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NCT04720963
Intranasal Remimazolam for Premedication in Pediatric Patient
Phase 4 trial testing Remimazolam in Sedative; Anxiety Disorder in 90 participants. Completed in 28 February 2022.
28 February 2022
Quick facts
| Lead sponsor | Second Affiliated Hospital of Wenzhou Medical University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 7 February 2021 |
| Primary completion | 28 February 2022 |
| Estimated completion | 28 February 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- Remimazolam — full drug profile →
- Distilled water for injection
- Dexmedetomidine (dexmedetomidine) — full drug profile →
Conditions studied
- Sedative; Anxiety Disorder — all drugs for Sedative; Anxiety Disorder →
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Who can join
Adults 2 to 5, any sex, with Sedative; Anxiety Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Anesthetic inhalation induction could be one of the most stressful experiences for children during the perioperative period, with almost 50% of them showing anxiety. It is an essential challenge for pediatric anesthesiologists on how to decrease anxiety for children in the operating room (OR) environment and to facilitate a smooth induction of anesthesia. Various factors like parental separation, unfamiliar surroundings, fear of physicians and needle injections can increase their preoperative anxiety. The researchers conducted the current study to investigate whether intranasal remimazolam can reduce anxiety in children before surgery.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Remimazolam: pharmacological characteristics and clinical applications in anesthesiology.
Kim KM. · · 2022 · cited 161× · PMID 35139608 · DOI 10.17085/apm.21115 -
Remimazolam: An Updated Review of a New Sedative and Anaesthetic.
Hu Q, Liu X, Wen C, Li D, et al · · 2022 · cited 120× · PMID 36411859 · DOI 10.2147/dddt.s384155 -
Preoperative Anxiolytic and Sedative Effects of Intranasal Remimazolam and Dexmedetomidine: A Randomized Controlled Clinical Study in Children Undergoing General Surgeries.
Cai YH, Wang CY, Fang YB, Ma HY, et al · · 2024 · cited 14× · PMID 38774484 · DOI 10.2147/dddt.s461122 -
Effective and safe pediatric sedation.
Jang YE, Kim JT. · · 2024 · cited 4× · PMID 39069650 · DOI 10.17085/apm.24046
Verify or expand the search:
- PubMed search for NCT04720963
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Remimazolam
Trials testing the same drug.
- NCT07251101 — Hemodynamic Effects of Remimazolam vs Propofol During Robot-assisted Gynecologic Surgery · NA · not yet recruiting
- NCT07459322 — The Use of Remimazolam Versus Dexmedetomidine for Patients Receiving Drug-Induced Sleep Endoscopy · NA · not yet recruiting
- NCT07290205 — Remimazolam NeuroImaging · EARLY_PHASE1 · recruiting
- NCT07269808 — Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration · Phase 3 · recruiting
- NCT06231563 — Ketamine for Veterans With Parkinson's Disease · Phase 2 · recruiting
Other Second Affiliated Hospital of Wenzhou Medical University trials
Trials by the same sponsor.
- NCT07466511 — Effect of Bifidobacterium Breve Supplementation on the Onset and Progression of Idiopathic Scoliosis · NA · not yet recruiting
- NCT07530848 — Perioperative Pharmacokinetics of Anesthetic Drugs and Complications in Overweight and Obese Patients · not yet recruiting
- NCT07346443 — Mechanism Study of G Protein-coupled Receptor 81 in Multiple Organ Dysfunction of Heat Stroke · not yet recruiting
- NCT07353970 — Mechanisms of Prognostic Regulation andPrecision Phenotype Ldentification in Severe Infections Driven by SpecializedPro- · not yet recruiting
- NCT07332793 — Mechanisms of Precise Immune Cell Phenotyping and Prognostic Prediction in Severe Infection · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04720963 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Second Affiliated Hospital of Wenzhou Medical University
- Last refreshed: 8 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04720963.
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