Application of Remimazolam Combined With Esketamine in Painless Gastroscopy and Colonoscopy in Elderly Patients
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: remimazolam-remifentanil, remimazolam-esketamine.
- Who it may be relevant to
- Registry conditions: Gastrointestinal Disease. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Combination product 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. - Combination product 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.
Primary outcome measures
- Sedation success rate [Time frame: From the start of anesthesia induction to the end of the surgery]
- Incidence of hypotension [Time frame: From the start of anesthesia induction to the end of the surgery]
Secondary outcome measures (12)
- degree of blood oxygen saturation [Time frame: From the start of anesthesia induction to the end of the surgery]
- respiratory rate [Time frame: From the start of anesthesia induction to the end of the surgery]
- bispectral index [Time frame: From the start of anesthesia induction to the end of the surgery]
- Heart rate [Time frame: From the start of anesthesia induction to the end of the surgery]
- Blood pressure [Time frame: From the start of anesthesia induction to the end of the surgery]
- Modified Observer's Assessment of Alertness/Sedation Scale [Time frame: From the start of anesthesia induction to the end of the surgery]
- Hiccup [Time frame: From the start of anesthesia induction to the end of the surgery]
- cough [Time frame: From the start of anesthesia induction to the end of the surgery]
- Physical movement [Time frame: From the start of anesthesia induction to the end of the surgery]
- Grade of abdominal wall muscle stiffness [Time frame: From the start of anesthesia induction to the end of the surgery]
- time index [Time frame: From the start of anesthesia induction to the end of the surgery]
- The usage of anesthetic drugs [Time frame: From the start of anesthesia induction to the end of the surgery]
Eligibility criteria
Inclusion criteria
- Patients undergoing painless gastroenteroscopy in outpatient clinics;
- aged 65 years and above;
- American Society of Anesthesiologists (ASA) grades I - III.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Harbin Medical University — Harbin
Identifiers
NCT: NCT07002801 · ChiCTR2500098650