A Comparative Study of Rimazolam and Propofol Combined With Etomidate in Gastroenteroscopy in Elderly Patients

Peking University

Status: Completed

Conditions: Remimazolam Besylate; Gastrointestinal Endoscopy; Etomidate Combined With Propofol; Elderly Patients

Treatments: Drug: etomidate combined with propofol; Drug: Remimazolam Besylate

Study type: Interventional

Funder types: Other

Identifiers

NCT05103696

2021PHB002-001

Details and patient eligibility

About

Studies have shown that etomidate combined with propofol in gastroscopy has high safety and lower incidence of hypoxia and hypotension, suggesting the advantages of etomidate combined with propofol in elderly patients.

Remimazolam Besylate is a 1.1 class new drug that acts on GABA receptors and is metabolized by plasma esterase with fast metabolism time, only 1/7 of midazolam, which may be more suitable for elderly patients. Therefore, this study intends to explore the safety and effectiveness of two sedation schemes in gastroenteroscopy for elderly patients.

Full description

Before starting the endoscopy procedures, patients were randomly assigned to either Remimazolam Besylate group or propofol combined with etomidate group. The onset time, recovery time, vital signs, postoperative recovery, cognitive function and adverse events were compared.

Enrollment: 120 patients

Sex: All

Ages: 60 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with asAI-II indications for painless gastroenteroscopy and receiving diagnostic or therapeutic gastroenteroscopy;
2. Aged 60-75, body mass index (BMI) 19-28 kg/m2, Systolic blood pressure of 90-140mmHg, diastolic blood pressure of 50-90mmHg, resting heart rate of 50-100bpm and blood pulse oxygen saturation ≥95%

Exclusion criteria

1. Those who are refused to be included;

2. Those who are allergic to the drugs used in this study;

3. Epilepsy and other mental illnesses, a history of addiction such as opiates and other analgesics and/or tranquilizers (hypnotics);

4. Severe lung infection or upper respiratory tract infection;

5. Sleep apnea syndrome, difficult airway (Mallampati score of 3 or 4) or asthma status; 8. Advanced cancer accompanied by extensive intra-abdominal metastasis;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Remimazolam group

Experimental group

Description:

Patients received remimazolam to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. And patients were injected remifentanil 0.3μg/kg (infusion time \> 1min) at the first time，When the analgesia was insufficient, Remifentanil can be added according to the situation.

Treatment:

Drug: Remimazolam Besylate

EP group

Active Comparator group

Description:

Patients received Etomidate combined with propofol to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. And patients were injected remifentanil 0.3μg/kg (infusion time \> 1min) at the first time.When the analgesia was insufficient,Remifentanil can be added according to the situation

Treatment:

Drug: etomidate combined with propofol