Gastrointestinal DiseasesNCT07083440
Varied Remimazolam Dosages for Pediatric Endoscopy
A study testing Remimazolam, Propofol and Sufentanil in people with Gastrointestinal Diseases, run by Children's Hospital of Hebei Province at 1 site in China.
Trial summary
This prospective, randomized, comparative study aims to compare the efficacy and safety of three different doses of remimazolam (0.2 mg/kg, 0.3 mg/kg, and 0.4 mg/kg) combined with sufentanil and propofol for painless gastroscopy in pediatric patients. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Gastrointestinal Diseases
- What is being tested?
- Remimazolam, Propofol and Sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients scheduled for elective gastrointestinal endoscopy under anesthesia.
- Patients classified as American Society of Anesthesiologists (ASA) physical status I or II.
- Patients aged 3 to under 18 years of age.
- Written informed consent provided by parents or legal guardians.
Who cannot join
- Patients with known or suspected difficult airway, severe systemic disease (ASA ≥ III).
- Uncorrected significant abnormal liver or kidney function that could significantly alter drug metabolism (e.g., AST/ALT > 2x upper limit of normal, eGFR < 30 mL/min/1.73m²).
- Known allergy to study medications (remimazolam, propofol, sufentanil, or their components including egg or soy for propofol).
- Congenital illnesses such as severe congenital heart disease, or other conditions that may impact treatment observation or increase anesthetic risk.
- Patients who were obese (defined as BMI > 95th percentile for age and sex) or severely malnourished (BMI < 3rd percentile for age and sex).
- Patients who had taken sedatives, opioid analgesics (other than prescribed for chronic pain), or psychotropic medications (e.g., antidepressants, antipsychotics) within 24 hours prior to the procedure (unless part of their regular, stable medication regimen for a chronic condition, as assessed and deemed safe by the anesthesiologist).
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- Patients with pre-existing severe, uncontrolled mental illness or significant cognitive dysfunction that would preclude assessment of sedation or cooperation.
- Patients who had participated in other clinical trials within the past 4 weeks.
- Contraindications to the planned endoscopic procedure (e.g., recent gastrointestinal perforation, bowel obstruction).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Investigation of Varied Remimazolam Dosages With Sufentanil and Propofol for Painless Pediatric Gastrointestinal Endoscopy
This prospective, randomized, comparative study aims to compare the efficacy and safety of three different doses of remimazolam (0.2 mg/kg, 0.3 mg/kg, and 0.4 mg/kg) combined with sufentanil and propofol for painless gastroscopy in pediatric patients. The study will assess sedation quality, propofol consumption, hemodynamic stability, and adverse event profiles to identify an optimal remimazolam dosing regimen.
Read the detailed description
Pediatric patients undergoing gastrointestinal endoscopy often require deep sedation. Propofol is commonly used but can cause injection pain, respiratory depression, and hemodynamic instability. Remimazolam, a novel ultra-short-acting benzodiazepine, offers rapid onset, predictable recovery, and potentially better hemodynamic stability. This study investigates three doses of remimazolam (0.2 mg/kg, 0.3 mg/kg, and 0.4 mg/kg) co-administered with sufentanil (0.1 µg/kg) and titrated propofol to achieve a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤ 2 in 180 pediatric patients (ASA I-II, aged <18 years) undergoing gastroscopy. Patients are randomly assigned to one of three remimazolam dose groups. The study will evaluate total propofol dosage, hemodynamic changes (blood pressure, heart rate), time to sedation, awakening and recovery times, incidence of adverse events (e.g., hypotension, respiratory depression, injection pain), and satisfaction scores. The goal is to determine a remimazolam dose that provides effective sedation with reduced propofol requirements and an improved safety profile.
- Conditions
- Gastrointestinal Diseases
- Being tested
- Remimazolam, Propofol, Sufentanil
- Keywords
- Remimazolam, Painless gastrointestinal endoscopy, Sufentanil, Propofol, Pediatric
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Intravenous bolus administered over 1 minute (prepared as a 1 mg/mL solution). Doses: 0.2 mg/kg, 0.3 mg/kg, or 0.4 mg/kg according to group allocation.
PropofolDrug
Intravenous (10 mg/mL emulsion), initial titrated dose ranging from 0.5 to 2 mg/kg, administered slowly until MOAA/S ≤ 2. Supplemental 0.5 mg/kg boluses as needed.
SufentanilDrug
Intravenous dose of 0.1 µg/kg administered approximately 30 minutes before the start of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam 0.2 mg/kg Group (R2) | Experimental | Experimental. Patients receive remimazolam 0.2 mg/kg. Receives: Drug: Remimazolam; Drug: Propofol; Drug: Sufentanil |
| Remimazolam 0.3 mg/kg Group (R3) | Experimental | Experimental. Patients receive remimazolam 0.3 mg/kg. Receives: Drug: Remimazolam; Drug: Propofol; Drug: Sufentanil |
| Remimazolam 0.4 mg/kg Group (R4) | Experimental | Experimental. Patients receive remimazolam 0.4 mg/kg. Receives: Drug: Remimazolam; Drug: Propofol; Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Propofol Dosage
Total amount of propofol (mg) administered during the gastroscopy procedure to maintain MOAA/S score ≤ 2.
Measured: Periprocedural (during the gastroscopy procedure, lasting approximately 15-30 minutes)
Incidence of Hypotension
Percentage of patients experiencing hypotension, defined as a systolic blood pressure (SBP) decrease greater than 20% from baseline or below the 5th percentile for age, sustained for >2 minutes, or requiring intervention.
Measured: From induction of anesthesia through discharge from the Post-Anesthesia Care Unit (up to approximately 2 hours)
Secondary outcomes (13)
Hemodynamic Stability: Systolic Blood Pressure (SBP)
Systolic Blood Pressure (SBP) in mmHg. Assessed at 6 time points: Baseline (before anesthesia induction), immediately after induction, at gastroscope insertion, 5 minutes after gastroscope insertion, upon patient awakening, and at discharge from the Post-Anesthesia Care Unit (PACU).
Measured: From Baseline through discharge from the Post-Anesthesia Care Unit (up to approximately 2 hours post-procedure).
Hemodynamic Stability: Diastolic Blood Pressure (DBP)
Diastolic Blood Pressure (DBP) in mmHg. Assessed at 6 time points: Baseline (before anesthesia induction), immediately after induction, at gastroscope insertion, 5 minutes after gastroscope insertion, upon patient awakening, and at discharge from the Post-Anesthesia Care Unit (PACU).
Measured: From Baseline through discharge from the Post-Anesthesia Care Unit (up to approximately 2 hours post-procedure).
Hemodynamic Stability: Heart Rate (HR)
Heart Rate (HR) in beats/minute. Assessed at 6 time points: Baseline (before anesthesia induction), immediately after induction, at gastroscope insertion, 5 minutes after gastroscope insertion, upon patient awakening, and at discharge from the Post-Anesthesia Care Unit (PACU).
Measured: From Baseline through discharge from the Post-Anesthesia Care Unit (up to approximately 2 hours post-procedure).
Success Rate of Sedation
Percentage of patients successfully completing gastroscopy with MOAA/S ≤ 2 without requiring alternative sedative agents or premature termination.
Measured: At the conclusion of the gastroscopy procedure
Time to Induce Sedation
Time (minutes) from start of remimazolam injection to MOAA/S ≤ 2.
Measured: During the induction of anesthesia (within the first 5 minutes)
Awakening Time
Time (minutes) from the last dose of sedative/end of procedure to the patient opening their eyes spontaneously or on command.
Measured: Immediately following the end of the procedure
Recovery Time in PACU
Time (minutes) spent in the PACU until Aldrete score ≥ 9.
Measured: Throughout the Post-Anesthesia Care Unit stay (up to 90 minutes)
Number of Patients Requiring Supplemental Propofol Boluses
Count and percentage of patients requiring additional boluses of propofol after the initial induction dose.
Measured: During the gastroscopy procedure
Incidence of Respiratory Depression
Percentage of patients experiencing respiratory depression (SpO2 < 90% for >30 seconds despite increased FiO2, apnea > 20 seconds, or signs of airway obstruction requiring intervention).
Measured: From induction of anesthesia until emergence
Incidence of Injection Pain
Percentage of patients experiencing bradycardia (heart rate decrease > 20% from baseline or below 5th percentile for age, especially if accompanied by hypotension or poor perfusion, requiring intervention).
Measured: During intravenous drug administration at induction
Incidence of Postoperative Nausea and Vomiting (PONV)
Percentage of patients experiencing nausea or vomiting.
Measured: Assessed in the Post-Anesthesia Care Unit and at 24 hours post-procedure
Incidence of Dizziness/Vertigo
Percentage of patients reporting dizziness or vertigo.
Measured: Assessed in the Post-Anesthesia Care Unit and at 24 hours post-procedure
Satisfaction Scores
Satisfaction levels of endoscopists, patients (if age ≥ 7 years and able to respond), and guardians, evaluated using a seven-point Likert scale (1 = very dissatisfied to 7 = very satisfied).
Measured: Assessed once at the time of discharge from the Post-Anesthesia Care Unit (PACU), which occurs approximately 30 to 90 minutes after the end of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Jun 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal DiseasesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Hebei Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenjing Chen, Children's Hospital of Hebei Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083440
- Sponsor's protocol ID
- ECH-2023-010
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen W, Shi L, Bao W, Liu Y, Shi J. Optimal remimazolam dosage for pediatric painless gastrointestinal endoscopy: a randomized controlled trial comparing efficacy and safety of three doses combined with sufentanil and propofol. BMC Anesthesiol. 2026 Jan 2;26(1):80. doi: 10.1186/s12871-025-03511-2.
PubMed 41484821
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation of Varied Remimazolam Dosages With Sufentanil and Propofol for Painless Pediatric Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT07083440
- Acronym / sponsor ID
- ECH-2023-010
- Conditions
- Gastrointestinal Diseases
- Keywords
- Remimazolam, Painless gastrointestinal endoscopy, Sufentanil, Propofol, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Children's Hospital of Hebei ProvinceUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 24 Jul 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.
This prospective, randomized, comparative study aims to compare the efficacy and safety of three different doses of remimazolam (0.2 mg/kg, 0.3 mg/kg, and 0.4 mg/kg) combined with sufentanil and propofol for painless gastroscopy in pediatric patients. The study will assess sedation quality, propofol consumption, hemodynamic stability, and adverse event profiles to identify an optimal remimazolam dosing regimen.
Detailed description
Pediatric patients undergoing gastrointestinal endoscopy often require deep sedation. Propofol is commonly used but can cause injection pain, respiratory depression, and hemodynamic instability. Remimazolam, a novel ultra-short-acting benzodiazepine, offers rapid onset, predictable recovery, and potentially better hemodynamic stability. This study investigates three doses of remimazolam (0.2 mg/kg, 0.3 mg/kg, and 0.4 mg/kg) co-administered with sufentanil (0.1 µg/kg) and titrated propofol to achieve a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤ 2 in 180 pediatric patients (ASA I-II, aged <18 years) undergoing gastroscopy. Patients are randomly assigned to one of three remimazolam dose groups. The study will evaluate total propofol dosage, hemodynamic changes (blood pressure, heart rate), time to sedation, awakening and recovery times, incidence of adverse events (e.g., hypotension, respiratory depression, injection pain), and satisfaction scores. The goal is to determine a remimazolam dose that provides effective sedation with reduced propofol requirements and an improved safety profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remimazolam 0.2 mg/kg Group (R2) | Experimental | Drug: Remimazolam, Drug: Propofol, Drug: SufentanilExperimental. Patients receive remimazolam 0.2 mg/kg. |
| Remimazolam 0.3 mg/kg Group (R3) | Experimental | Drug: Remimazolam, Drug: Propofol, Drug: SufentanilExperimental. Patients receive remimazolam 0.3 mg/kg. |
| Remimazolam 0.4 mg/kg Group (R4) | Experimental | Drug: Remimazolam, Drug: Propofol, Drug: SufentanilExperimental. Patients receive remimazolam 0.4 mg/kg. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients scheduled for elective gastrointestinal endoscopy under anesthesia.
- Patients classified as American Society of Anesthesiologists (ASA) physical status I or II.
- Patients aged 3 to under 18 years of age.
- Written informed consent provided by parents or legal guardians.
Key exclusion criteria (9 listed)
- Patients with known or suspected difficult airway, severe systemic disease (ASA ≥ III).
- Uncorrected significant abnormal liver or kidney function that could significantly alter drug metabolism (e.g., AST/ALT > 2x upper limit of normal, eGFR < 30 mL/min/1.73m²).
- Known allergy to study medications (remimazolam, propofol, sufentanil, or their components including egg or soy for propofol).
- Congenital illnesses such as severe congenital heart disease, or other conditions that may impact treatment observation or increase anesthetic risk.
- Patients who were obese (defined as BMI > 95th percentile for age and sex) or severely malnourished (BMI < 3rd percentile for age and sex).
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 |
|---|---|---|
| RemimazolamIntravenous bolus administered over 1 minute (prepared as a 1 mg/mL solution). Doses: 0.2 mg/kg, 0.3 mg/kg, or 0.4 mg/kg according to group allocation. | Drug | Remimazolam 0.2 mg/kg Group (R2), Remimazolam 0.3 mg/kg Group (R3), Remimazolam 0.4 mg/kg Group (R4) |
| PropofolIntravenous (10 mg/mL emulsion), initial titrated dose ranging from 0.5 to 2 mg/kg, administered slowly until MOAA/S ≤ 2. Supplemental 0.5 mg/kg boluses as needed. | Drug | Remimazolam 0.2 mg/kg Group (R2), Remimazolam 0.3 mg/kg Group (R3), Remimazolam 0.4 mg/kg Group (R4) |
| SufentanilIntravenous dose of 0.1 µg/kg administered approximately 30 minutes before the start of the procedure. | Drug | Remimazolam 0.2 mg/kg Group (R2), Remimazolam 0.3 mg/kg Group (R3), Remimazolam 0.4 mg/kg Group (R4) |
Primary outcome
Total Propofol Dosage
Time frame: Periprocedural (during the gastroscopy procedure, lasting approximately 15-30 minutes)
Total amount of propofol (mg) administered during the gastroscopy procedure to maintain MOAA/S score ≤ 2.
Incidence of Hypotension
Time frame: From induction of anesthesia through discharge from the Post-Anesthesia Care Unit (up to approximately 2 hours)
Percentage of patients experiencing hypotension, defined as a systolic blood pressure (SBP) decrease greater than 20% from baseline or below the 5th percentile for age, sustained for >2 minutes, or requiring intervention.
13 secondary outcomes
Hemodynamic Stability: Systolic Blood Pressure (SBP)
Time frame: From Baseline through discharge from the Post-Anesthesia Care Unit (up to approximately 2 hours post-procedure).
Hemodynamic Stability: Diastolic Blood Pressure (DBP)
Time frame: From Baseline through discharge from the Post-Anesthesia Care Unit (up to approximately 2 hours post-procedure).
Hemodynamic Stability: Heart Rate (HR)
Time frame: From Baseline through discharge from the Post-Anesthesia Care Unit (up to approximately 2 hours post-procedure).
Success Rate of Sedation
Time frame: At the conclusion of the gastroscopy procedure
Time to Induce Sedation
Time frame: During the induction of anesthesia (within the first 5 minutes)
Awakening Time
Time frame: Immediately following the end of the procedure
Recovery Time in PACU
Time frame: Throughout the Post-Anesthesia Care Unit stay (up to 90 minutes)
Number of Patients Requiring Supplemental Propofol Boluses
Time frame: During the gastroscopy procedure
Incidence of Respiratory Depression
Time frame: From induction of anesthesia until emergence
Incidence of Injection Pain
Time frame: During intravenous drug administration at induction
Incidence of Postoperative Nausea and Vomiting (PONV)
Time frame: Assessed in the Post-Anesthesia Care Unit and at 24 hours post-procedure
Incidence of Dizziness/Vertigo
Time frame: Assessed in the Post-Anesthesia Care Unit and at 24 hours post-procedure
Satisfaction Scores
Time frame: Assessed once at the time of discharge from the Post-Anesthesia Care Unit (PACU), which occurs approximately 30 to 90 minutes after the end of the procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Derived from this study: PubMed 41484821Chen W, Shi L, Bao W, Liu Y, Shi J. Optimal remimazolam dosage for pediatric painless gastrointestinal endoscopy: a randomized controlled trial comparing efficacy and safety of three doses combined with sufentanil and propofol. BMC Anesthesiol. 2026 Jan 2;26(1):80. doi: 10.1186/s12871-025-03511-2.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, Propofol and Sufentanil in people with Gastrointestinal Diseases, run by Children's Hospital of Hebei Province 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 24 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total Propofol Dosage (time frame: Periprocedural (during the gastroscopy procedure, lasting approximately 15-30 minutes)). 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?
On the ClinicalTrials.gov record for NCT07083440, which also lists 1 linked publication.
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 24 Jul 2025.