Intranasal Remimazolam for Premedication in Pediatric Patient

Phase 4CompletedNCT04720963

Second Affiliated Hospital of Wenzhou Medical University90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Sedative; Anxiety Disorder

Interventions

Eligibility

Sex: ALLMin age: 2 YearsMax age: 5 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.-

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Intranasal Remimazolam for Premedication in Pediatric Patient

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes