Dexmedetomidine and Sufentanil Effect in PCA on Pediatric Patients Undergoing Scoliosis Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Combination of Dexmedetomidine and Sufentanil in Patient-controlled Intravenous Analgesia on Pediatric Patients Undergoing Scoliosis Surgery

Conditions
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Dexmedetomidine

Intervention / Treatment
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* Drug: low dose of dexmedetomidine with sufentanil
* Drug: high dose of dexmedetomidine with sufentanil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Sufen<br>PCIA: continue with 0.05ug/kg/h sufentanil, 0.05ug/kg sufentainil bolus | |
| Experimental: Sufen with low DEX<br>PCIA: continue with 0.05ug/kg/h sufentanil and 0.05ug/kg/h dexmedetomidine, 0.05ug/kg/h sufentanil and 0.05ug/kg/h dexmedetomidine bolus | Drug: low dose of dexmedetomidine with sufentanil<br>* 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)<br>* Other names: Sufen with low DEX;|
| Experimental: Sufen with high DEX<br>PCIA: continue with 0.05ug/kg/h sufentanil and 0.1ug/kg/h dexmedetomidine, 0.05ug/kg/h sufentanil and 0.1ug/kg/h dexmedetomidine bolus | Drug: high dose of dexmedetomidine with sufentanil<br>* 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)<br>* Other names: Sufen with high DEX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative opioid analgesic dosage | the total opioid consumption in PCIA postoperatively | 48 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative opioid analgesic dosage | Intraoperative opioid analgesic dosage | Intraoperative | 
| Effective pressing times of PCIA | extract the data from the electric analgesic pump | 48 hours postoperatively | 
| Total pressing times of PCIA | extract the data from the electric analgesic pump | 48 hours postoperatively | 
| Remedial analgesics dosage | extract the data from the followup | 48 hours postoperatively | 
| postoperative pain | using VAS method to evaluate pain status. 0 score refers to comfort, 10 score refers to excruciating pain. Higher scores mean a worse outcome. | 48 hours postoperatively | 
| LOS | the length of stay | through study completion, an average of 7 days postoperatively. | 
| Patient satisfaction | patients' and relatives' satisfaction, 0 score refers to dissatisfaction, 10 score refers to satisfaction. Higher scores mean a better outcome. | 48 hours postoperatively | 
| Nausea | 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. | 4 hours postoperatively | 
| Nausea | 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. | 8 hours postoperatively | 
| Nausea | 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. | 24 hours postoperatively | 
| Nausea | 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. | 48 hours postoperatively | 
| Nausea | 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. | 72 hours postoperatively | 
| Sedation | 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. | 4 hours postoperatively | 
| Sedation | 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. | 8 hours postoperatively | 
| Sedation | 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. | 24 hours postoperatively | 
| Sedation | 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. | 48 hours postoperatively | 
| Sedation | 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. | 72 hours postoperatively | 
| Vomiting | the times of vomiting | 4 hours postoperatively | 
| Vomiting | the times of vomiting | 8 hours postoperatively | 
| Vomiting | the times of vomiting | 24 hours postoperatively | 
| Vomiting | the times of vomiting | 48 hours postoperatively | 
| Vomiting | the times of vomiting | 72 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexmedetomidine, pediatric anesthesia, patient-control analgesia, scoliosis orthopedics