Clinical trial NCT05249153: Dexmedetomidine and Sufentanil Effect in PCA on Pediatric Patients Undergoing Scoliosis Surgery
Official title: The Effect of Combination of Dexmedetomidine and Sufentanil in Patient-controlled Intravenous Analgesia on Pediatric Patients Undergoing Scoliosis Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dexmedetomidine
Keywords: dexmedetomidine
pediatric anesthesia
patient-control analgesia
scoliosis orthopedics
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 84
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Postoperative opioid analgesic dosage
timeFrame: 48 hours postoperatively
Secondary outcomes:
measure: Intraoperative opioid analgesic dosage
timeFrame: Intraoperative
measure: Effective pressing times of PCIA
timeFrame: 48 hours postoperatively
measure: Total pressing times of PCIA
timeFrame: 48 hours postoperatively
measure: Remedial analgesics dosage
timeFrame: 48 hours postoperatively
measure: postoperative pain
timeFrame: 48 hours postoperatively
measure: LOS
timeFrame: through study completion, an average of 7 days postoperatively.
measure: Patient satisfaction
timeFrame: 48 hours postoperatively
measure: Nausea
timeFrame: 4 hours postoperatively
measure: Nausea
timeFrame: 8 hours postoperatively
measure: Nausea
timeFrame: 24 hours postoperatively
measure: Nausea
timeFrame: 48 hours postoperatively
measure: Nausea
timeFrame: 72 hours postoperatively
measure: Sedation
timeFrame: 4 hours postoperatively
measure: Sedation
timeFrame: 8 hours postoperatively
measure: Sedation
timeFrame: 24 hours postoperatively
measure: Sedation
timeFrame: 48 hours postoperatively
measure: Sedation
timeFrame: 72 hours postoperatively
measure: Vomiting
timeFrame: 4 hours postoperatively
measure: Vomiting
timeFrame: 8 hours postoperatively
measure: Vomiting
timeFrame: 24 hours postoperatively
measure: Vomiting
timeFrame: 48 hours postoperatively
measure: Vomiting
timeFrame: 72 hours postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Anesthesiology of PUMCH
name: Yuguang Huang, MD
role: STUDY_CHAIR
References: