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

May 26, 2025 updated by: Shi xiaoqian, Harbin Medical University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Recruiting
        • The First Affiliated Hospital of Harbin Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • SHI Xiaoqian SHI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: remimazolam plus esketamine group
Esketamine combined with remimazolamwas used for anesthesia.
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.
Active Comparator: remimazolam plus remifentanil group
Remifentanil combined with remimazolam was used for anesthesia.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sedation success rate
Time Frame: From the start of anesthesia induction to the end of the surgery
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
Time Frame: From the start of anesthesia induction to the end of the surgery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
degree of blood oxygen saturation
Time Frame: From the start of anesthesia induction to the end of the surgery
The blood oxygen saturation was recorded every 2 minutes during the operation. The maximum value is 100. An event where blood oxygen saturation drops below 90 is described as respiratory depression.
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
The respiratory rate was recorded every 2 minutes during the operation. The normal breathing rate is 12 to 20 breaths per minute.
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
During the surgery, the bilateral frequency index of brain electricity was recorded every 2 minutes. The bispectral index of electroencephalogram is mainly used to assess the depth of sedation, the effect of anesthesia and the state of consciousness. Its value range is from 0 to 100. The higher the value, the higher the degree of consciousness; the lower the value, the deeper the degree of brain inhibition.
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
The heart rate was recorded every 2 minutes during the operation. The normal heart rate is 60 to 100 beats per minute.
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
The blood pressure was recorded every 2 minutes during the operation.
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

The MOAA/S, which stands for Modified Observer's Assessment of Alertness/Sedation Scale, assesses the patient's response to sounds or physical stimuli and is scored on a scale of 6 levels:

Level 5: Normal alertness, quick response to normal tone of voice; Level 4: Slow response to normal tone of voice; Level 3: Only responds to loud or repeated calls; Level 2: Only responds to slight shaking or tactile stimuli; Level 1: No response to slight shaking or tactile stimuli, but responds to pain stimuli (such as pinching the trapezius muscle); Level 0: No response to pain stimuli. During the surgery, the MOAA/S value was recorded every 2 minutes.
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
Level 0: No hiccups; Level 1: Single mild hiccup; Level 2: Multiple mild hiccups, not affecting the surgical operation (≤ 5 seconds); Level 3: Severe hiccups, affecting the surgical operation (> 5 seconds).
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
Level 0: No choking coughing action; Level 1: A single mild choking coughing action; Level 2: Multiple mild choking coughing actions, which do not affect the surgical operation (≤ 5 seconds); Level 3: Severe coughing (> 5 seconds).
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
Level 1: No activity: Level 2: Slight activity, does not affect operation: Level 3: Obvious activity, has some impact on surgical operation; Level 4: Limb twisting, significantly affects operation.
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
No; moderate (by pressing the abdomen, the abdominal wall muscles become stiff, which affects the colonoscopy examination); Severe (by pressing the abdomen, the abdominal wall muscles become stiff, severely affecting the colonoscopy examination)
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 induction time of anesthesia is the period from the start of administering remimazolam and remifentanil (esketamine) until the patient loses consciousness and is ready for surgery. The operation time is the duration from the beginning of the gastroscopy procedure to the end of the colonoscopy. The period of full consciousness is from the last administration of anesthetic drugs until the patient regains consciousness. The anesthesia recovery time is the duration from the time the patient regains consciousness to the time when the Aldrete score reaches 9 points.
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
Record the consumption amounts of lidocaine, esketamine, remifentanil and remimazolam during the operation
From the start of anesthesia induction to the end of the surgery
Adverse event
Time Frame: 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.
Adverse events include intraoperative respiratory depression, hypotension, hypertension, bradycardia, tachycardia, arrhythmia, hiccups, choking cough, body movement, abdominal wall rigidity; postoperative nausea, vomiting, headache, dizziness, visual impairment, hallucination, intraoperative awareness, etc.
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.
The satisfaction of patients
Time Frame: Ask the patient after they regain consciousness.
The patient's satisfaction was measured using the visual analogue scale method. A 10-cm movable ruler with 10 marks was used, with the two ends marked as 0 and 10 respectively. The patient was asked to mark the corresponding position on the ruler that represented their satisfaction level. 0 represented extreme dissatisfaction and 10 represented very satisfaction.
Ask the patient after they regain consciousness.
The satisfaction of doctor
Time Frame: At the end of the surgery
The satisfaction of the doctors was measured using the visual analogue scale method. A 10-cm movable ruler was used, marked with 10 graduations, with the two ends representing 0 points and 10 points respectively. The doctors were asked to mark the corresponding position on the ruler that best represented their satisfaction level. 0 points indicated extreme dissatisfaction, while 10 points indicated very high satisfaction.
At the end of the surgery
Patient pain score
Time Frame: After the patient regained consciousness
The patient's pain score is classified into four levels: no pain, mild abdominal distension pain (pain is present only when pressed; no pain when not pressed), moderate abdominal pain (pain persists even when not pressed, but is tolerable), and severe abdominal pain (pain is unbearable).
After the patient regained consciousness
Telephone Interview for Cognitive Status
Time Frame: Before the start of the surgery, after the anesthesia wore off, and on the seventh day after the surgery
The Telephone Interview for Cognitive Status is a tool used to assess cognitive functions, especially suitable for remote screening of cognitive impairments. TICS is a standardized telephone interview scale that evaluates the cognitive functions of the subjects through questions, including orientation, memory, language ability, calculation ability, etc. It consists of 13 items, with a total score ranging from 0 to 50, and a lower score indicates more severe cognitive impairment.
Before the start of the surgery, after the anesthesia wore off, and on the seventh day after the surgery
The Confusion Assessment Method---CAM
Time Frame: The seventh day after the operation
  1. Applicable population: Elderly patients, especially those who have undergone surgery or have cognitive impairments.
  2. Assessment items: It includes 11 indicators, such as acute onset, attention disorder, disordered thinking, disorientation, etc. Each item is scored from 0 to 3 or 0 to 4 points.
  3. Diagnostic criteria: Total score: Below 19 points indicates no delirium, 20 to 22 points indicates suspicion, and above 22 points confirms the diagnosis.
The seventh day after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Harbin Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
First Affiliated Hospital of Harbin Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: SHI Jinghui SHI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 14, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ChiCTR2500098650

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The original data sharing platform (IPD sharing platform) of ResMan, a clinical trial registration center of China, on June 30, 2028.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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