Application of Remimazolam Combined With Esketamine in Painless Gastroscopy and Colonoscopy in Elderly Patients

Обзор

The objective of this clinical trial is to assess the feasibility of the remimazolam combined with esketamine OFA (opioid-free anesthesia) protocol for painless gastroscopy and colonoscopy in elderly patients and to determine if it is non-inferior to the traditional OA (opioid-containing anesthesia) protocol. The main questions it aims to answer are: * Is the remimazolam combined with esketamine protocol feasible for painless gastroscopy and colonoscopy in elderly patients? * Is the OFA protocol superior to the OA protocol? Participants will: * During anesthesia induction, the experimental group will receive remimazolam combined with esketamine for anesthesia, while the control group will receive remimazolam combined with remifentanil. * Record respiratory and circulatory indicators and adverse reaction times.

Подробное описание

Elderly patients undergoing painless gastroenteroscopy were randomly divided into remazolam + esketamine group (RE group) and remazolam + remifentanil group (RR group). In RE group, anesthesia induction was as follows: Remazolam 0.2mg/kg, esketamine 0.15mg/kg, lidocaine 0.5mg/kg, changtonine 0.2mg. RR group: Anesthesia induction: remazolam 0.2mg/kg, remifentanil 0.2μg/kg, lidocaine 0.5mg/kg, Changtonine 0.2mg. Remazolam and esketamine/remifentanil were added during the operation according to the depth of sedation and movement of the patient. The outcome measures included success rate of sedation, incidence of respiratory depression, incidence of hypotension and bradycardia, postoperative recovery time, incidence of adverse reactions, postoperative satisfaction of patients and gastroenteroscopists.

Вмешательства

• Комбинированный продукт remimazolam-remifentanil
  For elderly patients scheduled for elective painless gastro-intestinal endoscopy, remimazolam 0.2mg/kg and remifentanil 0.2ug/kg are used for anesthesia induction. During the operation, the doses are adjusted according to the depth of sedation of the patients.
• Комбинированный продукт remimazolam-esketamine
  For elderly patients scheduled for painless gastroenterological endoscopy, remimazolam 0.2mg/kg and esketamine 0.15mg/kg are used for anesthesia induction. During the operation, the dosage is adjusted according to the patient's level of sedation.

Первичные конечные точки

• Sedation success rate [Срок оценки: From the start of anesthesia induction to the end of the surgery]
• Incidence of hypotension [Срок оценки: From the start of anesthesia induction to the end of the surgery]

Вторичные конечные точки (12)

• degree of blood oxygen saturation [Срок оценки: From the start of anesthesia induction to the end of the surgery]
• respiratory rate [Срок оценки: From the start of anesthesia induction to the end of the surgery]
• bispectral index [Срок оценки: From the start of anesthesia induction to the end of the surgery]
• Heart rate [Срок оценки: From the start of anesthesia induction to the end of the surgery]
• Blood pressure [Срок оценки: From the start of anesthesia induction to the end of the surgery]
• Modified Observer's Assessment of Alertness/Sedation Scale [Срок оценки: From the start of anesthesia induction to the end of the surgery]
• Hiccup [Срок оценки: From the start of anesthesia induction to the end of the surgery]
• cough [Срок оценки: From the start of anesthesia induction to the end of the surgery]
• Physical movement [Срок оценки: From the start of anesthesia induction to the end of the surgery]
• Grade of abdominal wall muscle stiffness [Срок оценки: From the start of anesthesia induction to the end of the surgery]
• time index [Срок оценки: From the start of anesthesia induction to the end of the surgery]
• The usage of anesthetic drugs [Срок оценки: From the start of anesthesia induction to the end of the surgery]

Критерии участия

Критерии включения

• Patients undergoing painless gastroenteroscopy in outpatient clinics;
• aged 65 years and above;
• American Society of Anesthesiologists (ASA) grades I - III.

Критерии исключения

• Patients with abnormal liver or kidney function;
• known respiratory or endocrine diseases;
• Patients with uncontrolled hypertension and NYHA classification Ⅲ-Ⅳ;
• Taking monoamine oxidase inhibitors, sedatives, analgesics, hypnotics, antipsychotics, antiemetics or antidepressants;
• Addiction to tobacco and alcohol;
• Patients allergic to the investigational drug;
• expected difficult airway;
• Body mass index (BMI) >35kg/m\^2;
• Have participated in other clinical trials within the past three months;
• Patients with psychosocial illness or cognitive dysfunction and inability to cooperate or communicate.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Harbin Medical University — Харбин

Идентификаторы

NCT: NCT07002801 · ChiCTR2500098650

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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