Dexmedetomidine Combined With Hydromorphone in Tonsillectomy and Adenoidectomy
- Conditions
- Agitated; State, Acute Reaction to Stress
- Interventions
- Registration Number
- NCT03760809
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
- experienced tonsillectomy and adenoidectomy
- ASA physical status I-II
- weight 12-30 kg
- respiratory disease
- circulatory or nervous system disease
- hepatic dysfunction
- known adverse reactions to hydromophine and dexmedetomidine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group B Dexmedetomidine 1μg／kg Dexmedetomidine(1μg／kg)/hydromophine-based general anesthesia group A Dexmedetomidine 0.5μg／kg Dexmedetomidine(0.5 μg／kg)/hydromophine-based general anesthesia
- Primary Outcome Measures
Name Time Method extubation time 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
Agitation scores 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.coughing score scores at the time point of 15 minutes after extubation 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
Name Time Method
Trial Locations
- Locations (1)
Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China