Intranasal Remimazolam for Premedication in Pediatric Patient

Phase 4

Completed

• Conditions: Sedative; Anxiety Disorder
• Interventions: Other: Distilled water for injection; Drug: Remimazolam; Drug: Dexmedetomidine

• Registration Number: NCT04720963
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

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.

Study Timeline

• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-22
• Study Start: 2021-02-07
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.-

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group P (Placebo group)	Distilled water for injection	intranasal placebo about 30min before anesthesia induction
group R (remimazolam group)	Remimazolam	intranasal remimazolam about 30min before anesthesia induction
group D (Dexmedetomine group)	Dexmedetomidine	intranasal dexmedetomidine about 30min before anesthesia induction

Primary Outcome Measures

Name	Time	Method
The level of anxiety	up to 30 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

Name	Time	Method
The level of sedation	up to 30 minutes after study drug given	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.
the compliance of study drug given	up to 30 minutes before anesthesia induction	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.
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.
Number of children with adverse effects	Up to 24 hours including preoperative, intraoperative, and postoperative periods	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
Parental separation anxiety scale	up to 30 minutes after study drug given	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.
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; 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.
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

Trial Locations

Locations (1)

The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China