Ciprofol Based on Total Intravenous Anesthesia During Pediatric Laparoscopic Surgery

Ciprofol Based on Total Intravenous Anesthesia During Pediatric Laparoscopic Surgery: a Prospective, Double-blind, Randomized Controlled, Non Inferiority Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Laparoscopic Surgery; Appendicitis, Surgery; Pediatric Hernia
• Intervention / Treatment: Drug: Ciprofol; Drug: Propofol

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ciprofol; Ciprofol for anesthesia induction (0.5mg / kg) and anesthesia maintenance (1-2.5mg/ (kg·h))	Drug: Ciprofol; Ciprofol for anesthesia induction (0.5mg / kg) and anesthesia maintenance (1-2.5mg/ (kg·h))
Other: Propofol; Propofol for anesthesia induction (2mg / kg) and maintenance of anesthesia (4-10 mg / (kg·h))	Drug: Propofol; Propofol for anesthesia induction (2mg / kg) and maintenance of anesthesia (4-10 mg / (kg·h))

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extubation time	Time interval between drug withdrawal and removal of the tracheal catheter	up to 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aldrete Score	In the PACU, Investigators using Aldrete score scale(0- 10 points)	up to 2 hours
Emergence Agitation	In the PACU, Investigators assessed emergence delirium using PAED 0-20 points)	up to 2 hours
Postoperative Pain	use the FLACC pain score(0- 10 points)	24 hours
Postoperative nausea and vomiting	Investigators assessed postoperative nausea and vomiting BARF scale(0-10points)	24 hours
satisfaction degree	Child and/or Parent Satisfaction Survey (0-10 points)	24 hours

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Study Director: mujun Chang, Dr., Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2025
• Primary Completion (Actual): August 31, 2025
• Study Completion (Actual): August 31, 2025

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 25, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Children; Propofol; Ciprofol; Total Intravenous Anesthesia
• Additional Relevant MeSH Terms: Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Cecal Diseases; Intraabdominal Infections; Appendicitis; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Propofol; (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol
• Other Study ID Numbers: Tongji Hospital-20241204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No