A Phase 4 interventional study of Fentanyl and Propofol and Esketamine and remimazolam in Adverse Respiratory Events, Hypoxemia and Children, sponsored by Second Affiliated Hospital of Wenzhou Medical University. Not yet recruiting at 1 site in China. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Second Affiliated Hospital of Wenzhou Medical University · Phase 4, Interventional, and Prevention
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.
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.
1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.
This study's planned enrollment of 120 is above the median of 45 across 769 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →Second Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 137 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Propofol 3 mg/kg + Fentanyl 2 μg/kg.
Drug: Fentanyl and Propofol
Remimazolam Besylate 0.65 mg/kg + Esketamine 0.5 mg/kg.
Drug: Esketamine and remimazolam
Drug pages: Fentanyl · Propofol
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.
Drug pages: Esketamine · Remimazolam
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.
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.
Time frame: From the start of anesthesia induction until the end of the procedure (gastroscopy withdrawal).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Start is estimated for Aug 2026; primary completion for Dec 2026, 4 months later.
Of 17 phase 4 interventional studies under Hypoxia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 47. This study's planned 4 months is below that.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Fentanyl · Propofol · Esketamine · Remimazolam
Second Affiliated Hospital of Wenzhou Medical University →