DEX: Dexmedetomidine and Sufentanil Effect in PCA on Pediatric Patients Undergoing Scoliosis Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Sufen PCIA: continue with 0.05ug/kg/h sufentanil, 0.05ug/kg sufentainil bolus |
|
| Experimental: Sufen with low DEX 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
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)
Other Names:
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| Experimental: Sufen with high DEX 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
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)
Other Names:
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Outcome Measures
Primary Outcome Measures
- Postoperative opioid analgesic dosage [48 hours postoperatively]
the total opioid consumption in PCIA postoperatively
Secondary Outcome Measures
- Intraoperative opioid analgesic dosage [Intraoperative]
Intraoperative opioid analgesic dosage
- 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.
- LOS [through study completion, an average of 7 days postoperatively.]
the length of stay
- 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.
- Nausea [8 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.
- Nausea [24 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.
- Nausea [48 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.
- Nausea [72 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.
- Sedation [8 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.
- Sedation [24 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.
- Sedation [48 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.
- Sedation [72 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
- Vomiting [8 hours postoperatively]
the times of vomiting
- Vomiting [24 hours postoperatively]
the times of vomiting
- Vomiting [48 hours postoperatively]
the times of vomiting
- Vomiting [72 hours postoperatively]
the times of vomiting
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking Union Medical College Hospital | Beijing | Beijing | China | 100730 |
Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
- Study Chair: Yuguang Huang, MD, Anesthesiology of PUMCH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZS-2546