RemifentanilNCT07092384

Effect of Remifentanil on Pruritus and Paresthesia of Fospropofol Disodium Anesthesia

A study testing Remifentanil and Sufentanil in people with Remifentanil and Adverse Effects, run by Tongji Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Explore the effect of remifentanil on pruritus and paresthesia induced by fospropofol disodium in adults Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Remifentanil, Adverse Effects
What is being tested?: Remifentanil and Sufentanil
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 265 participants
Where: 1 siteChina
Study dates: 30 Jul 2025to 1 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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18-80 years old, plans to undergo elective non-cardiac surgery under general anesthesia.
ASA I-II;
The operation duration > 30 min;
BMI 18-30kg /m2；
Sign the informed consent form.

Who cannot join

history of drug abuse or alcohol dependence;
used sedative or analgesic drugs before operation;
with severe liver and kidney function impairment;
allergic to propofol and lipids;
surgery that directly affect hemodynamics with surgical operations, such as macrovascular surgery;
abnormal coagulation function, endocrine diseases or other effects on hemodynamic status;
Participation in other clinical researchers in the past 3 months

Trial locations and contacts

1 site in 1 country.

China1 site

Tongji Hospital
Wuhan, Hubei, 430030

Other trials in China

About this study

Official title: Effect of Remifentanil on Pruritus and Paresthesia Caused by Fospropofol Disodium Anesthesia

Explore the effect of remifentanil on pruritus and paresthesia induced by fospropofol disodium in adults

Read the detailed description

Explore the effect of remifentanil on pruritus and paresthesia caused by fospropofol disodium in adults, to observe the manifestations and duration of pruritus and paresthesia

Conditions: Remifentanil, Adverse Effects
Being tested: Remifentanil, Sufentanil

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RemifentanilDrug
Also called remi
Observe the incidence of pruritus and paresthesia after different doses of remifentanil and fospropofol disodium
SufentanilDrug
Also called sufen
Observe the incidence of pruritus and paresthesia after sufentanil and fospropofol disodium

Study groups in NCT07092384
Study group	Role	What they receive
Group R1	Experimental	remifentanil 0.5μg/kg Receives: Drug: Remifentanil
Group R2	Experimental	remifentanil 1.0μg/kg Receives: Drug: Remifentanil
Group R3	Experimental	remifentanil 1.5μg/kg Receives: Drug: Remifentanil
Group R4	Experimental	remifentanil 2.0μg/kg Receives: Drug: Remifentanil
Group S	Active comparator	sufentanil 0.3μg/kg Receives: Drug: Sufentanil

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of pruritus and paresthesia after administration of fospropofol disodium
Observe the incidence of pruritus and paresthesia in patients within 3 minutes after administration
Measured: 24 hours

Secondary outcomes (5)

Time of pruritus or paresthesia
time of pruritus and paresthesia occur after administration and 24h after surgery
Measured: 1 day
dosage of drugs
Doses of drugs used during induction and maintenance of anesthesia
Measured: 1 day
time records checklist
anesthesia time, induction time, surgical time, awakening time, and recovery time
Measured: 1 day
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Incidence of Treatment-Emergent Adverse Events
Measured: 1 day
duration of pruritus or paresthesia
pruritus and paresthesia occur after administration and 24h after surgery
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 20251 Dec 2025

First posted29 Jul 2025
Study start30 Jul 2025
Primary completion30 Nov 2025
Study completion1 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for RemifentanilStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 265 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07092384
Sponsor's protocol ID: ERPF
Status last verified: Dec 2025
First submitted: 15 Jul 2025
Last updated: 29 Dec 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
COMparative Performance of General Purpose Models
Neurosurgical Patients
RecruitingPhase 4
Remifentanil Versus Remifentanil-Lidocaine for Tracheal Extubation After Thyroidectomy
Tracheal Extubation, Cough
Recruiting
The Effects of Midazolam, Dexmedetomidine, and Esketamine on Bispectral Index and Raw Electroencephalogram in Patients Under Propofol-Remifentanil Baseline Anesthesia
Depth of Anesthesia Monitoring, BIS-EEG
Recruiting
The Impact of a Dexmedetomidine Perfusion on Intraoperative Remifentanil Consumption
Dexmedetomidine, Total Intravenous Anesthesia
RecruitingObservational study
Post Operative Cognitive Dysfunction After Oncologic Surgery
Emergence Delirium, Post-Operative Cognitive Dysfunction

All Remifentanil trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Remifentanil on Pruritus and Paresthesia Caused by Fospropofol Disodium Anesthesia
ClinicalTrials.gov ID: NCT07092384
Acronym / sponsor ID: ERPF
Conditions: Remifentanil, Adverse Effects
Study type: Interventional
Recruitment status: Completed
Enrolment: 265 participants (actual)
Lead sponsor: Tongji HospitalUniversity, hospital or other
Study start: 30 Jul 2025 (actual)
Primary completion: 30 Nov 2025 (actual)
Study completion: 1 Dec 2025 (actual)
First posted: 29 Jul 2025 (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.

Explore the effect of remifentanil on pruritus and paresthesia induced by fospropofol disodium in adults

Detailed description

Explore the effect of remifentanil on pruritus and paresthesia caused by fospropofol disodium in adults, to observe the manifestations and duration of pruritus and paresthesia

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Group R1	Experimental	Drug: Remifentanilremifentanil 0.5μg/kg
Group R2	Experimental	Drug: Remifentanilremifentanil 1.0μg/kg
Group R3	Experimental	Drug: Remifentanilremifentanil 1.5μg/kg
Group R4	Experimental	Drug: Remifentanilremifentanil 2.0μg/kg
Group S	Active comparator	Drug: Sufentanilsufentanil 0.3μg/kg

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age 18-80 years old, plans to undergo elective non-cardiac surgery under general anesthesia.
ASA I-II;
The operation duration > 30 min;
BMI 18-30kg /m2；
Sign the informed consent form.

Key exclusion criteria (7 listed)

history of drug abuse or alcohol dependence;
used sedative or analgesic drugs before operation;
with severe liver and kidney function impairment;
allergic to propofol and lipids;
surgery that directly affect hemodynamics with surgical operations, such as macrovascular surgery;

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
RemifentanilAlso: remiObserve the incidence of pruritus and paresthesia after different doses of remifentanil and fospropofol disodium	Drug	Group R1, Group R2, Group R3, Group R4
SufentanilAlso: sufenObserve the incidence of pruritus and paresthesia after sufentanil and fospropofol disodium	Drug	Group S

Primary outcome

Incidence of pruritus and paresthesia after administration of fospropofol disodium
Time frame: 24 hours
Observe the incidence of pruritus and paresthesia in patients within 3 minutes after administration

5 secondary outcomes

Time of pruritus or paresthesia
Time frame: 1 day
dosage of drugs
Time frame: 1 day
time records checklist
Time frame: 1 day
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1 day
duration of pruritus or paresthesia
Time frame: 24 hours

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 29 Dec 2025.
Individual participant dataSharing planned: No

Related trials for Remifentanil

RecruitingObservational study
COMparative Performance of General Purpose Models
Neurosurgical Patients
RecruitingPhase 4
Remifentanil Versus Remifentanil-Lidocaine for Tracheal Extubation After Thyroidectomy
Tracheal Extubation, Cough
Recruiting
The Effects of Midazolam, Dexmedetomidine, and Esketamine on Bispectral Index and Raw Electroencephalogram in Patients Under Propofol-Remifentanil Baseline Anesthesia
Depth of Anesthesia Monitoring, BIS-EEG
Recruiting
The Impact of a Dexmedetomidine Perfusion on Intraoperative Remifentanil Consumption
Dexmedetomidine, Total Intravenous Anesthesia
RecruitingObservational study
Post Operative Cognitive Dysfunction After Oncologic Surgery
Emergence Delirium, Post-Operative Cognitive Dysfunction

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.

aihua Du, Dr. study chair

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 Remifentanil and Sufentanil in people with Remifentanil and Adverse Effects, 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 7 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 29 Dec 2025. 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?

Incidence of pruritus and paresthesia after administration of fospropofol disodium (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07092384.

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 29 Dec 2025.