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.
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;
Show all 10Show fewer
- 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
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.
- Conditions
- Gastrointestinal Disease
- 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 group | Role | What they receive |
|---|---|---|
| remimazolam plus esketamine group | Experimental | Esketamine combined with remimazolamwas used for anesthesia. Receives: Combination Product: remimazolam-esketamine |
| remimazolam plus remifentanil group | Active comparator | Remifentanil 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.
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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.
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.
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
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
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
The Confusion Assessment Method---CAM
- Applicable population: Elderly patients, especially those who have undergone surgery or have cognitive impairments.
- 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.
- 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.
- First posted4 Jun 2025
- Study start14 May 2025
- Primary completion30 Jun 2026
- Study completion10 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Harbin Medical University
- Responsible party
- Principal investigator, Shi xiaoqian, Harbin Medical University
- Investigators
- SHI Jinghui SHI, Study director
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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Remimazolam Combined With Esketamine in Painless Gastroscopy and Colonoscopy in Elderly Patients
- ClinicalTrials.gov ID
- NCT07002801
- Acronym / sponsor ID
- ChiCTR2500098650
- Conditions
- Gastrointestinal Disease
- Keywords
- remimazolam, esketamine, painless gastroscopy and colonoscopy, success rate of calming down
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Harbin Medical University
- Study start
- 14 May 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 10 Oct 2028 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remimazolam plus esketamine group | Experimental | Combination Product: remimazolam-esketamineEsketamine combined with remimazolamwas used for anesthesia. |
| remimazolam plus remifentanil group | Active comparator | Combination Product: remimazolam-remifentanilRemifentanil combined with remimazolam was used for anesthesia. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients undergoing painless gastroenteroscopy in outpatient clinics;
- aged 65 years and above;
- American Society of Anesthesiologists (ASA) grades I - III.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remimazolam-remifentanilFor 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. | Combination product | remimazolam plus remifentanil group |
| remimazolam-esketamineFor 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. | Combination product | remimazolam plus esketamine group |
Primary outcome
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
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
18 secondary outcomes
degree of blood oxygen saturation
Time frame: 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
bispectral index
Time frame: 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
Blood pressure
Time frame: 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
Hiccup
Time frame: 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
Physical movement
Time frame: 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
time index
Time frame: 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
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.
The satisfaction of patients
Time frame: Ask the patient after they regain consciousness.
The satisfaction of doctor
Time frame: At the end of the surgery
Patient pain score
Time frame: 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 Confusion Assessment Method---CAM
Time frame: The seventh day after the operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Yes. The original data sharing platform (IPD sharing platform) of ResMan, a clinical trial registration center of China, on June 30, 2028.
Related trials for Gastrointestinal Disease
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SHI Jinghui SHI study director
1 site in 1 country: see every site and its status.
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.