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

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.

Study Overview

• Status: Recruiting
• Conditions: Adenotonsillectomy; Propofol; Ciprofol
• Intervention / Treatment: Other: Ciprofol group; Other: Propofol group

• Study Type: Interventional
• Enrollment (Estimated): 236
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Na Li, MD; Phone Number: Telephone: Telephone:+86276349; Email: Email:lina@hbfy.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Maternal and Child Health Hospital of Hubei Province
      • Contact: Na Li,; Phone Number: +862763490107; Email: lina@hbfy.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ciprofol group; Ciprofol group patients will be given ciprofol during anesthesia induction and maintenance	Other: 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.
Active Comparator: Propofol group; Propofol group patients will be given propofol during anesthesia induction and maintenance	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction Compliance checklist(ICC)	Induction Compliance checklist(ICC) will be recorded during the time of anesthesia induction.defined as a score out of 10.A score of 0 indicates perfect cooperation	during the time of anesthesia induction ,1 minute-10 minutes
The time to loss of consciousness during anesthesia induction	The time to loss of consciousness during anesthesia induction will be recorded after the injection of anesthetic	after the injection of anesthetic ,1second-5miutes
sedation/consciousness (IoC1)	sedation/consciousness (IoC1) will be recorded at 2 time points,including the time of intubation(T2) and mouth gag placement(T3)	intraoperative period,10 minutes-1 hours
analgesia/pain-stress (IoC2)	analgesia/pain-stress (IoC2) will be recorded at 2 time points,including the time of intubation(T2) and mouth gag placement(T3)	intraoperative period,10 minutes-1 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean arterial pressure (MAP)	MAP will be monitored and recorded at 4 time points, including T1 (baseline), T2 (intubation), T3 (mouth gag placement), T4 (extubation)	intraoperative period,3 minutes-1 hour
Heart rate (HR)	HR will be monitored and recorded at 4 time points, including T1 (baseline), T2 (intubation), T3 (mouth gag placement), T4 (extubation)	intraoperative period,3 minutes-1 hour
Recovery time	Time to fully awake. defined as by a modified Aldrete score which will be recorded with a recovery index of 9 to 26. The higher score means more awake.	Postoperative 1 minutes to 1.5hours
Dosage of anesthetic	The total amount of sedative and analgesic drugs will be recorded.	Intraoperative period, 20 minutes - 1.5 hours
anesthetist satisfaction	Record the satisfaction of the anesthetist with the Ciprofol or Propofol ,defined as a score out of100.The higher score means more satisfaction	Postoperative 30 minutes
Adverse events	The adverse events will be monitored and recorded during the operation and post-operation. AE will include:hypotension, bradycardia, respiratory depression, airway spasm, nausea, and vomiting	the procedure and Postoperative 24 hours
Pediatric Anesthesia Emergence Delirium (PAED) Scale	The Pediatric Anesthesia Emergence Delirium (PAED) Scale is a behavioral observation tool used to assess whether emergence delirium occurs in children after anesthesia. The total score ranges from 0 to 20.and a score of 10 or above is diagnostic of emergence delirium.A higher score indicates a greater tendency toward emergence delirium.	Postoperative 1 minute-1hour

Collaborators and Investigators

• Sponsor: Maternal and Child Health Hospital of Hubei Province
• Investigators: Principal Investigator: Na Li, MD, Maternal and Child Health Hospital of Hubei Province

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2025
• Primary Completion (Estimated): October 22, 2025
• Study Completion (Estimated): November 22, 2025

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 15, 2025
• First Posted (Actual): March 19, 2025

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Propofol
• Other Study ID Numbers: MCHH_008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No