Clinical trial NCT07002801: Application of Remimazolam Combined With Esketamine in Painless Gastroscopy and Colonoscopy in Elderly Patients
Official title: Application of Remimazolam Combined With Esketamine in Painless Gastroscopy and Colonoscopy in Elderly Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Disease
Keywords: remimazolam
esketamine
painless gastroscopy and colonoscopy
success rate of calming down
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Harbin Medical University
First posted: 2025-06-04
Enrollment: 280
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sedation success rate
timeFrame: From the start of anesthesia induction to the end of the surgery
measure: Incidence of hypotension
timeFrame: From the start of anesthesia induction to the end of the surgery
Secondary outcomes:
measure: degree of blood oxygen saturation
timeFrame: From the start of anesthesia induction to the end of the surgery
measure: respiratory rate
timeFrame: From the start of anesthesia induction to the end of the surgery
measure: bispectral index
timeFrame: From the start of anesthesia induction to the end of the surgery
measure: Heart rate
timeFrame: From the start of anesthesia induction to the end of the surgery
measure: Blood pressure
timeFrame: From the start of anesthesia induction to the end of the surgery
measure: Modified Observer's Assessment of Alertness/Sedation Scale
timeFrame: From the start of anesthesia induction to the end of the surgery
measure: Hiccup
timeFrame: From the start of anesthesia induction to the end of the surgery
measure: cough
timeFrame: From the start of anesthesia induction to the end of the surgery
measure: Physical movement
timeFrame: From the start of anesthesia induction to the end of the surgery
measure: Grade of abdominal wall muscle stiffness
timeFrame: From the start of anesthesia induction to the end of the surgery
measure: time index
timeFrame: From the start of anesthesia induction to the end of the surgery
measure: The usage of anesthetic drugs
timeFrame: From the start of anesthesia induction to the end of the surgery
measure: Adverse event
timeFrame: From the induction of anesthesia to the end of the surgery, and from the end of the surgery to the time when the patient leaves the anesthesia recovery room.
measure: The satisfaction of patients
timeFrame: Ask the patient after they regain consciousness.
measure: The satisfaction of doctor
timeFrame: At the end of the surgery
measure: Patient pain score
timeFrame: After the patient regained consciousness
measure: Telephone Interview for Cognitive Status
timeFrame: Before the start of the surgery, after the anesthesia wore off, and on the seventh day after the surgery
measure: The Confusion Assessment Method---CAM
timeFrame: The seventh day after the operation
Other outcomes:
Locations:
city: Harbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
Study officials:
name: SHI Jinghui SHI
role: STUDY_DIRECTOR
References: