SufentanilSFTANCT04067648
Sufentanil on Anesthesia Introduction and Recovery Quality in Pediatric Adenotonsillectomy
A study testing Sufentanil Injection in people with Sufentanil, run by Tongji Hospital at 1 site in China.
Trial summary
To study the effect of different doses of sufentanil on anesthesia induction and analgesia after tonsillectomy in children. According to the different doses of sufentanil used in anesthesia induction, the children were divided into 3groups. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Sufentanil
- What is being tested?
- Sufentanil Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2020to 18 Dec 2022
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 1-12 years,
- ASA I-II grade;
- selective adenotonsillectomy
- BMI 18.5～23.9,
- Sign informed consent
Who cannot join
- Emergency surgery;
- Abnormal liver and kidney function
- severe dehydration and malnutrition or Hb < 10g/dl;
- BMI <18.5 or <23.9;
- Children with neurological disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Three Doses of Sufentanil on Anesthesia Introduction and Recovery Quality in Pediatric Adenotonsillectomy
To study the effect of different doses of sufentanil on anesthesia induction and analgesia after tonsillectomy in children. According to the different doses of sufentanil used in anesthesia induction, the children were divided into 3groups. The vital signs during anesthesia, the recovery period of anesthesia and the complications after anesthesia were compared among the groups. The anesthetic effects and safety of sufentanil at different doses were discussed, which provided theoretical basis for clinical selection of the best drug dosage.
Read the detailed description
Fifteen minutes before operation, midazolam 0.1 mg/kg was slowly intravenously injected. Five minutes later, the child entered the operating room. Pi, Narcotrend, blood pressure, ECG, SpO2 and body temperature were monitored. Penehyclidine hydrochloride 0.01 mg/kg, dexamethasone 0.1 mg/kg, propofol 3 mg/kg, sufentanil (0.3μg/kg, 0.4 μg/kg, 0.5 μg/kg) were given during anesthesia induction. cis-atracurium 0.15 mg/kg, using the required type of tube for tracheal intubation. Sevoflurane 1.0 MAC + remifentanil 0.15 ug/kg/min 50% oxygen was given during anesthesia maintenance. Effective analgesia was achieved by adjusting the dosage of remifentanil during operation.
The changes of vital signs including perfusion index, Narcotrend, Bp, HR, oxygen saturation were observed before anesthesia induction, immediately after tracheal intubation, during tonsillectomy and adenoidectomy during operation, after extubation and in the recovery room. Then record the recovery time, restlessness and pain score during recovery period, postoperative pain, nausea and vomiting and other complications.
- Conditions
- Sufentanil
- Being tested
- Sufentanil Injection
- Keywords
- Sufentanil, perfusion index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sufentanil InjectionDrug
Also called adenotonsillectomy
three doses of sufentanil was intravenously given during anesthesia induction
| Study group | Role | What they receive |
|---|---|---|
| S1 group | Experimental | Sufentanil 0.3 μg/kg was intravenously given during anesthesia induction Receives: Drug: Sufentanil Injection |
| S2 group | Experimental | Sufentanil 0.4 μg/kg was intravenously given during anesthesia induction Receives: Drug: Sufentanil Injection |
| S3 group | Experimental | Sufentanil 0.5 μg/kg was intravenously given during anesthesia induction Receives: Drug: Sufentanil Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
adequate sufentanil dose
Adequate sufentanil dose is determined by Optimal intubation conditions and No hypotension or other severe side effects
Measured: 24 hours
Secondary outcomes (3)
cut off value of Pi for valid stress assessment
a validated and useful stress assessment for children during endotracheal intubation.
Measured: 24 hours
Narcotrend index
explore dose and age-related hemodynamic effects of sufentanil. Next to blood pressure and heart rate and continuous Narcotrend will be monitored. Then record the correlation between perfusion index and Narcotrend
Measured: 24 hours
postoperative complications with different doses of sufentanil
Including postoperative pain and the dosage of analgesics after operation and the satisfaction of children and parents
Measured: 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start6 Jul 2020
- Primary completion18 Dec 2022
- Study completion18 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SufentanilStudies of the same condition, open and under way.
- More trials run by Tongji 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aijun xu, Tongji Hospital
- Investigators
- Aijun XU, Dr., Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067648
- Sponsor's protocol ID
- SFTA
- Acronym
- SFTA
- Status last verified
- Jan 2023
- First submitted
- 17 Aug 2019
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the results of the experiment and the opinions of the children's families, it is decided whether to publish the data or not.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Three Doses of Sufentanil on Anesthesia Introduction and Recovery Quality in Pediatric Adenotonsillectomy
- ClinicalTrials.gov ID
- NCT04067648
- Acronym / sponsor ID
- SFTA / SFTA
- Conditions
- Sufentanil
- Keywords
- Sufentanil, perfusion index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 18 Dec 2022 (actual)
- Study completion
- 18 Dec 2022 (actual)
- First posted
- 26 Aug 2019 (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.
To study the effect of different doses of sufentanil on anesthesia induction and analgesia after tonsillectomy in children. According to the different doses of sufentanil used in anesthesia induction, the children were divided into 3groups. The vital signs during anesthesia, the recovery period of anesthesia and the complications after anesthesia were compared among the groups. The anesthetic effects and safety of sufentanil at different doses were discussed, which provided theoretical basis for clinical selection of the best drug dosage.
Detailed description
Fifteen minutes before operation, midazolam 0.1 mg/kg was slowly intravenously injected. Five minutes later, the child entered the operating room. Pi, Narcotrend, blood pressure, ECG, SpO2 and body temperature were monitored. Penehyclidine hydrochloride 0.01 mg/kg, dexamethasone 0.1 mg/kg, propofol 3 mg/kg, sufentanil (0.3μg/kg, 0.4 μg/kg, 0.5 μg/kg) were given during anesthesia induction. cis-atracurium 0.15 mg/kg, using the required type of tube for tracheal intubation. Sevoflurane 1.0 MAC + remifentanil 0.15 ug/kg/min 50% oxygen was given during anesthesia maintenance. Effective analgesia was achieved by adjusting the dosage of remifentanil during operation.
The changes of vital signs including perfusion index, Narcotrend, Bp, HR, oxygen saturation were observed before anesthesia induction, immediately after tracheal intubation, during tonsillectomy and adenoidectomy during operation, after extubation and in the recovery room. Then record the recovery time, restlessness and pain score during recovery period, postoperative pain, nausea and vomiting and other complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| S1 group | Experimental | Drug: Sufentanil InjectionSufentanil 0.3 μg/kg was intravenously given during anesthesia induction |
| S2 group | Experimental | Drug: Sufentanil InjectionSufentanil 0.4 μg/kg was intravenously given during anesthesia induction |
| S3 group | Experimental | Drug: Sufentanil InjectionSufentanil 0.5 μg/kg was intravenously given during anesthesia induction |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 1-12 years,
- ASA I-II grade;
- selective adenotonsillectomy
- BMI 18.5～23.9,
- Sign informed consent
Key exclusion criteria (5 listed)
- Emergency surgery;
- Abnormal liver and kidney function
- severe dehydration and malnutrition or Hb < 10g/dl;
- BMI <18.5 or <23.9;
- Children with neurological disorders
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 |
|---|---|---|
| Sufentanil InjectionAlso: adenotonsillectomythree doses of sufentanil was intravenously given during anesthesia induction | Drug | S1 group, S2 group, S3 group |
Primary outcome
adequate sufentanil dose
Time frame: 24 hours
Adequate sufentanil dose is determined by Optimal intubation conditions and No hypotension or other severe side effects
3 secondary outcomes
cut off value of Pi for valid stress assessment
Time frame: 24 hours
Narcotrend index
Time frame: 24 hours
postoperative complications with different doses of sufentanil
Time frame: 7days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Individual participant dataSharing planned: No. According to the results of the experiment and the opinions of the children's families, it is decided whether to publish the data or not.
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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.
Aijun XU, Dr. principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sufentanil Injection in people with Sufentanil, run by Tongji 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 10 Jan 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
adequate sufentanil dose (time frame: 24 hours). 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 10 Jan 2023.