Skip to main content
OpenTrials
Completed

NCT Number: NCT06735430

Ciprofol Based on Total Intravenous Anesthesia During Pediatric Laparoscopic Surgery

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pediatric Hernia Appendicitis Appendicitis, Surgery Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections Laparoscopic Surgery

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongji hospital

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ciprofol

Drug

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

Propofol

Drug

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

Primary outcomes

  1. Extubation time

    Time frame: up to 1 hour

    Time interval between drug withdrawal and removal of the tracheal catheter

Secondary outcomes

  1. Aldrete Score

    Time frame: up to 2 hours

    In the PACU, Investigators using Aldrete score scale(0- 10 points)

  2. Emergence Agitation

    Time frame: up to 2 hours

    In the PACU, Investigators assessed emergence delirium using PAED 0-20 points)

  3. Postoperative Pain

    Time frame: 24 hours

    use the FLACC pain score(0- 10 points)

  4. Postoperative nausea and vomiting

    Time frame: 24 hours

    Investigators assessed postoperative nausea and vomiting BARF scale(0-10points)

  5. satisfaction degree

    Time frame: 24 hours

    Child and/or Parent Satisfaction Survey (0-10 points)

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 16, 2024
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.