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Ciprofol Based on Total Intravenous Anesthesia During Pediatric Laparoscopic Surgery

NCT ID: NCT06735430

Last Updated: 2025-12-29

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-09

Study Completion Date

2025-08-31

Brief Summary

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a prospective, double-blind, fully randomized controlled, non-inferiority clinical trial to investigate the use of total intravenous anesthesia in pediatric laparoscopic surgery.

Detailed Description

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Ciprofol is a better alternative to surgical sedatives. The clinical application basis of Ciprofol in pediatric anesthesia is still lacking. Therefore, the investigators designed a prospective, double-blind, fully randomized controlled, non-inferiority clinical trial to investigate the use of all-through intravenous anesthesia in pediatric laparoscopic surgery. Our main hypothesis is that in pediatric surgery, using Ciprofol by intravenous anesthesia, the extubation time is no longer than that the propofol group.

Conditions

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Pediatric Hernia Laparoscopic Surgery Appendicitis, Surgery

Keywords

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Ciprofol Propofol Total Intravenous Anesthesia Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ciprofol

Ciprofol for anesthesia induction (0.5mg / kg) and anesthesia maintenance (1-2.5mg/ (kg·h))

Group Type EXPERIMENTAL

Ciprofol

Intervention Type DRUG

Ciprofol for anesthesia induction (0.5mg / kg) and anesthesia maintenance (1-2.5mg/ (kg·h))

Propofol

Propofol for anesthesia induction (2mg / kg) and maintenance of anesthesia (4-10 mg / (kg·h))

Group Type OTHER

Propofol

Intervention Type DRUG

Propofol for anesthesia induction (2mg / kg) and maintenance of anesthesia (4-10 mg / (kg·h))

Interventions

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Ciprofol

Ciprofol for anesthesia induction (0.5mg / kg) and anesthesia maintenance (1-2.5mg/ (kg·h))

Intervention Type DRUG

Propofol

Propofol for anesthesia induction (2mg / kg) and maintenance of anesthesia (4-10 mg / (kg·h))

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* laparoscopic surgery under general anesthesia

Exclusion Criteria

* Known allergies to propofol and ciprofol,
* Mental retardation, cognitive and affective disorders, psychiatric or neurological disorders;
* uncooperate with peripheral venipuncture and catheterization;
* History of acute upper respiratory tract infection in the past 2 weeks;
* With severe respiratory, circulation, liver and kidney insufficiency;
* Body mass index (BMI) of 30 kg/m² or 15 kg/m²;
* Known long-term use of sedative drugs;
* ASAⅢ grade or above;
* recent participation in other clinical studies.
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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aijun xu

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mujun Chang, Dr.

Role: STUDY_DIRECTOR

Tongji Hospital

Locations

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Tongji hospital

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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Tongji Hospital-20241204

Identifier Type: -

Identifier Source: org_study_id