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Intranasal Remimazolam for Premedication in Pediatric Patient

Primary Purpose

Sedative; Anxiety Disorder

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Remimazolam
Distilled water for injection
Dexmedetomidine
Sponsored by
Second Affiliated Hospital of Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sedative; Anxiety Disorder focused on measuring remimazolam

Eligibility Criteria

2 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

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.-

Sites / Locations

  • The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

group P (Placebo group)

group R (remimazolam group)

group D (Dexmedetomine group)

Arm Description

intranasal placebo about 30min before anesthesia induction

intranasal remimazolam about 30min before anesthesia induction

intranasal dexmedetomidine about 30min before anesthesia induction

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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
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.
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.
Recovery times
The time from discontinuation of sevoflurane to the first open eye of the children and to achieve aldrete≥9
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

Full Information

First Posted
January 11, 2021
Last Updated
September 6, 2023
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04720963
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 7, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Wenzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedative; Anxiety Disorder
Keywords
remimazolam

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group P (Placebo group)
Arm Type
Placebo Comparator
Arm Description
intranasal placebo about 30min before anesthesia induction
Arm Title
group R (remimazolam group)
Arm Type
Experimental
Arm Description
intranasal remimazolam about 30min before anesthesia induction
Arm Title
group D (Dexmedetomine group)
Arm Type
Active Comparator
Arm Description
intranasal dexmedetomidine about 30min before anesthesia induction
Intervention Type
Drug
Intervention Name(s)
Remimazolam
Intervention Description
intranasal remimazolam
Intervention Type
Other
Intervention Name(s)
Distilled water for injection
Intervention Description
intranasal distilled water for injection
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Intranasal dexmedetomidine
Primary Outcome Measure Information:
Title
The level of anxiety
Description
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.
Time Frame
up to 30 minutes after study drug given
Secondary Outcome Measure Information:
Title
The level of sedation
Description
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.
Time Frame
up to 30 minutes after study drug given
Title
the compliance of study drug given
Description
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.
Time Frame
up to 30 minutes before anesthesia induction
Title
Parental separation anxiety scale
Description
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.
Time Frame
up to 30 minutes after study drug given
Title
The degree of cooperation during inhalation anesthesia induction
Description
Induction Compliance Checklist range from 0 through 10,and lower scores indicate the higher degree of cooperation during inhalation anesthesia induction
Time Frame
intraoperative, (During inhalation anesthesia induction)
Title
Mask acceptance scale，MAS
Description
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.
Time Frame
intraoperative, (During inhalation anesthesia induction)
Title
Pediatric anesthesia emergence delirium scale，PAEDs
Description
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.
Time Frame
Within up to 15-30 minutes after child's first eye opening in the postoperative period
Title
Recovery times
Description
The time from discontinuation of sevoflurane to the first open eye of the children and to achieve aldrete≥9
Time Frame
Within up to 30 minutes after child's first eye opening in the postoperative period
Title
Number of children with adverse effects
Description
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
Time Frame
Up to 24 hours including preoperative, intraoperative, and postoperative periods

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: with American Society of Anesthesiologists (ASA) physical status I or II； aged 2-5 years； children with weight for age within the normal range were scheduled surgery with general anesthesia Exclusion Criteria: Children who had gastrointestinal,Cardiovascular or endocrine dysfunction; contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to either dexmedetomidine or remimazolam; with any nasal pathology,organ dysfunction; recently respiratory infection, mental disorder; other reasons that researchers hold it is not appropriate to participate in this trial.-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huacheng Liu
Organizational Affiliation
Second Affiliated Hospital of Wenzhou Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Intranasal Remimazolam for Premedication in Pediatric Patient

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