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

Harbin Medical University

Status: Enrolling

Conditions: Gastrointestinal Disease

Treatments: Combination Product: remimazolam-remifentanil; Combination Product: remimazolam-esketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT07002801

ChiCTR2500098650

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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280 participants in 2 patient groups

remimazolam plus esketamine group

Experimental group

Description:

Esketamine combined with remimazolamwas used for anesthesia.

Treatment:

Combination Product: remimazolam-esketamine

remimazolam plus remifentanil group

Active Comparator group

Description:

Remifentanil combined with remimazolam was used for anesthesia.

Treatment:

Combination Product: remimazolam-remifentanil