time from returning to the ward to the first drink of water)
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Perioperative (Time from returning to the ward to the first drink of water)
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Severity of coughing during tracheal extubation
기간: perioperative (From the awakening period to immediately after tracheal extubation)
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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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Agitation score during tube removal
기간: perioperative (From the awakening period to immediately after tracheal extubation)
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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)
|
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Blood pressure
기간: From the induction period until 5 minutes after the completion of surgery
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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
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Sore throat score
기간: Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively
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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
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Hoarseness scores
기간: Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively
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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
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Surgical area pain scores
기간: Postoperative day 1 and day 2
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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
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Postoperative nausea and vomiting(PONV) score
기간: Within day 2 after surgery
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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
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Upper Aerodigestive Symptoms After Thyroidectomy (UADS) questionnaire score
기간: Three month after surgery
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Upper Aerodigestive Symptoms After Thyroidectomy Questionnaire; Instructions: 0=No problem, 1=Minor, 2=Moderate, 3=Major. Voice symptoms
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Three month after surgery
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Heart rate
기간: Time Frame: From the induction period until 5 minutes after the completion of surgery
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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
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Oxygen saturation
기간: Time Frame: From the induction period until 5 minutes after the completion of surgery
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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
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PACU RASS score
기간: perioperative (Record once every ten minutes from the time of entering the post-anesthesia care unit until leaving the recovery room.)
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perioperative (Record once every ten minutes from the time of entering the post-anesthesia care unit until leaving the recovery room.)
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Sleep scores
기간: Postoperative 24 hours and 48 hours
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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
|
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기타 연구 ID 번호
기타 연구 ID 번호
- YX2026-124
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