Thyroid DiseaseNCT07294989

The Effective Blood Concentration of Ciprofol

An observational study of Thyroid Disease, run by Peking University Shenzhen Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial summary

1. Eligible patients were selected and enrolled in the study. 2. General anesthesia was induced using ciprofol in all participants, with standardized evaluation of consciousness levels during induction. 3. The patients' pain and cognition are followed up after surgery. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Thyroid Disease
What is being tested?: Ciprofol
Type of treatment: Injection or infusion
How many people: 101 participants
Where: 1 siteChina
Study dates: 1 Jul 2025to 30 Jun 2026
How long will I take part?: 1 Day
Phase: Observational
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients undergoing elective thyroidectomy at Peking University Shenzhen Hospital

Who may be able to join

Patients aged 18-65 years
Scheduled for elective thyroidectomy
ASA physical status classification I-II
Willing to participate and providing written informed consent

Who cannot join

Recent use of sedatives or opioid analgesics
Severe hepatic or renal dysfunction defined as:Child-Pugh class C (score ≥10), Creatinine clearance <35 mL/min ,Requiring preoperative dialysis
Significant cardiovascular comorbidities
Body mass index ≥35 kg/m² or <18.5 kg/m²
Known hypersensitivity or adverse reactions to propofol/ciprofol
Neuropsychiatric disorders including:Alzheimer's disease,History of cerebrovascular events,Traumatic brain injury,Space-occupying brain lesions,Other significant neurological deficits

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tao Luo contact

+86 135 1082 0779

496855048@qq.com

China1 site, 1 recruiting

Peking University Shenzhen Hospital
Shenzhen, Guangdong
Tao Luo, +86 135 1082 0779, 496855048@qq.com
Recruiting

Other trials in China

About this study

Official title: Median Effective Concentration of Ciprofol and Its Correlation With Bispectral Index: A Prospective Observational Study

Eligible patients were selected and enrolled in the study.
General anesthesia was induced using ciprofol in all participants, with standardized evaluation of consciousness levels during induction.
The patients' pain and cognition are followed up after surgery.

Conditions: Thyroid Disease
Being tested: Ciprofol
Medical subject headings: Thyroid Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CiprofolDrug
Beginning with an initial target plasma concentration of ciprofol at 1.2 μg/mL. Assessments of the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale and Bispectral Index (BIS) values are performed every minute until the patient achieves a complete anesthetic state (defined as an MOAA/S score of 0).

Study groups in NCT07294989
Study group	Role	What they receive
ciprofol group		Anesthesia induction was achieved through target-controlled infusion of ciprofol. Receives: Drug: Ciprofol

What is being measured

The primary outcome is the main question the study is designed to answer.

The effect-site concentration of cipofol, when MOAAS reaches 2
The effect-site concentration of cipofol corresponding to MOAA/S score (Modified Observer's Assessment of Alertness/Sedation) of 2.
(Modified Observer's Assessment of Alertness/Sedation: 5--Responds readily to name spoken in normal tone ； 4--Lethargic response to name spoken in normal tone ； 3--Responds only after name is called loudly and/or repeatedly ； 2--Responds only after mild prodding or shaking ；
1--Responds only after painful trapezius squeeze ； 0--No response after painful trapezius squeeze；)
Measured: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the effect-site concentration (Ce).

Secondary outcomes (5)

The effect-site concentration of cipofol, when MOAA/S reaches 0.
The effect-site concentration of cipofol corresponding to MOAA/S score (Modified Observer's Assessment of Alertness/Sedation) of 0.
Measured: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the effect-site concentration (Ce).
Bispectral index
Bispectral Index (BIS) values corresponding to different Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores.
Measured: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the BIS values.
The EC₅₀ and EC₉₅ of ciprofol
The EC₅₀ and EC₉₅ of ciprofol corresponding to MOAA/S scores of 2 and 0
Measured: From the beginning of anesthesia induction until 1 minute after intubation , the MOAA/S score was assessed every minute, with simultaneous recording of the effect-site concentration (Ce).
Heart rate
Heart rate(in bpm) corresponding to different Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores.
Measured: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the HR.
Blood pressure
The systolic blood pressure, diastolic blood pressure and mean arterial pressure corresponding to different MOAAS scores were all recorded.
Measured: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the systolic blood pressure, diastolic blood pressure and mean arterial pressure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202530 Jun 2026

First posted19 Dec 2025
Study start1 Jul 2025
Primary completion30 Jun 2026 (estimated)
Study completion30 Jun 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (32)Papers the sponsor has linked to this study.
Other trials for Thyroid DiseaseStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 101 participants (estimated)
Target duration: 1 Day

IDs, dates and publications

ClinicalTrials.gov ID: NCT07294989
Sponsor's protocol ID: 2025-117
Status last verified: Jun 2025
First submitted: 25 Jun 2025
Last updated: 6 Jan 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Glen JB. The development of 'Diprifusor': a TCI system for propofol. Anaesthesia. 1998 Apr;53 Suppl 1:13-21. doi: 10.1111/j.1365-2044.1998.53s115.x.
PubMed 9640110
Shafer SL, Gregg KM. Algorithms to rapidly achieve and maintain stable drug concentrations at the site of drug effect with a computer-controlled infusion pump. J Pharmacokinet Biopharm. 1992 Apr;20(2):147-69. doi: 10.1007/BF01070999.
PubMed 1629794
Absalom AR, Glen JI, Zwart GJ, Schnider TW, Struys MM. Target-Controlled Infusion: A Mature Technology. Anesth Analg. 2016 Jan;122(1):70-8. doi: 10.1213/ANE.0000000000001009.
PubMed 26516798
Zbinden AM, Maggiorini M, Petersen-Felix S, Lauber R, Thomson DA, Minder CE. Anesthetic depth defined using multiple noxious stimuli during isoflurane/oxygen anesthesia. I. Motor reactions. Anesthesiology. 1994 Feb;80(2):253-60. doi: 10.1097/00000542-199402000-00004.
PubMed 8311307
Smith C, McEwan AI, Jhaveri R, Wilkinson M, Goodman D, Smith LR, Canada AT, Glass PS. The interaction of fentanyl on the Cp50 of propofol for loss of consciousness and skin incision. Anesthesiology. 1994 Oct;81(4):820-8; discussion 26A.
PubMed 7943832
Eger EI 2nd, Saidman LJ, Brandstater B. Minimum alveolar anesthetic concentration: a standard of anesthetic potency. Anesthesiology. 1965 Nov-Dec;26(6):756-63. doi: 10.1097/00000542-196511000-00010. No abstract available.
PubMed 5844267
Gu Y, Hao J, Wang J, Liang P, Peng X, Qin X, Zhang Y, He D. Effectiveness Assessment of Bispectral Index Monitoring Compared with Conventional Monitoring in General Anesthesia: A Systematic Review and Meta-Analysis. Anesthesiol Res Pract. 2024 Aug 7;2024:5555481. doi: 10.1155/2024/5555481. eCollection 2024.
PubMed 39149130
Chiang MH, Wu SC, Hsu SW, Chin JC. Bispectral Index and non-Bispectral Index anesthetic protocols on postoperative recovery outcomes. Minerva Anestesiol. 2018 Feb;84(2):216-228. doi: 10.23736/S0375-9393.17.12033-X. Epub 2017 Oct 12.
PubMed 29027770
Rosow C, Manberg PJ. Bispectral index monitoring. Anesthesiol Clin North Am. 2001 Dec;19(4):947-66, xi. doi: 10.1016/s0889-8537(01)80018-3.
PubMed 11778388
Guo X, Qiao Y, Yin S, Luo F, Yi L, Chen J, Lu M. Pharmacokinetics and pharmacodynamics of ciprofol after continuous infusion in elderly patients. BMC Anesthesiol. 2025 Jan 27;25(1):41. doi: 10.1186/s12871-025-02907-4.
PubMed 39871139
Liu L, Wang K, Yang Y, Hu M, Chen M, Liu X, Yan P, Wu N, Xiang X. Population pharmacokinetic/pharmacodynamic modeling and exposure-response analysis of ciprofol in the induction and maintenance of general anesthesia in patients undergoing elective surgery: A prospective dose optimization study. J Clin Anesth. 2024 Feb;92:111317. doi: 10.1016/j.jclinane.2023.111317. Epub 2023 Nov 15.
PubMed 37976683
Irwin MG, Hui TW, Milne SE, Kenny GN. Propofol effective concentration 50 and its relationship to bispectral index. Anaesthesia. 2002 Mar;57(3):242-8. doi: 10.1046/j.0003-2409.2001.02446.x.
PubMed 11879213
Kateliya R, Madhukant, Dubey M, Chandra S, Sahay N. Comparison of recovery profiles in target-controlled infusions (TCI) versus manually controlled infusions for total intravenous anesthesia (TIVA) in laparoscopic surgeries. A randomized controlled trial. J Anaesthesiol Clin Pharmacol. 2023 Apr-Jun;39(2):258-263. doi: 10.4103/joacp.joacp_396_21. Epub 2023 Apr 19.
PubMed 37564857
Mu J, Jiang T, Xu XB, Yuen VM, Irwin MG. Comparison of target-controlled infusion and manual infusion for propofol anaesthesia in children. Br J Anaesth. 2018 May;120(5):1049-1055. doi: 10.1016/j.bja.2017.11.102. Epub 2018 Feb 3.
PubMed 29661382
Hu C, Horstman DJ, Shafer SL. Variability of target-controlled infusion is less than the variability after bolus injection. Anesthesiology. 2005 Mar;102(3):639-45. doi: 10.1097/00000542-200503000-00024.
PubMed 15731604

Interested in taking part?

Tao Luo

+86 135 1082 0779

496855048@qq.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Thyroid Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Median Effective Concentration of Ciprofol and Its Correlation With Bispectral Index: A Prospective Observational Study
ClinicalTrials.gov ID: NCT07294989
Acronym / sponsor ID: 2025-117
Conditions: Thyroid Disease
Study type: Observational
Recruitment status: Recruiting
Enrolment: 101 participants (estimated)
Lead sponsor: Peking University Shenzhen HospitalUniversity, hospital or other
Study start: 1 Jul 2025 (actual)
Primary completion: 30 Jun 2026 (estimated)
Study completion: 30 Jun 2026 (estimated)
First posted: 19 Dec 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.

Eligible patients were selected and enrolled in the study.
General anesthesia was induced using ciprofol in all participants, with standardized evaluation of consciousness levels during induction.
The patients' pain and cognition are followed up after surgery.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 1 Day
Number of arms: 1

Arm	Type	Receives
ciprofol group	–	Drug: CiprofolAnesthesia induction was achieved through target-controlled infusion of ciprofol.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients undergoing elective thyroidectomy at Peking University Shenzhen Hospital

Key inclusion criteria (4 listed)

Patients aged 18-65 years
Scheduled for elective thyroidectomy
ASA physical status classification I-II
Willing to participate and providing written informed consent

Key exclusion criteria (6 listed)

Recent use of sedatives or opioid analgesics
Severe hepatic or renal dysfunction defined as:Child-Pugh class C (score ≥10), Creatinine clearance <35 mL/min ,Requiring preoperative dialysis
Significant cardiovascular comorbidities
Body mass index ≥35 kg/m² or <18.5 kg/m²
Known hypersensitivity or adverse reactions to propofol/ciprofol

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
CiprofolBeginning with an initial target plasma concentration of ciprofol at 1.2 μg/mL. Assessments of the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale and Bispectral Index (BIS) values are performed every minute until the patient achieves a complete anesthetic state (defined as an MOAA/S score of 0).	Drug	ciprofol group

Primary outcome

The effect-site concentration of cipofol, when MOAAS reaches 2
Time frame: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the effect-site concentration (Ce).
The effect-site concentration of cipofol corresponding to MOAA/S score (Modified Observer's Assessment of Alertness/Sedation) of 2. (Modified Observer's Assessment of Alertness/Sedation: 5--Responds readily to name spoken in normal tone ； 4--Lethargic response to name spoken in normal tone ； 3--Responds only after name is called loudly and/or repeatedly ； 2--Responds only after mild prodding or shaking ； 1--Responds only after painful trapezius squeeze ； 0--No response after painful trapezius squeeze；)

5 secondary outcomes

The effect-site concentration of cipofol, when MOAA/S reaches 0.
Time frame: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the effect-site concentration (Ce).
Bispectral index
Time frame: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the BIS values.
The EC₅₀ and EC₉₅ of ciprofol
Time frame: From the beginning of anesthesia induction until 1 minute after intubation , the MOAA/S score was assessed every minute, with simultaneous recording of the effect-site concentration (Ce).
Heart rate
Time frame: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the HR.
Blood pressure
Time frame: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the systolic blood pressure, diastolic blood pressure and mean arterial pressure.

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 6 Jan 2026.
Background: PubMed 9640110Glen JB. The development of 'Diprifusor': a TCI system for propofol. Anaesthesia. 1998 Apr;53 Suppl 1:13-21. doi: 10.1111/j.1365-2044.1998.53s115.x.
Background: PubMed 1629794Shafer SL, Gregg KM. Algorithms to rapidly achieve and maintain stable drug concentrations at the site of drug effect with a computer-controlled infusion pump. J Pharmacokinet Biopharm. 1992 Apr;20(2):147-69. doi: 10.1007/BF01070999.
Background: PubMed 26516798Absalom AR, Glen JI, Zwart GJ, Schnider TW, Struys MM. Target-Controlled Infusion: A Mature Technology. Anesth Analg. 2016 Jan;122(1):70-8. doi: 10.1213/ANE.0000000000001009.
Background: PubMed 8311307Zbinden AM, Maggiorini M, Petersen-Felix S, Lauber R, Thomson DA, Minder CE. Anesthetic depth defined using multiple noxious stimuli during isoflurane/oxygen anesthesia. I. Motor reactions. Anesthesiology. 1994 Feb;80(2):253-60. doi: 10.1097/00000542-199402000-00004.
Background: PubMed 7943832Smith C, McEwan AI, Jhaveri R, Wilkinson M, Goodman D, Smith LR, Canada AT, Glass PS. The interaction of fentanyl on the Cp50 of propofol for loss of consciousness and skin incision. Anesthesiology. 1994 Oct;81(4):820-8; discussion 26A.
Background: PubMed 5844267Eger EI 2nd, Saidman LJ, Brandstater B. Minimum alveolar anesthetic concentration: a standard of anesthetic potency. Anesthesiology. 1965 Nov-Dec;26(6):756-63. doi: 10.1097/00000542-196511000-00010. No abstract available.
Background: PubMed 39149130Gu Y, Hao J, Wang J, Liang P, Peng X, Qin X, Zhang Y, He D. Effectiveness Assessment of Bispectral Index Monitoring Compared with Conventional Monitoring in General Anesthesia: A Systematic Review and Meta-Analysis. Anesthesiol Res Pract. 2024 Aug 7;2024:5555481. doi: 10.1155/2024/5555481. eCollection 2024.
Background: PubMed 29027770Chiang MH, Wu SC, Hsu SW, Chin JC. Bispectral Index and non-Bispectral Index anesthetic protocols on postoperative recovery outcomes. Minerva Anestesiol. 2018 Feb;84(2):216-228. doi: 10.23736/S0375-9393.17.12033-X. Epub 2017 Oct 12.
Background: PubMed 11778388Rosow C, Manberg PJ. Bispectral index monitoring. Anesthesiol Clin North Am. 2001 Dec;19(4):947-66, xi. doi: 10.1016/s0889-8537(01)80018-3.
Results publication: PubMed 39871139Guo X, Qiao Y, Yin S, Luo F, Yi L, Chen J, Lu M. Pharmacokinetics and pharmacodynamics of ciprofol after continuous infusion in elderly patients. BMC Anesthesiol. 2025 Jan 27;25(1):41. doi: 10.1186/s12871-025-02907-4.
Results publication: PubMed 37976683Liu L, Wang K, Yang Y, Hu M, Chen M, Liu X, Yan P, Wu N, Xiang X. Population pharmacokinetic/pharmacodynamic modeling and exposure-response analysis of ciprofol in the induction and maintenance of general anesthesia in patients undergoing elective surgery: A prospective dose optimization study. J Clin Anesth. 2024 Feb;92:111317. doi: 10.1016/j.jclinane.2023.111317. Epub 2023 Nov 15.
Results publication: PubMed 11879213Irwin MG, Hui TW, Milne SE, Kenny GN. Propofol effective concentration 50 and its relationship to bispectral index. Anaesthesia. 2002 Mar;57(3):242-8. doi: 10.1046/j.0003-2409.2001.02446.x.

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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.

Tao Luo contact

+86 135 1082 0779

496855048@qq.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Thyroid Disease, run by Peking University Shenzhen Hospital 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 4 inclusion and 6 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 6 Jan 2026. 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 Tao Luo (+86 135 1082 0779, 496855048@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The effect-site concentration of cipofol, when MOAAS reaches 2 (time frame: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the effect-site concentration (Ce).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07294989, which also lists 32 linked publications.

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 6 Jan 2026.