AdenotonsillectomyNCT06882980
Comparison of Ciprofol and Propofol Under IoC1 and IoC2 Monitoring for Adenotonsillectomy
A study testing Ciprofol group and Propofol group in people with Adenotonsillectomy and Propofol, run by Maternal and Child Health Hospital of Hubei Province at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Adenotonsillectomy, Propofol, Ciprofol
- What is being tested?
- Ciprofol group and Propofol group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteChina
- Study dates
- 22 Feb 2025to 22 Nov 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ASA I/II, age 3-11 years, weight 13-50 kg.
- Endoscopic T\&A or adenoidectomy.
Who cannot join
- Recent upper respiratory infection.
- Difficult airway, organ dysfunction, developmental/psychiatric disorders.
- Drug allergies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Maternal and Child Health Hospital of Hubei Province
Wuhan, Hubei, 430000
Na Li,, +862763490107, lina@hbfy.com
About this study
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
- Being tested
- Ciprofol group, Propofol group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprofol groupOther
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Ciprofol group | Experimental | Ciprofol group patients will be given ciprofol during anesthesia induction and maintenance Receives: Other: Ciprofol group |
| Propofol group | Active comparator | Propofol group patients will be given propofol during anesthesia induction and maintenance Receives: Other: Propofol group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: 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)
Measured: intraoperative period,10 minutes-1 hours
Secondary outcomes (7)
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)
Measured: 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)
Measured: 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.
Measured: Postoperative 1 minutes to 1.5hours
Dosage of anesthetic
The total amount of sedative and analgesic drugs will be recorded.
Measured: 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
Measured: 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
Measured: 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.
Measured: Postoperative 1 minute-1hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start22 Feb 2025
- Primary completion22 Oct 2025 (estimated)
- Study completion22 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenotonsillectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maternal and Child Health Hospital of Hubei Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Na, Maternal and Child Health Hospital of Hubei Province
- Investigators
- Na Li, MD, Principal investigator, Maternal and Child Health Hospital of Hubei Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882980
- Sponsor's protocol ID
- MCHH_008
- Status last verified
- Jun 2025
- First submitted
- 10 Mar 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes