Intranasal Remimazolam for Premedication in Pediatric Patient
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: group P (Placebo group) intranasal placebo 20-30min before anesthesia induction |
Other: Distilled water for injection
intranasal distilled water for injection
|
| Experimental: group R (remimazolam group) intranasal remimazolam 20-30min before anesthesia induction |
Drug: Remimazolam
intranasal remimazolam
|
| Active Comparator: group D (Dexmedetomine group) intranasal dexmedetomidine 20-30min before anesthesia induction |
Drug: Dexmedetomidine
Intranasal dexmedetomidine
|
Outcome Measures
Primary Outcome Measures
- The level of anxiety [up to 20 minutes after study drug given]
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 [up to 20 minutes after study drug given]
The modified observer's assessment of alert /sedation 0 = does not respond to deep stimulus; = does not respond to mild prodding or shaking; = responds only after mild prodding or shaking; = responds only after name is called loudly or repeatedly; = lethargic response to name spoken in normal tone; = responds readily to name spoken in normal tone. higher scores mean a higher levels of sedation.
- The onset time of satisfactory sedation [up to 20 minutes after study drug given]
The onset time of satisfactory sedation, defined as the time from drug administration to the time when the modified observer's assessment of alert /sedation reached 2 point. 0 = does not respond to deep stimulus; = does not respond to mild prodding or shaking; = responds only after mild prodding or shaking; = responds only after name is called loudly or repeatedly; = lethargic response to name spoken in normal tone; = responds readily to name spoken in normal tone.higher scores mean a higher levels of sedation.
- the compliance of study drug given [up to 20 minutes before anesthesia induction]
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 [up to 20 minutes after study drug given]
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 [intraoperative, (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 [intraoperative, (During inhalation anesthesia induction)]
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 [Within up to 15-30 minutes after child's first eye opening in the postoperative period]
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 [Within up to 30 minutes after child's first eye opening in the postoperative period]
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 [Up to 24 hours including preoperative, intraoperative, and postoperative periods]
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
Eligibility Criteria
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;
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other reasons that researchers hold it is not appropriate to participate in this trial.-
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | China |
Sponsors and Collaborators
- Second Affiliated Hospital of Wenzhou Medical University
Investigators
- Study Chair: Huacheng Liu, Second Affiliated Hospital of Wenzhou Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SAHoWMU-CR2020-03-114