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

November 18, 2024 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 10 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Sufen
PCIA: continue with 0.05ug/kg/h sufentanil, 0.05ug/kg sufentainil bolus
Experimental: 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
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)
Other Names:
  • Sufen with low DEX
Experimental: 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
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)
Other Names:
  • Sufen with high DEX

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative opioid analgesic dosage
Time Frame: 48 hours postoperatively
the total opioid consumption in PCIA postoperatively
48 hours postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intraoperative opioid analgesic dosage
Time Frame: Intraoperative
Intraoperative opioid analgesic dosage
Intraoperative
Effective pressing times of PCIA
Time Frame: 48 hours postoperatively
extract the data from the electric analgesic pump
48 hours postoperatively
Total pressing times of PCIA
Time Frame: 48 hours postoperatively
extract the data from the electric analgesic pump
48 hours postoperatively
Remedial analgesics dosage
Time Frame: 48 hours postoperatively
extract the data from the followup
48 hours postoperatively
postoperative pain
Time Frame: 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.
48 hours postoperatively
LOS
Time Frame: through study completion, an average of 7 days postoperatively.
the length of stay
through study completion, an average of 7 days postoperatively.
Patient satisfaction
Time Frame: 48 hours postoperatively
patients' and relatives' satisfaction, 0 score refers to dissatisfaction, 10 score refers to satisfaction. Higher scores mean a better outcome.
48 hours postoperatively
Nausea
Time Frame: 4 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.
4 hours postoperatively
Nausea
Time Frame: 8 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.
8 hours postoperatively
Nausea
Time Frame: 24 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.
24 hours postoperatively
Nausea
Time Frame: 48 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.
48 hours postoperatively
Nausea
Time Frame: 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.
72 hours postoperatively
Sedation
Time Frame: 4 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.
4 hours postoperatively
Sedation
Time Frame: 8 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.
8 hours postoperatively
Sedation
Time Frame: 24 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.
24 hours postoperatively
Sedation
Time Frame: 48 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.
48 hours postoperatively
Sedation
Time Frame: 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.
72 hours postoperatively
Vomiting
Time Frame: 4 hours postoperatively
the times of vomiting
4 hours postoperatively
Vomiting
Time Frame: 8 hours postoperatively
the times of vomiting
8 hours postoperatively
Vomiting
Time Frame: 24 hours postoperatively
the times of vomiting
24 hours postoperatively
Vomiting
Time Frame: 48 hours postoperatively
the times of vomiting
48 hours postoperatively
Vomiting
Time Frame: 72 hours postoperatively
the times of vomiting
72 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yuguang Huang, MD, Anesthesiology of PUMCH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 23, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZS-2546

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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