BridgeMD
New treatment option for Pediatric
Official title The ED95 of Ciprofol for Laryngeal Mask Airway Insertion With Fentanyl in Children: A Biased-Coin Dose-Finding Trial
ClinicalTrials.gov ID: NCT07697404
What this study is testing
What is Ciprofol?
Ciprofol is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pediatric.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Ciprofol is a novel intravenous anesthetic with a pharmacological profile similar to propofol but with a lower incidence of injection pain, hypotension, and respiratory depression. For pediatric day-case surgeries, laryngeal mask airway (LMA) insertion without neuromuscular blockers is increasingly preferred.
- Phase 4: studies an already-approved treatment
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 12
You may be able to join if
- American Society of Anesthesiologists (ASA) physical status I or II
- Aged 1 to 12 years
- Scheduled for elective surgery requiring general anesthesia with laryngeal mask airway (LMA) insertion (e.g., ophthalmic surgery, skin lesion...
- Written informed consent obtained from parents or legal guardians
You likely can't join if
- Known allergy or hypersensitivity to ciprofol, fentanyl, or any study-related drugs
- Intellectual disability, cognitive-affective disorders, psychiatric or neurological diseases
- Inability to cooperate with peripheral intravenous cannulation
- History of reactive airway disease or suspected difficult airway
- Body mass index (BMI) ≥ 30 kg/m² or ≤ 15 kg/m²
- History of sedative medication use
See the full eligibility criteria
- American Society of Anesthesiologists (ASA) physical status I or II
- Aged 1 to 12 years
- Scheduled for elective surgery requiring general anesthesia with laryngeal mask airway (LMA) insertion (e.g., ophthalmic surgery, skin lesion excision, minor abdominal or urological procedures, with expected surgical...
- Written informed consent obtained from parents or legal guardians
- Known allergy or hypersensitivity to ciprofol, fentanyl, or any study-related drugs
- Intellectual disability, cognitive-affective disorders, psychiatric or neurological diseases
- Inability to cooperate with peripheral intravenous cannulation
- History of reactive airway disease or suspected difficult airway
- Body mass index (BMI) ≥ 30 kg/m² or ≤ 15 kg/m²
- History of sedative medication use
- Inability to understand the study protocol or participation in another clinical trial within the past 30 days
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.