Adverse Respiratory EventsPhase 4NCT07748884
Comparing Esketamine and Remazolam With Propofol for Breathing Safety in Pediatric Gastroscopy
A Phase 4 study testing Fentanyl and Propofol and Esketamine and remimazolam in people with Adverse Respiratory Events and Hypoxemia, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
Gastroscopy is important for diagnosing and treating upper gastrointestinal diseases in children. To ensure the procedure is safe and smooth, most children require sedation. Compared to adults, children have more fragile airways, lower lung capacity, and poorer oxygen reserves, making them more prone to breathing… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Adverse Respiratory Events, Hypoxemia, Children
- What is being tested?
- Fentanyl and Propofol and Esketamine and remimazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Aug 2026to Dec 2026
- Phase
- Phase 4
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6 to 12 years, both sexes;
- American Society of Anesthesiologists (ASA) physical status I or II;
- Scheduled for elective gastroscopy or esophagogastroduodenoscopy (EGD) under anesthesia;
- Preoperative oxygen saturation of 100% while breathing room air;
- Weight within the normal range for age and gender according to the following reference values (inclusive of endpoints)
Who cannot join
- Contraindications to sedation or anesthesia, or a history of adverse events related to sedation/anesthesia；
- Known or suspected allergy to the study drug, benzodiazepines, or their reversal agents；
- History of respiratory disease within the past 2 weeks, or known difficult airway (modified Mallampati score III or IV)；
- History of cardiac, hepatic, renal dysfunction, or metabolic diseases；
- Patients with congenital diseases or other conditions that may interfere with the evaluation of efficacy outcomes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University Wenzhou, Wenzhou, Zhejiang
Zhejiang
Huacheng Liu, 13957770577, huachengliu@163.com
About this study
Official title: A Comparative Study on the Incidence of Respiratory Adverse Events Between Esketamine Combined With Remazolam and Traditional Propofol in Pediatric Gastroscopy
Gastroscopy is important for diagnosing and treating upper gastrointestinal diseases in children. To ensure the procedure is safe and smooth, most children require sedation. Compared to adults, children have more fragile airways, lower lung capacity, and poorer oxygen reserves, making them more prone to breathing difficulties and low oxygen levels during sedation.
Esketamine, a stronger form of ketamine, helps maintain heart rate and blood pressure and may reduce breathing-related risks. Remimazolam, a new short-acting sedative, acts quickly, allows faster recovery, and has a better safety profile than propofol-it doesn't cause breathing problems or injection pain.
The safety and effectiveness of combining remimazolam with esketamine for pediatric gastroscopy have not been well studied. This research will compare this new combination with the traditional propofol-based approach to evaluate its potential benefits and safety in children.
Read the detailed description
Children scheduled for elective gastroscopy under general anesthesia were randomly allocated into two groups: the RA group (Remimazolam Besylate + Esketamine), consisting of 60 cases, and the PF group (Propofol + Fentanyl), also consisting of 60 cases. The induction doses for the RA group were: Remimazolam Besylate 0.65 mg/kg + Esketamine 0.5 mg/kg. The induction doses for the PF group were: Propofol 3 mg/kg + Fentanyl 2 μg/kg.
In the RA group, Esketamine 0.5 mg/kg was administered as a single intravenous bolus over 10 seconds. In the PF group, Fentanyl 2 μg/kg was administered as a single intravenous bolus over 10 seconds. After a 1-minute waiting period for both groups, Remimazolam Besylate 0.65 mg/kg was administered intravenously over 15 seconds in the RA group, while Propofol 3 mg/kg was administered intravenously over 15 seconds in the PF group. Gastroscopy commenced once the child's eyelash reflex disappeared and the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score was ≤1.
The following parameters were recorded: the time from intravenous induction drug administration to loss of consciousness; the incidence of respiratory adverse events during anesthesia (defined as SpO₂ <92% lasting ≥30 seconds, apnea, laryngospasm, or severe/persistent coughing); the success rate of intravenous anesthetic sedation; total gastroscopy procedure time; time to emergence from anesthesia; the incidence of postoperative agitation; MOAA/S scores; and vital signs including heart rate, blood pressure, and pulse oxygen saturation.
- Conditions
- Adverse Respiratory Events, Hypoxemia, Children, Gastroscopy, Esketamine, Remimazolam
- Being tested
- Fentanyl and Propofol, Esketamine and remimazolam
- Keywords
- Adverse respiratory events, Hypoxemia, Children, gastroscopy, Esketamine, Remimazolam
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl and PropofolDrug
In the PF group, Fentanyl 2 μg/kg was administered as a single intravenous bolus over 10 seconds. After a 1-minute waiting period for both groups, Propofol 3 mg/kg was administered intravenously over 15 seconds in the PF group.
Esketamine and remimazolamDrug
In the RA group, Esketamine 0.5 mg/kg was administered as a single intravenous bolus over 10 seconds.After a 1-minute waiting period for both groups, Remimazolam Besylate 0.65 mg/kg was administered intravenously over 15 seconds in the RA group.
| Study group | Role | What they receive |
|---|---|---|
| Group PF | Experimental | Propofol 3 mg/kg + Fentanyl 2 μg/kg. Receives: Drug: Fentanyl and Propofol |
| Group RA | Experimental | Remimazolam Besylate 0.65 mg/kg + Esketamine 0.5 mg/kg. Receives: Drug: Esketamine and remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Adverse Events During Anesthesia
Respiratory adverse events are defined as the occurrence of any of the following during the anesthesia period: hypoxemia (SpO₂ < 92% lasting ≥30 seconds), apnea, laryngospasm, and severe or persistent coughing.
Measured: From the start of anesthesia induction until the end of the procedure (gastroscopy withdrawal).
Secondary outcomes (4)
Success Rate of Intravenous Sedation
Success is defined as achieving a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤ 1 with the initial dose of the study anesthetic agent.
Measured: Assessed at the time of anesthesia induction (immediately after initial dose administration).
Success Rate of Gastroscopy Completion
Successful gastroscopy must meet all three requirements: (1) procedure completed without need for alternative sedation; (2) no more than 3 rescue sedation boluses within 5 minutes; and (3) meeting the predefined limits for number and dose of rescue boluses.
Measured: From gastroscope insertion until its withdrawal (entire procedure duration).
Emergence delirium
The pediatric anesthesia emergence delirium scale consists of five items. Each item is scored 0-4 yielding a total between 0 and 20. The degree of emergence delirium increased directly with the total score. pediatric anesthesia emergence delirium scale ≥12 at any time indicates presence of emergence delirium.
Measured: Within up to 15-30 minutes after child's first eye opening in the postoperative period
Awakening time
from the end of gastroscopy to first spontaneous eye-opening
Measured: From the withdrawal of the gastroscope (end of procedure) until the patient's first spontaneous eye-opening, assessed immediately during the post-anesthesia recovery period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Respiratory EventsStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huacheng Liu, Ph.D., Principal investigator, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748884
- Sponsor's protocol ID
- SAHoWMU-CR2026-03-116
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No