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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-23

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dexmedetomidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Sufen

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

low dose of dexmedetomidine with sufentanil

Intervention Type DRUG

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)

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

Group Type EXPERIMENTAL

high dose of dexmedetomidine with sufentanil

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type 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)

Intervention Type DRUG

Other Intervention Names

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Sufen with low DEX Sufen with high DEX

Eligibility Criteria

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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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No