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NCT Number: NCT06882980

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.

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Key information

Conditions

Adenotonsillectomy Ciprofol Propofol

Age range

3 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maternal and Child Health Hospital of Hubei Province

Wuhan, Hubei, 430000, China

Location status: Recruiting

Location contact

Na Li,

CONTACT

[email protected]

+862763490107

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Induction Compliance checklist(ICC)

    Time frame: during the time of anesthesia induction ,1 minute-10 minutes

    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

  2. The time to loss of consciousness during anesthesia induction

    Time frame: after the injection of anesthetic ,1second-5miutes

    The time to loss of consciousness during anesthesia induction will be recorded after the injection of anesthetic

  3. sedation/consciousness (IoC1)

    Time frame: intraoperative period,10 minutes-1 hours

    sedation/consciousness (IoC1) will be recorded at 2 time points,including the time of intubation(T2) and mouth gag placement(T3)

  4. analgesia/pain-stress (IoC2)

    Time frame: intraoperative period,10 minutes-1 hours

    analgesia/pain-stress (IoC2) will be recorded at 2 time points,including the time of intubation(T2) and mouth gag placement(T3)

Secondary outcomes

  1. Mean arterial pressure (MAP)

    Time frame: intraoperative period,3 minutes-1 hour

    MAP will be monitored and recorded at 4 time points, including T1 (baseline), T2 (intubation), T3 (mouth gag placement), T4 (extubation)

  2. Heart rate (HR)

    Time frame: intraoperative period,3 minutes-1 hour

    HR will be monitored and recorded at 4 time points, including T1 (baseline), T2 (intubation), T3 (mouth gag placement), T4 (extubation)

  3. Recovery time

    Time frame: Postoperative 1 minutes to 1.5hours

    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.

  4. Dosage of anesthetic

    Time frame: Intraoperative period, 20 minutes - 1.5 hours

    The total amount of sedative and analgesic drugs will be recorded.

  5. anesthetist satisfaction

    Time frame: Postoperative 30 minutes

    Record the satisfaction of the anesthetist with the Ciprofol or Propofol ,defined as a score out of100.The higher score means more satisfaction

  6. Adverse events

    Time frame: the procedure and Postoperative 24 hours

    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

  7. Pediatric Anesthesia Emergence Delirium (PAED) Scale

    Time frame: Postoperative 1 minute-1hour

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Na Li, MD

CONTACT

Email:[email protected]

Telephone: Telephone:+86276349

Sponsors and collaborators

Lead sponsor

Maternal and Child Health Hospital of Hubei Province

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2025
Registry last updated
Jun 12, 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.

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