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

Dexmedetomidine Clinical Trial

— DEX  

Official title:

The Effect of Combination of Dexmedetomidine and Sufentanil in Patient-controlled Intravenous Analgesia on Pediatric Patients Undergoing Scoliosis Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05249153
• Other study ID #: ZS-2546
• Status: Recruiting
• Phase: N/A
• Start date: September 23, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2022
• Source: Peking Union Medical College Hospital
• Contact: Bo Zhu, MD
• Phone: +861069152001
• Email: zhubo[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dexmedetomidine
• Scoliosis

Intervention

Drug:
• 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)
• 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)

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative opioid analgesic dosage	the total opioid consumption in PCIA postoperatively	48 hours postoperatively
Secondary	Intraoperative opioid analgesic dosage	Intraoperative opioid analgesic dosage	Intraoperative
Secondary	Effective pressing times of PCIA	extract the data from the electric analgesic pump	48 hours postoperatively
Secondary	Total pressing times of PCIA	extract the data from the electric analgesic pump	48 hours postoperatively
Secondary	Remedial analgesics dosage	extract the data from the followup	48 hours postoperatively
Secondary	postoperative pain	using VAS method to evaluate pain status. 0 score refers to comfort, 10 score refers to excruciating pain. Higher scores mean a worse outcome.	48 hours postoperatively
Secondary	LOS	the length of stay	through study completion, an average of 7 days postoperatively.
Secondary	Patient satisfaction	patients' and relatives' satisfaction, 0 score refers to dissatisfaction, 10 score refers to satisfaction. Higher scores mean a better outcome.	48 hours postoperatively
Secondary	Nausea	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.	4 hours postoperatively
Secondary	Nausea	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.	8 hours postoperatively
Secondary	Nausea	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.	24 hours postoperatively
Secondary	Nausea	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.	48 hours postoperatively
Secondary	Nausea	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.	72 hours postoperatively
Secondary	Sedation	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.	4 hours postoperatively
Secondary	Sedation	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.	8 hours postoperatively
Secondary	Sedation	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.	24 hours postoperatively
Secondary	Sedation	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.	48 hours postoperatively
Secondary	Sedation	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.	72 hours postoperatively
Secondary	Vomiting	the times of vomiting	4 hours postoperatively
Secondary	Vomiting	the times of vomiting	8 hours postoperatively
Secondary	Vomiting	the times of vomiting	24 hours postoperatively
Secondary	Vomiting	the times of vomiting	48 hours postoperatively
Secondary	Vomiting	the times of vomiting	72 hours postoperatively