DexmedetomidineDEXNCT05249153
Dexmedetomidine and Sufentanil Effect in PCA on Pediatric Patients Undergoing Scoliosis Surgery
A study testing low dose of dexmedetomidine with sufentanil and high dose of dexmedetomidine with sufentanil in people with Dexmedetomidine, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Dexmedetomidine
- What is being tested?
- low dose of dexmedetomidine with sufentanil and high dose of dexmedetomidine with sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2020to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Allergy to dexmedetomidine;
- Obvious abnormalities of heart, lung, liver, renal function and endocrine function;
- Patients who can not cooperate with this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: 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.
Read the 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.
- Conditions
- Dexmedetomidine
- Being tested
- low dose of dexmedetomidine with sufentanil, high dose of dexmedetomidine with sufentanil
- Keywords
- dexmedetomidine, pediatric anesthesia, patient-control analgesia, scoliosis orthopedics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low dose of dexmedetomidine with sufentanilDrug
Also called Sufen with low DEX
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 sufentanilDrug
Also called Sufen with high DEX
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: high dose of dexmedetomidine with sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid analgesic dosage
the total opioid consumption in PCIA postoperatively
Measured: 48 hours postoperatively
Secondary outcomes (22)
Intraoperative opioid analgesic dosage
Intraoperative opioid analgesic dosage
Measured: Intraoperative
Effective pressing times of PCIA
extract the data from the electric analgesic pump
Measured: 48 hours postoperatively
Total pressing times of PCIA
extract the data from the electric analgesic pump
Measured: 48 hours postoperatively
Remedial analgesics dosage
extract the data from the followup
Measured: 48 hours postoperatively
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.
Measured: 48 hours postoperatively
LOS
the length of stay
Measured: through study completion, an average of 7 days postoperatively.
Patient satisfaction
patients' and relatives' satisfaction, 0 score refers to dissatisfaction, 10 score refers to satisfaction. Higher scores mean a better outcome.
Measured: 48 hours postoperatively
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.
Measured: 4 hours postoperatively
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.
Measured: 8 hours postoperatively
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.
Measured: 24 hours postoperatively
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.
Measured: 48 hours postoperatively
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.
Measured: 72 hours postoperatively
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.
Measured: 4 hours postoperatively
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.
Measured: 8 hours postoperatively
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.
Measured: 24 hours postoperatively
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.
Measured: 48 hours postoperatively
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.
Measured: 72 hours postoperatively
Vomiting
the times of vomiting
Measured: 4 hours postoperatively
Vomiting
the times of vomiting
Measured: 8 hours postoperatively
Vomiting
the times of vomiting
Measured: 24 hours postoperatively
Vomiting
the times of vomiting
Measured: 48 hours postoperatively
Vomiting
the times of vomiting
Measured: 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start23 Sep 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuguang Huang, MD, Study chair, Anesthesiology of PUMCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249153
- Sponsor's protocol ID
- ZS-2546
- Acronym
- DEX
- Status last verified
- Feb 2024
- First submitted
- 21 Jan 2022
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combination of Dexmedetomidine and Sufentanil in Patient-controlled Intravenous Analgesia on Pediatric Patients Undergoing Scoliosis Surgery
- ClinicalTrials.gov ID
- NCT05249153
- Acronym / sponsor ID
- DEX / ZS-2546
- Conditions
- Dexmedetomidine
- Keywords
- dexmedetomidine, pediatric anesthesia, patient-control analgesia, scoliosis orthopedics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sufen | No intervention | –PCIA: continue with 0.05ug/kg/h sufentanil, 0.05ug/kg sufentainil bolus |
| Sufen with low DEX | Experimental | Drug: low dose of dexmedetomidine with sufentanilPCIA: 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 |
| Sufen with high DEX | Experimental | Drug: high dose of dexmedetomidine with sufentanilPCIA: 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 |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Allergy to dexmedetomidine;
- Obvious abnormalities of heart, lung, liver, renal function and endocrine function;
- Patients who can not cooperate with this trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low dose of dexmedetomidine with sufentanilAlso: Sufen with low DEXlow 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) | Drug | Sufen with low DEX |
| high dose of dexmedetomidine with sufentanilAlso: Sufen with high DEXhigh 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) | Drug | Sufen with high DEX |
Primary outcome
Postoperative opioid analgesic dosage
Time frame: 48 hours postoperatively
the total opioid consumption in PCIA postoperatively
22 secondary outcomes
Intraoperative opioid analgesic dosage
Time frame: Intraoperative
Effective pressing times of PCIA
Time frame: 48 hours postoperatively
Total pressing times of PCIA
Time frame: 48 hours postoperatively
Remedial analgesics dosage
Time frame: 48 hours postoperatively
postoperative pain
Time frame: 48 hours postoperatively
LOS
Time frame: through study completion, an average of 7 days postoperatively.
Patient satisfaction
Time frame: 48 hours postoperatively
Nausea
Time frame: 4 hours postoperatively
Nausea
Time frame: 8 hours postoperatively
Nausea
Time frame: 24 hours postoperatively
Nausea
Time frame: 48 hours postoperatively
Nausea
Time frame: 72 hours postoperatively
Sedation
Time frame: 4 hours postoperatively
Sedation
Time frame: 8 hours postoperatively
Sedation
Time frame: 24 hours postoperatively
Sedation
Time frame: 48 hours postoperatively
Sedation
Time frame: 72 hours postoperatively
Vomiting
Time frame: 4 hours postoperatively
Vomiting
Time frame: 8 hours postoperatively
Vomiting
Time frame: 24 hours postoperatively
Vomiting
Time frame: 48 hours postoperatively
Vomiting
Time frame: 72 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuguang Huang, MD study chair
Anesthesiology of PUMCH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low dose of dexmedetomidine with sufentanil and high dose of dexmedetomidine with sufentanil in people with Dexmedetomidine, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative opioid analgesic dosage (time frame: 48 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.