Comparison of Ciprofol and Propofol Under IoC1 and IoC2 Monitoring for Adenotonsillectomy

NCT ID: NCT06882980

Last Updated: 2025-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-22

Study Completion Date

2025-11-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to compare the Ciprofol and Propofol Under IoC1 and IoC2 Monitoring for Adenotonsillectomy Participants will be randomly allocated to two groups: Ciprofol group (Group C) and Propofol group (Group P). For those in Group C: they will be given ciprofol during anesthesia induction and maintenance .For those in Group P: they will be pgiven ciprofol during anesthesia induction and maintenanc This study evaluates ciprofol versus propofol under IoC1/IoC2 guidance in pediatric T\&A, providing evidence for ciprofol's efficacy and safety in pediatric anesthesia.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adenotonsillectomy Propofol Ciprofol

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ciprofol group

Ciprofol group patients will be given ciprofol during anesthesia induction and maintenance

Group Type EXPERIMENTAL

Ciprofol group

Intervention Type OTHER

In the Ciprofol group,children were given Ciprofol 0.6-0.8 mg/kg during anesthesia induction,and ciprofol 1.2-2 mg·kg-¹·h-¹for anesthesia maintenance.Throughout the entire process, we continuously monitor vital signs and IoC1/IoC2.

Propofol group

Propofol group patients will be given propofol during anesthesia induction and maintenance

Group Type ACTIVE_COMPARATOR

Propofol group

Intervention Type OTHER

In the Propofol group,children were given Propofol 2.5-3.5 mg/kg during anesthesia induction,and propofol 6-10 mg·kg-¹·h-¹for anesthesia maintenance.Throughout the entire process, we continuously monitor vital signs and IoC1/IoC2.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ciprofol group

In the Ciprofol group,children were given Ciprofol 0.6-0.8 mg/kg during anesthesia induction,and ciprofol 1.2-2 mg·kg-¹·h-¹for anesthesia maintenance.Throughout the entire process, we continuously monitor vital signs and IoC1/IoC2.

Intervention Type OTHER

Propofol group

In the Propofol group,children were given Propofol 2.5-3.5 mg/kg during anesthesia induction,and propofol 6-10 mg·kg-¹·h-¹for anesthesia maintenance.Throughout the entire process, we continuously monitor vital signs and IoC1/IoC2.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ASA I/II, age 3-11 years, weight 13-50 kg.

Endoscopic T\&A or adenoidectomy.

Exclusion Criteria

* Recent upper respiratory infection.

Difficult airway, organ dysfunction, developmental/psychiatric disorders.

Drug allergies.
Minimum Eligible Age

3 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Maternal and Child Health Hospital of Hubei Province

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Li Na

Deputy chief physician Investigator Affiliation Maternal and Child Health Hospital of Hubei Province

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Na Li, MD

Role: PRINCIPAL_INVESTIGATOR

Maternal and Child Health Hospital of Hubei Province

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Maternal and Child Health Hospital of Hubei Province

Wuhan, Hubei, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Na Li, MD

Role: CONTACT

Telephone: Telephone:+86276349

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Na Li,

Role: primary

+862763490107

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MCHH_008

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.