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

NCT07002801 | Recruiting

• 1 other identifier: ChiCTR2500098650
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Disease

Keywords

remimazolam; esketamine; painless gastroscopy and colonoscopy; success rate of calming down

Outcome Measures

Primary Outcomes (2)

• Sedation success rate

  Successful sedation：① The patient underwent painless gastroenteroscopy;②During anesthesia induction, a single remazolam is not enough to achieve sufficient sedation depth, and it needs to be remedied, and the number of remediations within 15min is less than 5 times; Intraoperative supplementary times ≤5 times within any 15min.③ The patient did not use rescue drugs;Sedation success rate: Number of patients successfully sedated/total number of patients included in the data analysis for this group

  From the start of anesthesia induction to the end of the surgery

• Incidence of hypotension

  Hypotension: systolic blood pressure below 80% of baseline systolic blood pressure or MAP below 80% of baseline MAP; Incidence of hypotension: Number of patients with intraoperative hypotension/total number of patients included in the data analysis for this group

  From the start of anesthesia induction to the end of the surgery

Secondary Outcomes (18)

• degree of blood oxygen saturation

  From the start of anesthesia induction to the end of the surgery

• respiratory rate

  From the start of anesthesia induction to the end of the surgery

• bispectral index

  From the start of anesthesia induction to the end of the surgery

• Heart rate

  From the start of anesthesia induction to the end of the surgery

• Blood pressure

  From the start of anesthesia induction to the end of the surgery

Study Arms (2)

remimazolam plus esketamine group

EXPERIMENTAL

Esketamine combined with remimazolamwas used for anesthesia.

Combination Product: remimazolam-esketamine

remimazolam plus remifentanil group

ACTIVE COMPARATOR

Remifentanil combined with remimazolam was used for anesthesia.

Combination Product: remimazolam-remifentanil

Interventions

remimazolam-remifentanil COMBINATION_PRODUCT

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.

remimazolam plus remifentanil group

remimazolam-esketamine COMBINATION_PRODUCT

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.

remimazolam plus esketamine group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harbin Medical University: lead
• First Affiliated Hospital of Harbin Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• SHI Jinghui SHI

  STUDY DIRECTOR

Central Study Contacts

LIU Shujie LIU

CONTACT

+86 138 4508 0390; shujieliu312@163.com

SHI Xiaoqian SHI

CONTACT

+86 188 3424 7923; shixiaoqian005@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither the anesthesiologist nor the operator of the gastroscopy was aware of it.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate student

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: June 4, 2025
• Study Start: March 14, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)