Dexmedetomidine Combined With Hydromorphone in Tonsillectomy and Adenoidectomy
Primary Purpose
Agitated; State, Acute Reaction to Stress
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine 0.5μg/kg
Dexmedetomidine 1μg/kg
Sponsored by
About this trial
This is an interventional supportive care trial for Agitated; State, Acute Reaction to Stress focused on measuring dexmedetomidine, hydromophine, tonsillectomy and adenoidectomy
Eligibility Criteria
Inclusion Criteria:
- experienced 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
Sites / Locations
- Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
group A
group B
Arm Description
Dexmedetomidine(0.5 μg/kg)/hydromophine-based general anesthesia
Dexmedetomidine(1μg/kg)/hydromophine-based general anesthesia
Outcomes
Primary Outcome Measures
extubation time
the time of extubation after surgery
Agitation scores
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.
Agitation scores
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.
Agitation scores
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.
Agitation scores
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.
coughing score
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.
coughing score
a 9-point scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4 times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times, 9= laryngospasm).
coughing score
a 9-point scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4 times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times, 9= laryngospasm).
coughing score
a 9-point scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4 times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times, 9= laryngospasm)
Secondary Outcome Measures
Full Information
NCT ID
NCT03760809
First Posted
November 20, 2018
Last Updated
June 17, 2021
Sponsor
Eye & ENT Hospital of Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT03760809
Brief Title
Dexmedetomidine Combined With Hydromorphone in Tonsillectomy and Adenoidectomy
Official Title
The Effect of Different Dose of Dexmedetomidine Combined With Hydromorphone in Children With Tonsillectomy and Adenoidectomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 4, 2019 (Actual)
Primary Completion Date
February 10, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eye & ENT Hospital of Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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 observer who only stayed in PACU was blinded to the allocation and responsible to record the data.
The primary measurement are pain scores, PAED scores, coughing was evaluated on a 9-point scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4 times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times, 9= laryngospasm), 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 57 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitated; State, Acute Reaction to Stress
Keywords
dexmedetomidine, hydromophine, tonsillectomy and adenoidectomy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Experimental
Arm Description
Dexmedetomidine(0.5 μg/kg)/hydromophine-based general anesthesia
Arm Title
group B
Arm Type
Experimental
Arm Description
Dexmedetomidine(1μg/kg)/hydromophine-based general anesthesia
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine 0.5μg/kg
Other Intervention Name(s)
Dexmedetomidine Hydrochloride Injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine 1μg/kg
Other Intervention Name(s)
Dexmedetomidine Hydrochloride Injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
extubation time
Description
the time of extubation after surgery
Time Frame
duration from the time that patients arrived in PACU to the time of extubation, though study completion, average 40 mins
Title
Agitation scores
Description
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.
Time Frame
scores at the time point of 0 minute after extubation
Title
Agitation scores
Description
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.
Time Frame
scores at the time point of 5 minutes after extubation
Title
Agitation scores
Description
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.
Time Frame
scores at the time point of 10 minutes after extubation
Title
Agitation scores
Description
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.
Time Frame
scores at the time point of 15 minutes after extubation
Title
coughing score
Description
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.
Time Frame
scores at the time point of 0 minute after extubation
Title
coughing score
Description
a 9-point scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4 times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times, 9= laryngospasm).
Time Frame
scores at the time point of 5 minutes after extubation
Title
coughing score
Description
a 9-point scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4 times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times, 9= laryngospasm).
Time Frame
scores at the time point of 10 minutes after extubation
Title
coughing score
Description
a 9-point scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4 times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times, 9= laryngospasm)
Time Frame
scores at the time point of 15 minutes after extubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
experienced 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
e ji Jia, M.D.
Organizational Affiliation
Eye and ENT Hospital of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20610555
Citation
Olutoye OA, Glover CD, Diefenderfer JW, McGilberry M, Wyatt MM, Larrier DR, Friedman EM, Watcha MF. The effect of intraoperative dexmedetomidine on postoperative analgesia and sedation in pediatric patients undergoing tonsillectomy and adenoidectomy. Anesth Analg. 2010 Aug;111(2):490-5. doi: 10.1213/ANE.0b013e3181e33429. Epub 2010 Jul 7.
Results Reference
background
PubMed Identifier
11442853
Citation
Brown KA. What we don't know about childhood obstructive sleep apnoea. Paediatr Anaesth. 2001 Jul;11(4):385-9. doi: 10.1046/j.1460-9592.2001.00719.x. No abstract available.
Results Reference
result
PubMed Identifier
20705788
Citation
Patel A, Davidson M, Tran MC, Quraishi H, Schoenberg C, Sant M, Lin A, Sun X. Dexmedetomidine infusion for analgesia and prevention of emergence agitation in children with obstructive sleep apnea syndrome undergoing tonsillectomy and adenoidectomy. Anesth Analg. 2010 Oct;111(4):1004-10. doi: 10.1213/ANE.0b013e3181ee82fa. Epub 2010 Aug 12.
Results Reference
result
PubMed Identifier
26332857
Citation
Hauber JA, Davis PJ, Bendel LP, Martyn SV, McCarthy DL, Evans MC, Cladis FP, Cunningham S, Lang RS, Campbell NF, Tuchman JB, Young MC. Dexmedetomidine as a Rapid Bolus for Treatment and Prophylactic Prevention of Emergence Agitation in Anesthetized Children. Anesth Analg. 2015 Nov;121(5):1308-15. doi: 10.1213/ANE.0000000000000931.
Results Reference
result
PubMed Identifier
34627829
Citation
Yi W, Li J, Zhuang Y, Wan L, Li W, Jia J. The effect of two different doses of dexmedetomidine to prevent emergence agitation in children undergoing adenotonsillectomy: a randomized controlled trial. Braz J Anesthesiol. 2022 Jan-Feb;72(1):63-68. doi: 10.1016/j.bjane.2021.08.019. Epub 2021 Oct 8.
Results Reference
derived
Learn more about this trial
Dexmedetomidine Combined With Hydromorphone in Tonsillectomy and Adenoidectomy
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