Dexmedetomidine
Conditions
Keywords
dexmedetomidine, pediatric anesthesia, patient-control analgesia, scoliosis orthopedics
Brief summary
The primary purpose of this three-arm single center, randomized, subject and assessor blind, controlled clinical study is to evaluate the effect of dexmedetomidine on patient-controlled intravenous analgesia after pediatric scoliosis orthopedics.
Detailed description
The study is a single center, randomized, subject and assessor blinded, controlled clinical study. Children who meet the inclusion/exclusion criteria will be evaluated. The patients will use a postoperative analgesic pump which is named as patient-control-analgesia (PCA) until the end of surgery with different dose of drugs. The control group will be set as using sufentanil only (0.05ug/kg/h infusion and 0.05ug/kg bolus). The experimental group will use sufentanil combined with different doses of dexmedetomidine. Low dose of dexmedetomidine PCA formula is 0.05ug/kg/h sufentanil with 0.05ug/kg/h dexmedetomidine infusion and 0.05ug/kg sufentanil with 0.05ug/kg dexmedetomidine bolus. High dose of dexmedetomidine PCA formula is 0.05ug/kg/h sufentanil with 0.1ug/kg/h dexmedetomidine infusion and 0.05ug/kg sufentanil with 0.1ug/kg dexmedetomidine bolus. Then patients will be followed until they discharge. The purpose of this trial is to evaluate the effect of of dexmedetomidine on patient-controlled intravenous analgesia after pediatric scoliosis orthopedics.
Interventions
DRUGlow dose of dexmedetomidine with sufentanil
low dose of dexmedetomidine in PCIA (0.05ug/kg/h sufentanil with 0.05ug/kg/h dexmedetomidine infusion, 0.05ug/kg sufentanil with 0.05ug/kg dexmedetomidine bolus)
DRUGhigh dose of dexmedetomidine with sufentanil
high dose of dexmedetomidine in PCIA (0.05ug/kg/h sufentanil with 0.1ug/kg/h dexmedetomidine infusion, 0.05ug/kg sufentanil with 0.1ug/kg dexmedetomidine bolus)
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Aged 1-14 years scheduled to receive scoliosis orthopedics under general anesthesia; * Weight is ±15% of standard weight (standard weight (kg) = height (cm) -100); * Informed consent signed.
Exclusion criteria
* Allergy to dexmedetomidine; * Obvious abnormalities of heart, lung, liver, renal function and endocrine function; * Patients who can not cooperate with this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative opioid analgesic dosage | 48 hours postoperatively | the total opioid consumption in PCIA postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effective pressing times of PCIA | 48 hours postoperatively | extract the data from the electric analgesic pump |
| Total pressing times of PCIA | 48 hours postoperatively | extract the data from the electric analgesic pump |
| Remedial analgesics dosage | 48 hours postoperatively | extract the data from the followup |
| postoperative pain | 48 hours postoperatively | using VAS method to evaluate pain status. 0 score refers to comfort, 10 score refers to excruciating pain. Higher scores mean a worse outcome. |
| Intraoperative opioid analgesic dosage | Intraoperative | Intraoperative opioid analgesic dosage |
| Patient satisfaction | 48 hours postoperatively | patients' and relatives' satisfaction, 0 score refers to dissatisfaction, 10 score refers to satisfaction. Higher scores mean a better outcome. |
| Nausea | 4 hours postoperatively | Using VRS (Verbal Rating Scales) to evaluate the degree of nausea. 0 score refers to comfort, 10 score refers to excruciating nause. Higher scores mean a worse outcome. |
| Sedation | 4 hours postoperatively | Using RSAS(Riker Sedation Agitation Scale) to evaluate the status of sedation. 1 score is not aroused, 2 score is very calm, 3 score is calm, 4 score is quiet cooperation, 5 is mildly agitated, 6 score was moderate agitation, and 7 score was severe agitation. Higher and lower scores both mean a worse outcome. |
| Vomiting | 4 hours postoperatively | the times of vomiting |
| LOS | through study completion, an average of 7 days postoperatively. | the length of stay |
Countries
China
Outcome results
None listed