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

Not Applicable

Active, not recruiting

• Conditions: Dexmedetomidine
• Interventions: Drug: high dose of dexmedetomidine with sufentanil; Drug: low dose of dexmedetomidine with sufentanil

• Registration Number: NCT05249153
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study Start: 2020-09-23
• Study First Submitted: 2022-01-21
• Study First Submitted QC: 2022-02-10
• Study First Posted: 2022-02-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-21
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sufen with high DEX	high dose of dexmedetomidine with sufentanil	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
Sufen with low DEX	low dose of dexmedetomidine with sufentanil	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

Primary Outcome Measures

Name	Time	Method
Postoperative opioid analgesic dosage	48 hours postoperatively	the total opioid consumption in PCIA postoperatively

Secondary Outcome Measures

Name	Time	Method
Total pressing times of PCIA	48 hours postoperatively	extract the data from the electric analgesic pump
Remedial analgesics dosage	48 hours postoperatively	extract the data from the followup
LOS	through study completion, an average of 7 days postoperatively.	the length of stay
Patient satisfaction	48 hours postoperatively	patients' and relatives' satisfaction, 0 score refers to dissatisfaction, 10 score refers to satisfaction. Higher scores mean a better outcome.
Vomiting	72 hours postoperatively	the times of vomiting
Intraoperative opioid analgesic dosage	Intraoperative	Intraoperative opioid analgesic dosage
Effective pressing times of PCIA	48 hours postoperatively	extract the data from the electric analgesic pump
Sedation	72 hours postoperatively	Using RSAS(Riker Sedation Agitation Scale) to evaluate the status of sedation. 1 score is not aroused, 2 score is very calm, 3 score is calm, 4 score is quiet cooperation, 5 is mildly agitated, 6 score was moderate agitation, and 7 score was severe agitation. Higher and lower scores both mean a worse outcome.
Nausea	72 hours postoperatively	Using VRS (Verbal Rating Scales) to evaluate the degree of nausea. 0 score refers to comfort, 10 score refers to excruciating nause. Higher scores mean a worse outcome.
postoperative pain	48 hours postoperatively	using VAS method to evaluate pain status. 0 score refers to comfort, 10 score refers to excruciating pain. Higher scores mean a worse outcome.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China