Intranasal Remimazolam for Premedication in Pediatric Patient

Sedative; Anxiety Disorder Clinical Trial

Official title:

Intranasal Remimazolam for Premedication in Pediatric Patients: a Double-blinded Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04720963
• Other study ID #: SAHoWMU-CR2020-03-114
• Status: Completed
• Phase: Phase 4
• Start date: February 7, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: September 2023
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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.-

Related Conditions & MeSH terms

• Anxiety Disorders
• Sedative; Anxiety Disorder

Intervention

Drug:
• Remimazolam
intranasal remimazolam

Other:
• Distilled water for injection
intranasal distilled water for injection

Drug:
• Dexmedetomidine
Intranasal dexmedetomidine

Locations

Country	Name	City	State
China	The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	The level of sedation	Ramsay score; Patient anxious or agitated or both; Patient cooperative, oriented and tranquil; Patient responds to commands only; A brisk response to a light glabellar tap; A sluggish response to a light glabellar tap; No response higher scores mean a higher levels of sedation.	up to 30 minutes after study drug given
Secondary	the compliance of study drug given	behavior score; Clam and cooperative; Anxious but reassurable; Anxious but not reassurable; Crying, or resisting The scores of 1 and 2 signified satisfactory compliance, whereas scores of 3 and 4 were classified as poor compliance.	up to 30 minutes before anesthesia induction
Secondary	Parental separation anxiety scale	A four-point parental separation anxiety scale as follows: Easy separation,; Whimpers, but is easily reassured, not clinging,; Cries and cannot be easily reassured, but not clinging to parents,; Crying and clinging to parents. The scores of 1 and 2 signified acceptable separation whereas scores of 3 and 4 were classified as difficult separation.	up to 30 minutes after study drug given
Secondary	The degree of cooperation during inhalation anesthesia induction	Induction Compliance Checklist range from 0 through 10,and lower scores indicate the higher degree of cooperation during inhalation anesthesia induction	intraoperative, (During inhalation anesthesia induction)
Secondary	Mask acceptance scale,MAS	Mask acceptance scale,MAS; terrified, crying, agitated; moderate fear, not calmed with reassurance; slight fear of mask, easily calmed; unafraid, cooperative, accepts mask readily The scores of 3 and 4 signified satisfactory mask acceptable whereas scores of 1 and 2 were classified as poor mask acceptable.	intraoperative, (During inhalation anesthesia induction)
Secondary	Pediatric anesthesia emergence delirium scale,PAEDs	The pediatric anesthesia emergence delirium scale consists of four 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.	Within up to 15-30 minutes after child's first eye opening in the postoperative period
Secondary	Recovery times	The time from discontinuation of sevoflurane to the first open eye of the children and to achieve aldrete=9	Within up to 30 minutes after child's first eye opening in the postoperative period
Secondary	Number of children with adverse effects	Number of children with adverse effects; Bradycardia and/or hypotension need for hemodynamic support; Desaturation is defined as Oxygen desaturation <90%; Any adverse effects requiring interventions	Up to 24 hours including preoperative, intraoperative, and postoperative periods