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

Chinese Academy of Medical Sciences & Peking Union Medical College logo

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

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

Trial contacts and locations

1

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Central trial contact

Bo Zhu, MD

Data sourced from clinicaltrials.gov

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