Dexmedetomidine Combined With Hydromorphone in Tonsillectomy and Adenoidectomy

Eye & ENT Hospital of Fudan University

Status and phase: Completed; Phase 4

Conditions: Agitated; State, Acute Reaction to Stress

Treatments: Drug: Dexmedetomidine 1μg／kg; Drug: Dexmedetomidine 0.5μg／kg

Study type: Interventional

Funder types: Other

Identifiers

NCT03760809

dex-hyd

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 3 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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130 participants in 2 patient groups

group A

Experimental group

Description:

Dexmedetomidine(0.5 μg／kg)/hydromophine-based general anesthesia

Treatment:

Drug: Dexmedetomidine 0.5μg／kg

group B

Experimental group

Description:

Dexmedetomidine(1μg／kg)/hydromophine-based general anesthesia

Treatment:

Drug: Dexmedetomidine 1μg／kg