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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ciprofol and Propofol Under IoC1 and IoC2 Monitoring for Adenotonsillectomy
- ClinicalTrials.gov ID
- NCT06882980
- Acronym / sponsor ID
- MCHH_008
- Conditions
- Adenotonsillectomy, Propofol, Ciprofol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Maternal and Child Health Hospital of Hubei ProvinceUniversity, hospital or other
- Study start
- 22 Feb 2025 (actual)
- Primary completion
- 22 Oct 2025 (estimated)
- Study completion
- 22 Nov 2025 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciprofol group | Experimental | Other: Ciprofol groupCiprofol group patients will be given ciprofol during anesthesia induction and maintenance |
| Propofol group | Active comparator | Other: Propofol groupPropofol group patients will be given propofol during anesthesia induction and maintenance |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ASA I/II, age 3-11 years, weight 13-50 kg.
- Endoscopic T\&A or adenoidectomy.
Key exclusion criteria (3 listed)
- Recent upper respiratory infection.
- Difficult airway, organ dysfunction, developmental/psychiatric disorders.
- Drug allergies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ciprofol groupIn 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. | Other | Ciprofol group |
| Propofol groupIn 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. | Other | Propofol group |
Primary outcome
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
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
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)
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)
7 secondary outcomes
Mean arterial pressure (MAP)
Time frame: intraoperative period,3 minutes-1 hour
Heart rate (HR)
Time frame: intraoperative period,3 minutes-1 hour
Recovery time
Time frame: Postoperative 1 minutes to 1.5hours
Dosage of anesthetic
Time frame: Intraoperative period, 20 minutes - 1.5 hours
anesthetist satisfaction
Time frame: Postoperative 30 minutes
Adverse events
Time frame: the procedure and Postoperative 24 hours
Pediatric Anesthesia Emergence Delirium (PAED) Scale
Time frame: Postoperative 1 minute-1hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Na Li, MD principal investigator
Maternal and Child Health Hospital of Hubei Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Na Li, MD (Telephone: Telephone:+86276349, Email:lina@hbfy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Induction Compliance checklist(ICC) (time frame: during the time of anesthesia induction ,1 minute-10 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.