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Gastrointestinal DiseaseNCT07002801

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

A study testing remimazolam-remifentanil and remimazolam-esketamine in people with Gastrointestinal Disease, run by Harbin Medical University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Gastrointestinal Disease
What is being tested?
remimazolam-remifentanil and remimazolam-esketamine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
1 siteChina
Study dates
14 May 2025to 10 Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

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

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

Other trials in China

About this study

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?
Read more

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.
Read the 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.

Being tested
remimazolam-remifentanil, remimazolam-esketamine
Keywords
remimazolam, esketamine, painless gastroscopy and colonoscopy, success rate of calming down
Medical subject headings
Gastrointestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • remimazolam-remifentanilCombination 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-esketamineCombination 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.

Study groups in NCT07002801
Study groupRoleWhat they receive
remimazolam plus esketamine groupExperimentalEsketamine combined with remimazolamwas used for anesthesia.
Receives: Combination Product: remimazolam-esketamine
remimazolam plus remifentanil groupActive comparatorRemifentanil combined with remimazolam was used for anesthesia.
Receives: Combination Product: remimazolam-remifentanil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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

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

Secondary outcomes (18)
  1. degree of blood oxygen saturation

    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.

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

  2. respiratory rate

    The respiratory rate was recorded every 2 minutes during the operation. The normal breathing rate is 12 to 20 breaths per minute.

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

  3. bispectral index

    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.

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

  4. Heart rate

    The heart rate was recorded every 2 minutes during the operation. The normal heart rate is 60 to 100 beats per minute.

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

  5. Blood pressure

    The blood pressure was recorded every 2 minutes during the operation.

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

  6. Modified Observer's Assessment of Alertness/Sedation Scale

    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.

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

  7. Hiccup

    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).

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

  8. cough

    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).

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

  9. Physical movement

    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.

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

  10. Grade of abdominal wall muscle stiffness

    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)

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

  11. time index

    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.

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

  12. The usage of anesthetic drugs

    Record the consumption amounts of lidocaine, esketamine, remifentanil and remimazolam during the operation

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

  13. Adverse event

    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.

    Measured: 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.

  14. The satisfaction of patients

    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.

    Measured: Ask the patient after they regain consciousness.

  15. The satisfaction of doctor

    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.

    Measured: At the end of the surgery

  16. Patient pain score

    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).

    Measured: After the patient regained consciousness

  17. Telephone Interview for Cognitive Status

    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.

    Measured: Before the start of the surgery, after the anesthesia wore off, and on the seventh day after the surgery

  18. The Confusion Assessment Method---CAM

    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.

    Measured: The seventh day after the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2025
  2. Study start14 May 2025
  3. Primary completion30 Jun 2026
  4. Study completion10 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07002801
Sponsor's protocol ID
ChiCTR2500098650
Status last verified
Oct 2026
First submitted
12 May 2025
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The original data sharing platform (IPD sharing platform) of ResMan, a clinical trial registration center of China, on June 30, 2028.

Questions about this trial

What is this clinical trial studying?

A study testing remimazolam-remifentanil and remimazolam-esketamine in people with Gastrointestinal Disease, run by Harbin Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sedation success rate (time frame: From the start of anesthesia induction to the end of the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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