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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sufen | No Intervention | PCIA: continue with 0.05ug/kg/h sufentanil, 0.05ug/kg sufentainil bolus | |
| Sufen with low DEX | Experimental | 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 |
|
| Sufen with high DEX | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low dose of dexmedetomidine with sufentanil | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative opioid analgesic dosage | the total opioid consumption in PCIA postoperatively | 48 hours postoperatively |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuguang Huang, MD | Anesthesiology of PUMCH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| high dose of dexmedetomidine with sufentanil | Drug | 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) |
|
|
| 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 |
| D005283 |
| Fentanyl |
| D010880 | Piperidines |