An interventional study of low dose of dexmedetomidine with sufentanil and high dose of dexmedetomidine with sufentanil in Dexmedetomidine, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 1 Year to 14 Years. Per ClinicalTrials.gov, last updated 2024-11-21.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment
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.
Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 473 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
PCIA: continue with 0.05ug/kg/h sufentanil, 0.05ug/kg sufentainil bolus
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
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
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)
Also known as: Sufen with low DEX
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)
Also known as: Sufen with high DEX
Postoperative opioid analgesic dosage
the total opioid consumption in PCIA postoperatively
Time frame: 48 hours postoperatively
Intraoperative opioid analgesic dosage
Intraoperative opioid analgesic dosage
Time frame: Intraoperative
Effective pressing times of PCIA
extract the data from the electric analgesic pump
Time frame: 48 hours postoperatively
Total pressing times of PCIA
extract the data from the electric analgesic pump
Time frame: 48 hours postoperatively
Remedial analgesics dosage
extract the data from the followup
Time frame: 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.
Time frame: 48 hours postoperatively
LOS
the length of stay
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 72 hours postoperatively
Vomiting
the times of vomiting
Time frame: 4 hours postoperatively
Vomiting
the times of vomiting
Time frame: 8 hours postoperatively
Vomiting
the times of vomiting
Time frame: 24 hours postoperatively
Vomiting
the times of vomiting
Time frame: 48 hours postoperatively
Vomiting
the times of vomiting
Time frame: 72 hours postoperatively
Plan to share: No
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This study is status unknown, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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