NCT04720963|CompletedPhase 4
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Sponsor study identifier
interventional
90
1 country
1
Study Start
February 7, 2021
Actual (reported)Primary Completion
February 28, 2022
Actual (reported)Study Completion
February 28, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 11, 2021
Actual (reported)January 22, 2021
Actual (reported)February 7, 2021
Actual (reported)February 28, 2022
Actual (reported)February 28, 2022
Actual (reported)The level of anxiety
The Modified Yale Preoperative Anxiety Scale: The 22-item measure has five behavioural categories: activity, emotional expressivity, alertness and arousal, vocalizations, and interaction with parents. Total scores range from 23.33 through 100 with higher scores indicating greater anxiety.
up to 30 minutes after study drug given
The level of sedation
up to 30 minutes after study drug given
the compliance of study drug given
up to 30 minutes before anesthesia induction
Parental separation anxiety scale
up to 30 minutes after study drug given
The degree of cooperation during inhalation anesthesia induction
intraoperative, (During inhalation anesthesia induction)
Mask acceptance scale，MAS
intraoperative, (During inhalation anesthesia induction)
intranasal placebo about 30min before anesthesia induction
intranasal remimazolam about 30min before anesthesia induction
intranasal dexmedetomidine about 30min before anesthesia induction
intranasal remimazolam
intranasal distilled water for injection
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Cai YH, Wang CY, Fang YB, Ma HY, Gao YQ, Wang Z, Wu J, Lin H, Liu HC. Preoperative Anxiolytic and Sedative Effects of Intranasal Remimazolam and Dexmedetomidine: A Randomized Controlled Clinical Study in Children Undergoing General Surgeries. Drug Des Devel Ther. 2024 May 17;18:1613-1625. doi: 10.2147/DDDT.S461122. eCollection 2024.
Huacheng Liu
Second Affiliated Hospital of Wenzhou Medical University
90 participants (actual enrollment reported by the registry).
First Submitted
January 11, 2021
First Posted
January 22, 2021
Study Start
February 7, 2021
Actual (reported)Intranasal dexmedetomidine
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
February 28, 2022
Actual (reported)Study Completion
February 28, 2022
Actual (reported)Last Updated
September 8, 2023
Record last verified: 2023-09
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Source: ClinicalTrials.gov.
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