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Dexmedetomidine Combined With Hydromorphone in Tonsillectomy and Adenoidectomy

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03760809
Recruitment Status : Completed
First Posted : November 30, 2018
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Eye & ENT Hospital of Fudan University

Brief Summary:
Tonsillectomy and adenoidectomy is one of the most common pediatric surgeries, and agitation and severe postoperative pain have been considered a very common complications. Dexmedetomidine mainly inhibits the release of norepinephrine by acting on the α-adrenergic receptor of the brainstem nucleus, which can produce good sedative effects. Hydromorphone has a longer duration of action than fentanyl, and it also has a certain sedative effect. The combination of the two is more conducive to the management of postanesthetic agitation and pain. This study was to compare the effect of different doses of dexmedetomidine combined with hydromorphone in the sedation and analgesia after pediatric tonsillectomy and adenoidectomy.

Condition or disease Intervention/treatment Phase
Agitated; State, Acute Reaction to Stress Drug: Dexmedetomidine 0.5μg/kg Drug: Dexmedetomidine 1μg/kg Phase 4

Detailed Description:

The computer generates random numbers to allocate patients into different group. Trained research staff who are not involved in the study collect the data. The treating clinicians are not blinded to the assignment group.

The primary measurement are pain scores, PAED scores, coughing score ( a 4-point scale:1= no coughing,2=minimal coughing, one or two times, 3= moderate coughing,3-4 times, 4 = severe coughing, more than 5 times), and extubation time. The secondary measurements are the time to discharge from the post-anaesthesia care unit, and the number of postoperative desaturation.

A sample size of 30 was determined by analysis based on the assumption of the decline of extubation time from other similar study and α=0.05,β=0.2.

The continuous variables were presented as means ± SD and the categorical variables were expressed as frequency.

The outcome of interest is extubation time decline.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Different Dose of Dexmedetomidine Combined With Hydromorphone in Children With Tonsillectomy and Adenoidectomy
Actual Study Start Date : January 4, 2019
Actual Primary Completion Date : February 10, 2019
Actual Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids Tonsillitis

Arm Intervention/treatment
Experimental: Dexmedetomidine(0.5 μg/kg)
Dexmedetomidine(0.5 μg/kg)/hydromophine-based general anesthesia
Drug: Dexmedetomidine 0.5μg/kg
Group A received dexmedetomidine 0.5μg/kg (diluted to 100ml,influded in 5 mins at the beginning of the surgery) and hydromophine 0.03 mg/kg as a bolus.
Other Name: Dexmedetomidine Hydrochloride Injection

Experimental: group B
Dexmedetomidine(1μg/kg)/hydromophine-based general anesthesia
Drug: Dexmedetomidine 1μg/kg
Group B received dexmedetomidine 1μg/kg (diluted to 100ml,influded in 5 mins at the beginning of the surgery) and hydromophine 0.03 mg/kg as a bolus.
Other Name: Dexmedetomidine Hydrochloride Injection




Primary Outcome Measures :
  1. extubation time [ Time Frame: duration from the time that patients arrived in PACU to the time of extubation, though study completion, average 40 mins ]
    the time of extubation after surgery

  2. Agitation scores [ Time Frame: scores at the time point of 0 minute after extubation ]

    pediatric anesthesia emergence delirium (PAED) scores included five behaviors:(1)makes eye contact with caregiver,(2) actions are purposeful,(3) aware of surroundings,(4) restless,(5) inconsolable.

    Each behavior was correlated to different degree(4= not at all,3= just a little, 2= quite a bit, 1= very much,0= extremely). The scores for each of the five listed behaviors are added to achieve a total score (maximum score of 20, minimum score of 0). A score of >12 is diagnosed to agitation.


  3. Agitation scores [ Time Frame: scores at the time point of 5 minutes after extubation ]

    pediatric anesthesia emergence delirium (PAED) scores included five behaviors:(1)makes eye contact with caregiver,(2) actions are purposeful,(3) aware of surroundings,(4) restless,(5) inconsolable.

    Each behavior was correlated to different degree(4= not at all,3= just a little, 2= quite a bit, 1= very much,0= extremely). The scores for each of the five listed behaviors are added to achieve a total score (maximum score of 20, minimum score of 0). A score of >12 is diagnosed to agitation.


  4. Agitation scores [ Time Frame: scores at the time point of 10 minutes after extubation ]

    pediatric anesthesia emergence delirium (PAED) scores included five behaviors:(1)makes eye contact with caregiver,(2) actions are purposeful,(3) aware of surroundings,(4) restless,(5) inconsolable.

    Each behavior was correlated to different degree(4= not at all,3= just a little, 2= quite a bit, 1= very much,0= extremely). The scores for each of the five listed behaviors are added to achieve a total score (maximum score of 20, minimum score of 0). A score of >12 is diagnosed to agitation.


  5. Agitation scores [ Time Frame: scores at the time point of 15 minutes after extubation ]

    pediatric anesthesia emergence delirium (PAED) scores included five behaviors:(1)makes eye contact with caregiver,(2) actions are purposeful,(3) aware of surroundings,(4) restless,(5) inconsolable.

    Each behavior was correlated to different degree(4= not at all,3= just a little, 2= quite a bit, 1= very much,0= extremely). The scores for each of the five listed behaviors are added to achieve a total score (maximum score of 20, minimum score of 0). A score of >12 is diagnosed to agitation.


  6. coughing score [ Time Frame: scores at the time point of 0 minute after extubation ]
    a 4-point scale that is used to measure severity of coughing(maximum score of 4, minimum score of 1):1= no coughing,2=minimal coughing, one or two times,3= moderate coughing,3-4 times,4= severe coughing, more than 5 times.

  7. coughing score [ Time Frame: scores at the time point of 5 minutes after extubation ]
    a 4-point scale that is used to measure severity of coughing(maximum score of 4, minimum score of 1):1= no coughing,2=minimal coughing, one or two times,3= moderate coughing,3-4 times,4= severe coughing, more than 5 times.

  8. coughing score [ Time Frame: scores at the time point of 10 minutes after extubation ]
    a 4-point scale that is used to measure severity of coughing(maximum score of 4, minimum score of 1):1= no coughing,2=minimal coughing, one or two times,3= moderate coughing,3-4 times,4= severe coughing, more than 5 times.

  9. coughing score [ Time Frame: scores at the time point of 15 minutes after extubation ]
    a 4-point scale that is used to measure severity of coughing(maximum score of 4, minimum score of 1):1= no coughing,2=minimal coughing, one or two times,3= moderate coughing,3-4 times,4= severe coughing, more than 5 times.



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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • exepericed tonsillectomy and adenoidectomy
  • ASA physical status I-II
  • weight 12-30 kg

Exclusion Criteria:

  • respiratory disease
  • circulatory or nervous system disease
  • hepatic dysfunction
  • known adverse reactions to hydromophine and dexmedetomidine

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): NCT03760809


Locations
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China, Shanghai
Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University
Shanghai, Shanghai, China, 200031
Sponsors and Collaborators
Eye & ENT Hospital of Fudan University
Investigators
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Principal Investigator: e ji Jia, M.D. Eye and ENT Hospital of Fudan University
Publications of Results:
Other Publications:
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Responsible Party: Eye & ENT Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT03760809    
Other Study ID Numbers: dex-hyd
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eye & ENT Hospital of Fudan University:
dexmedetomidine
hydromophine
tonsillectomy and adenoidectomy
Additional relevant MeSH terms:
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Stress Disorders, Traumatic, Acute
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
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