A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children

NCT05111431 | Completed Phase 3

• 1 other identifier: HR0171401-302
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the efficacy, and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in children.

Conditions

Preoperative Sedation of Children

Outcome Measures

Primary Outcomes (2)

• Proportion of subjects who meet parent-child separation successful

  within 45 minutes after the beginning of administration

• Proportion of subjects who meet the Ramsay sedation score of 3 at least once within 45 minutes after the beginning of administration

  within 45 minutes after the beginning of administration

Secondary Outcomes (7)

• Proportion of subjects who meet parent-child separation successful within 45 minutes after the beginning of administration

  Within 45 minutes after the beginning of administration

• Time from the beginning of administration to the successful parent-child separation for the first time through study completion，an average of 3 days

  an average of 3 days

• Proportion of subjects whose the Ramsay score is satisfactory at least once within 45 minutes after the beginning of administration

  Within 45 minutes after the beginning of administration

• Time from the beginning of administration to the satisfactory Ramsay score for the first time

  from the beginning of administration to the first successful Ramsay score

• Proportion of subjects whose the UMSS Scale is satisfactory at least once within 45 minutes after the beginning of administration

  within 45 minutes after the beginning of administration

Study Arms (2)

Dexmedetomidine Hydrochloride Nasal Spray

EXPERIMENTAL

Drug: Dexmedetomidine Hydrochloride Nasal Spray

Dexmedetomidine hydrochloride nasal spray blank preparation

PLACEBO COMPARATOR

Drug: Dexmedetomidine hydrochloride nasal spray blank preparation

Interventions

Dexmedetomidine Hydrochloride Nasal Spray DRUG

In the low weight group, the subjects will receive a low dose of dexmedetomidine nasal spray. In the high weight group, the subjects will receive a high dose of dexmedetomidine nasal spray.

Dexmedetomidine Hydrochloride Nasal Spray

Dexmedetomidine hydrochloride nasal spray blank preparation DRUG

In the low weight group, the subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation. In the high weight group, the subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.

Dexmedetomidine hydrochloride nasal spray blank preparation

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Able and willing to provide a written informed consent
• Male or female
• Subjects requiring elective general anesthesia surgery
• Conform to the ASA Physical Status Classification
• Meet the weight standard

You may not qualify if:

• Not suitable for nasal spray
• Pediatric populations requiring special care or court/social welfare supervision
• Subjects who had been under general anesthesia when they were randomized
• Subjects with a history of mental illness and a history of cognitive impairment epilepsy
• Subjects with cardiovascular disease
• Subjects whose hemoglobin is below the lower limit of normal
• Subjects with a history or possibility of a difficult airway
• Abnormal liver function and/or abnormal renal function
• Adrenoceptor agonists or antagonists or analgesics were used before randomization
• Participated in clinical trials (received experimental drugs)
• History of hypersensitivity to drug ingredients or components
• Other circumstances that the investigator judged inappropriate for participation in this clinical trial

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Children's Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100045, China

Location

Related Publications (1)

• Gao J, Wang F, Wang X, Zou X, Liu HC, Song X, Chai X, Jiang R, Zhao P, Zhang J, Wang SY, Ma H, Zhao Z, Wang Q, Zhou N, Bai J, Zhang J. Safety and efficacy of a novel dexmedetomidine nasal spray for pre-anesthetic sedation in children: a randomized, double-blind, placebo-controlled trial. BMC Anesthesiol. 2024 Sep 6;24(1):315. doi: 10.1186/s12871-024-02708-1.

  PMID: 39242499 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dexmedetomidine hydrochloride nasal spray compared with placebo

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 8, 2021
• Study Start: November 24, 2021
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: November 7, 2022

Record last verified: 2021-10

Locations

CN (1)