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

Primary Purpose

Dexmedetomidine

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
low dose of dexmedetomidine with sufentanil
high dose of dexmedetomidine with sufentanil
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dexmedetomidine focused on measuring dexmedetomidine, pediatric anesthesia, patient-control analgesia, scoliosis orthopedics

Eligibility Criteria

1 Year - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Sufen

Sufen with low DEX

Sufen with high DEX

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Postoperative opioid analgesic dosage
the total opioid consumption in PCIA postoperatively

Secondary Outcome Measures

Intraoperative opioid analgesic dosage
Intraoperative opioid analgesic dosage
Effective pressing times of PCIA
extract the data from the electric analgesic pump
Total pressing times of PCIA
extract the data from the electric analgesic pump
Remedial analgesics dosage
extract the data from the followup
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.
LOS
the length of stay
Patient satisfaction
patients' and relatives' satisfaction, 0 score refers to dissatisfaction, 10 score refers to satisfaction. Higher scores mean a better outcome.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Vomiting
the times of vomiting
Vomiting
the times of vomiting
Vomiting
the times of vomiting
Vomiting
the times of vomiting
Vomiting
the times of vomiting

Full Information

First Posted
January 21, 2022
Last Updated
February 10, 2022
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05249153
Brief Title
Dexmedetomidine and Sufentanil Effect in PCA on Pediatric Patients Undergoing Scoliosis Surgery
Acronym
DEX
Official Title
The Effect of Combination of Dexmedetomidine and Sufentanil in Patient-controlled Intravenous Analgesia on Pediatric Patients Undergoing Scoliosis Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 23, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dexmedetomidine
Keywords
dexmedetomidine, pediatric anesthesia, patient-control analgesia, scoliosis orthopedics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sufen
Arm Type
No Intervention
Arm Description
PCIA: continue with 0.05ug/kg/h sufentanil, 0.05ug/kg sufentainil bolus
Arm Title
Sufen with low DEX
Arm Type
Experimental
Arm Description
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
Arm Title
Sufen with high DEX
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
low dose of dexmedetomidine with sufentanil
Other Intervention Name(s)
Sufen with low DEX
Intervention Description
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
Intervention Name(s)
high dose of dexmedetomidine with sufentanil
Other Intervention Name(s)
Sufen with high DEX
Intervention Description
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)
Primary Outcome Measure Information:
Title
Postoperative opioid analgesic dosage
Description
the total opioid consumption in PCIA postoperatively
Time Frame
48 hours postoperatively
Secondary Outcome Measure Information:
Title
Intraoperative opioid analgesic dosage
Description
Intraoperative opioid analgesic dosage
Time Frame
Intraoperative
Title
Effective pressing times of PCIA
Description
extract the data from the electric analgesic pump
Time Frame
48 hours postoperatively
Title
Total pressing times of PCIA
Description
extract the data from the electric analgesic pump
Time Frame
48 hours postoperatively
Title
Remedial analgesics dosage
Description
extract the data from the followup
Time Frame
48 hours postoperatively
Title
postoperative pain
Description
using VAS method to evaluate pain status. 0 score refers to comfort, 10 score refers to excruciating pain. Higher scores mean a worse outcome.
Time Frame
48 hours postoperatively
Title
LOS
Description
the length of stay
Time Frame
through study completion, an average of 7 days postoperatively.
Title
Patient satisfaction
Description
patients' and relatives' satisfaction, 0 score refers to dissatisfaction, 10 score refers to satisfaction. Higher scores mean a better outcome.
Time Frame
48 hours postoperatively
Title
Nausea
Description
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.
Time Frame
4 hours postoperatively
Title
Nausea
Description
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.
Time Frame
8 hours postoperatively
Title
Nausea
Description
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.
Time Frame
24 hours postoperatively
Title
Nausea
Description
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.
Time Frame
48 hours postoperatively
Title
Nausea
Description
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.
Time Frame
72 hours postoperatively
Title
Sedation
Description
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.
Time Frame
4 hours postoperatively
Title
Sedation
Description
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.
Time Frame
8 hours postoperatively
Title
Sedation
Description
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.
Time Frame
24 hours postoperatively
Title
Sedation
Description
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.
Time Frame
48 hours postoperatively
Title
Sedation
Description
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.
Time Frame
72 hours postoperatively
Title
Vomiting
Description
the times of vomiting
Time Frame
4 hours postoperatively
Title
Vomiting
Description
the times of vomiting
Time Frame
8 hours postoperatively
Title
Vomiting
Description
the times of vomiting
Time Frame
24 hours postoperatively
Title
Vomiting
Description
the times of vomiting
Time Frame
48 hours postoperatively
Title
Vomiting
Description
the times of vomiting
Time Frame
72 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bo Zhu, MD
Phone
+861069152001
Email
zhubo@pumch.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuguang Huang, MD
Organizational Affiliation
Anesthesiology of PUMCH
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Zhu, M.D.
Phone
+861069152001
Email
zhubo@pumch.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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

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