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

NCT05249153 | Active Not Recruiting DMC

• 1 other identifier: ZS-2546
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Dexmedetomidine

Keywords

dexmedetomidine; pediatric anesthesia; patient-control analgesia; scoliosis orthopedics

Outcome Measures

Primary Outcomes (1)

• Postoperative opioid analgesic dosage

  the total opioid consumption in PCIA postoperatively

  48 hours postoperatively

Secondary Outcomes (22)

• Intraoperative opioid analgesic dosage

  Intraoperative

• Effective pressing times of PCIA

  48 hours postoperatively

• Total pressing times of PCIA

  48 hours postoperatively

• Remedial analgesics dosage

  48 hours postoperatively

• postoperative pain

  48 hours postoperatively

Study Arms (3)

Sufen

NO INTERVENTION

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

Sufen with low DEX

EXPERIMENTAL

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

Sufen with high DEX

EXPERIMENTAL

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

Interventions

low dose of dexmedetomidine with sufentanil 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)

Also known as: Sufen with low DEX

Sufen with low DEX

high dose of dexmedetomidine with sufentanil 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)

Also known as: Sufen with high DEX

Sufen with high DEX

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Allergy to dexmedetomidine;
• Obvious abnormalities of heart, lung, liver, renal function and endocrine function;
• Patients who can not cooperate with this trial.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Interventions

Dexmedetomidine; Sufentanil

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fentanyl; Piperidines

Study Officials

• Yuguang Huang, MD

  Anesthesiology of PUMCH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 21, 2022
• Study Start: September 23, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)