Clinical trial NCT04720963: Intranasal Remimazolam for Premedication in Pediatric Patient
Official title: Intranasal Remimazolam for Premedication in Pediatric Patients: a Double-blinded Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sedative; Anxiety Disorder
Keywords: remimazolam
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 90
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: children aged 2-5 years old were randomly allocated into three equal groups based on the premedication routes: Group R with intranasal remimazolam, Group D with intranasal dexmedetomidine and Group P with intranasal placebo, respectively.

Eligibility criteria: Inclusion Criteria:

1. with American Society of Anesthesiologists (ASA) physical status I or II；
2. aged 2-5 years；
3. children with weight for age within the normal range
4. were scheduled surgery with general anesthesia

Exclusion Criteria:

1. Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;
2. contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to either dexmedetomidine or remimazolam;
3. with any nasal pathology,organ dysfunction;
4. recently respiratory infection, mental disorder;
5. other reasons that researchers hold it is not appropriate to participate in this trial.-

Primary outcomes:
measure: The level of anxiety
timeFrame: up to 30 minutes after study drug given
Secondary outcomes:
measure: The level of sedation
timeFrame: up to 30 minutes after study drug given
measure: the compliance of study drug given
timeFrame: up to 30 minutes before anesthesia induction
measure: Parental separation anxiety scale
timeFrame: up to 30 minutes after study drug given
measure: The degree of cooperation during inhalation anesthesia induction
timeFrame: intraoperative, (During inhalation anesthesia induction)
measure: Mask acceptance scale，MAS
timeFrame: intraoperative, (During inhalation anesthesia induction)
measure: Pediatric anesthesia emergence delirium scale，PAEDs
timeFrame: Within up to 15-30 minutes after child's first eye opening in the postoperative period
measure: Recovery times
timeFrame: Within up to 30 minutes after child's first eye opening in the postoperative period
measure: Number of children with adverse effects
timeFrame: Up to 24 hours including preoperative, intraoperative, and postoperative periods
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Wenzhou Medical University
name: Huacheng Liu
role: STUDY_CHAIR
References: