Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04135014
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital of Wenzhou Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anxiety Drug: Midazolam Drug: Dexmedetomidine Drug: Midazolam and Dexmedetomidine Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Intranasal Dexmedetomidine or Oral Midazolam Alone Versus Combination With Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients Undergoing Minor Surgery
Actual Study Start Date : October 25, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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 Name: 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 Name: 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 Name: combination with intranasal dexmedetomidine and oral midazolam




Primary Outcome Measures :
  1. The degree of cooperation during inhalation anesthesia induction [ Time Frame: 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


Secondary Outcome Measures :
  1. Anxiety before induction of anesthesia [ Time Frame: Before preoperative medication ]

    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.


  2. The level of sedation [ Time Frame: Each 10 minutes during the preoperative period ]

    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.


  3. The onset time of satisfactory sedation [ Time Frame: During the preoperative period ]

    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.


  4. Parental separation anxiety scale [ Time Frame: During the preoperative period ]

    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.


  5. Recovery times [ Time Frame: 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

  6. Pediatric anesthesia emergence delirium [ Time Frame: 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.


  7. Number of children with adverse effects [ Time Frame: 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. Salivation
    4. Any adverse effects requiring interventions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135014


Contacts
Layout table for location contacts
Contact: Huacheng Liu 18957755138 huachengliu@163.com
Contact: Yuhang Cai 18815091585 838097626@qq.com

Locations
Layout table for location information
China, Zhejiang
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China
Sponsors and Collaborators
Second Affiliated Hospital of Wenzhou Medical University
Investigators
Layout table for investigator information
Principal Investigator: Huacheng Liu Second Affiliated Hospital of Wenzhou Medical University
Principal Investigator: Yuhang Cai Second Affiliated Hospital of Wenzhou Medical University
Layout table for additonal information
Responsible Party: Second Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT04135014    
Other Study ID Numbers: SAHoWMU-CR2019-03-111
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Midazolam
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents