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

NCT06882980 | Recruiting DMC

• 1 other identifier: MCHH_008
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adenotonsillectomy; Propofol; Ciprofol

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Mean arterial pressure (MAP)

  intraoperative period,3 minutes-1 hour

• Heart rate (HR)

  intraoperative period,3 minutes-1 hour

• Recovery time

  Postoperative 1 minutes to 1.5hours

• Dosage of anesthetic

  Intraoperative period, 20 minutes - 1.5 hours

• anesthetist satisfaction

  Postoperative 30 minutes

Study Arms (2)

Ciprofol group

EXPERIMENTAL

Ciprofol group patients will be given ciprofol during anesthesia induction and maintenance

Other: Ciprofol group

Propofol group

ACTIVE COMPARATOR

Propofol group patients will be given propofol during anesthesia induction and maintenance

Other: Propofol group

Interventions

Ciprofol group OTHER

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.

Ciprofol group

Propofol group OTHER

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.

Propofol group

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ASA I/II, age 3-11 years, weight 13-50 kg.
• Endoscopic T\&A or adenoidectomy.

You may not qualify if:

• Recent upper respiratory infection.
• Difficult airway, organ dysfunction, developmental/psychiatric disorders.
• Drug allergies.

Sponsors & Collaborators

• Maternal and Child Health Hospital of Hubei Province: lead

Study Sites (1)

Maternal and Child Health Hospital of Hubei Province

Wuhan, Hubei, 430000, China

RECRUITING

Study Officials

• Na Li, MD

  Maternal and Child Health Hospital of Hubei Province

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Na Li, MD

CONTACT

Telephone: Telephone:+86276349; Email:lina@hbfy.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician Investigator Affiliation Maternal and Child Health Hospital of Hubei Province

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 19, 2025
• Study Start: February 22, 2025
• Primary Completion: October 22, 2025
• Study Completion: November 22, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)