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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Active, not recruiting

Conditions: Dexmedetomidine

Treatments: Drug: low dose of dexmedetomidine with sufentanil; Drug: high dose of dexmedetomidine with sufentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT05249153

ZS-2546

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 1 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 3 patient groups

Sufen

No Intervention group

Description:

PCIA: continue with 0.05ug/kg/h sufentanil, 0.05ug/kg sufentainil bolus

Sufen with low DEX

Experimental group

Description:

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

Treatment:

Drug: low dose of dexmedetomidine with sufentanil

Sufen with high DEX

Experimental group

Description:

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

Treatment:

Drug: high dose of dexmedetomidine with sufentanil