A Phase 4 interventional study of Remimazolam and Distilled water for injection in Sedative; Anxiety Disorder, sponsored by Second Affiliated Hospital of Wenzhou Medical University. Completed at 1 site in China. Open to participants aged 2 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-08.
Sponsored by Second Affiliated Hospital of Wenzhou Medical University · Phase 4, Interventional, and Treatment
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.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 90 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Second Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 133 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
intranasal placebo about 30min before anesthesia induction
Other: Distilled water for injection
intranasal remimazolam about 30min before anesthesia induction
Drug: Remimazolam
intranasal dexmedetomidine about 30min before anesthesia induction
Drug: Dexmedetomidine
intranasal remimazolam
intranasal distilled water for injection
Intranasal dexmedetomidine
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.
Time frame: up to 30 minutes after study drug given
The level of sedation
Ramsay score 1. Patient anxious or agitated or both 2. Patient cooperative, oriented and tranquil 3. Patient responds to commands only 4. A brisk response to a light glabellar tap 5. A sluggish response to a light glabellar tap 6. No response higher scores mean a higher levels of sedation.
Time frame: up to 30 minutes after study drug given
the compliance of study drug given
behavior score 1. Clam and cooperative； 2. Anxious but reassurable; 3. Anxious but not reassurable; 4. 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
Parental separation anxiety scale
A four-point parental separation anxiety scale as follows: 1. Easy separation, 2. Whimpers, but is easily reassured, not clinging, 3. Cries and cannot be easily reassured, but not clinging to parents, 4. 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
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
Time frame: intraoperative, (During inhalation anesthesia induction)
Mask acceptance scale，MAS
Mask acceptance scale，MAS 1. terrified, crying, agitated 2. moderate fear, not calmed with reassurance 3. slight fear of mask, easily calmed 4. 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)
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.
Time frame: Within up to 15-30 minutes after child's first eye opening in the postoperative period
Recovery times
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
Number of children with adverse effects
Number of children with adverse effects 1. Bradycardia and/or hypotension need for hemodynamic support 2. Desaturation is defined as Oxygen desaturation \<90% 3. Any adverse effects requiring interventions
Time frame: Up to 24 hours including preoperative, intraoperative, and postoperative periods
Plan to share: No
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Second Affiliated Hospital of Wenzhou Medical University