Ciprofol Based on Total Intravenous Anesthesia During Pediatric Laparoscopic Surgery

Not Applicable

Recruiting

• Conditions: Pediatric Hernia; Laparoscopic Surgery; Appendicitis, Surgery
• Interventions: Drug: Ciprofol; Drug: Propofol

• Registration Number: NCT06735430
• Lead Sponsor: Tongji Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-11
• Study First Posted: 2024-12-16
• Study Start: 2025-03-09
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-11
• Primary Completion: 2026-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 86

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ciprofol	Ciprofol	Ciprofol for anesthesia induction (0.5mg / kg) and anesthesia maintenance (1-2.5mg/ (kg·h))
Propofol	Propofol	Propofol for anesthesia induction (2mg / kg) and maintenance of anesthesia (4-10 mg / (kg·h))

Primary Outcome Measures

Name	Time	Method
Extubation time	up to 1 hour	Time interval between drug withdrawal and removal of the tracheal catheter

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tongji hospital; 🇨🇳 Wuhan, Hubei, China