Intranasal Remimazolam for Premedication in Pediatric Patient

Second Affiliated Hospital of Wenzhou Medical University

Status and phase: Completed; Phase 4

Conditions: Sedative; Anxiety Disorder

Treatments: Other: Distilled water for injection; Drug: Remimazolam; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04720963

SAHoWMU-CR2020-03-114

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 2 to 5 years old

Volunteers: Accepts 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.-

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

group P (Placebo group)

Placebo Comparator group

Description:

intranasal placebo about 30min before anesthesia induction

Treatment:

Other: Distilled water for injection

group R (remimazolam group)

Experimental group

Description:

intranasal remimazolam about 30min before anesthesia induction

Treatment:

Drug: Remimazolam

group D (Dexmedetomine group)

Active Comparator group

Description:

intranasal dexmedetomidine about 30min before anesthesia induction

Treatment:

Drug: Dexmedetomidine