Combination With Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients

Intranasal Dexmedetomidine or Oral Midazolam Alone Versus Combination With Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients Undergoing Minor Surgery

Children tend to anxiety and even fear before survey. And this kind of anxiety will not result in the forced induction of anesthesia, but also may increase the incidence of postoperative agitation in children, even lead to postoperative behavior changes.Currently,Oral midazolam or intranasal dexmedetomidine alone is commonly used as a preoperative regimen, but the clinical effects of each single-use are not satisfactory. In the investigators' study，the researchers conducted the current study to investigate whether dexmedetomidine combined with midazolam can increase the rate of satisfactory anesthesia induction in pediatric patients and achieve better sedative effect.

Study Overview

• Status: Unknown
• Conditions: Anxiety
• Intervention / Treatment: Drug: Midazolam; Drug: Dexmedetomidine; Drug: Midazolam and Dexmedetomidine

Detailed Description

A trained member of the research team obtained a baseline The Modified Yale Preoperative Anxiety Scale(mYPAS) after obtaining consent. And corresponding study medication is administered about 30-40 minutes before the anesthesia induction.Vital signs were measured every 5 min after study medication administration.The sedation scores of the children were recorded with University of Michigan Sedation Scale (UMSS) every 10 minutes.The onset time of satisfactory sedation and parental separation anxiety scale was noted.Then recorded the degree of cooperation during inhalation anesthesia induction and recovery times.Moreover, recorded the pediatric anesthesia emergence delirium scale (PAED) during the recovery period.

• Study Type: Interventional
• Enrollment (Anticipated): 138
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China
      • Recruiting
      • The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. with American Society of Anesthesiologists (ASA) physical status I or II；
2. aged 2-6 years；
3. children with weight for age within the normal range
4. were scheduled lower abdominal and perineal surgery with an expected operation time shorter than 30 minutes.

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 midazolam;
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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Midazolam; Patients were assigned to receive oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table.	Drug: Midazolam; oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table.; Other Names: oral midazolam
Experimental: Dexmedetomidine; Patients were assigned to receive intranasal dexmedetomidine 2ug/kg approximately 30-40 minutes before surgery using a computer-generated random number table.	Drug: Dexmedetomidine; intranasal dexmedetomidine 2µg.kg-1 approximately 30-40 mins before surgery using a computer-generated random number table.; Other Names: intranasal dexmedetomidine
Experimental: Midazolam and Dexmedetomidine; Patients were assigned to receive intranasal dexmedetomidine 1ug.kg-1 and oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table.	Drug: Midazolam and Dexmedetomidine; oral midazolam 0.5mg.kg-1 and intranasal dexmedetomidine 1ug.kg-1 approximately 30-40 mins before surgery using a computer-generated random number table.; Other Names: combination with intranasal dexmedetomidine and oral midazolam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	During inhalation anesthesia induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery times	The time from discontinuation of sevoflurane to the first open eye of the children and to achieve aldrete≥9	Within up to 30 minutes after child's first eye opening in the postoperative period
Anxiety before induction of anesthesia	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.	Before preoperative medication
The level of sedation	University of Michigan Sedation Scale: 0 -Awake/Alert 1 -Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds. 2- Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation. 3 - Deeply Sedated: Deep sleep, arousable only with significant physical stimulation. 4 - Unarousable. higher scores mean a higher levels of sedation.	Each 10 minutes during the preoperative period
The onset time of satisfactory sedation	The onset time of satisfactory sedation, defined as the time from drug administration to the time when the University of Michigan Sedation Scale reached two points. University of Michigan Sedation Scale: 0 -Awake/Alert 1 -Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds. 2- Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation. 3 - Deeply Sedated: Deep sleep, arousable only with significant physical stimulation. 4 - Unarousable. higher scores mean a higher levels of sedation.	During the preoperative period
Parental separation anxiety scale	A four-point parental separation anxiety scale as follows: -Easy separation,; -Whimpers, but is easily reassured, not clinging,; - Cries and cannot be easily reassured, but not clinging to parents,; - 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.	During the preoperative period
Pediatric anesthesia emergence delirium	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.	Within up to 15-30 minutes after child's first eye opening in the postoperative period
Number of children with adverse effects	Number of children with adverse effects; Bradycardia and/or hypotension need for hemodynamic support; Desaturation is defined as Oxygen desaturation <90%; Salivation; Any adverse effects requiring interventions	Up to 24 hours including preoperative, intraoperative, and postoperative periods

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University
• Investigators: Principal Investigator: Huacheng Liu, Second Affiliated Hospital of Wenzhou Medical University; Principal Investigator: Yuhang Cai, Second Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2019
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: October 17, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Actual): November 5, 2019
• Last Update Submitted That Met QC Criteria: November 3, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Dexmedetomidine
• Other Study ID Numbers: SAHoWMU-CR2019-03-111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes