Intubation, IntratrachealPhase 4NCT06095570
The Study of Ciprofol for the Suppression of Cardiovascular Responses to Tracheal Intubation
A Phase 4 study testing Ciprofol and Remimazolam in people with Intubation, Intratracheal and Adverse Effects, run by The Second Affiliated Hospital of Hainan Medical University at 1 site in China.
Trial summary
Preliminary studies have illuminated the promising nature of ciprofol, indicating its enhanced safety spectrum, superior potency, and a diminished likelihood of experiencing injection-related discomfort. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation, Intratracheal, Adverse Effects
- What is being tested?
- Ciprofol and Remimazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2022to 30 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing surgery with a single-lumen endotracheal tube placed under general anesthesia;
- American Society of Anesthesiologists(ASA grade) I or II;
- Age 18~65 years old;
- Body mass index (BMI) 18 to 28 kg/m2;
- Mallampati airway classification grade I or II;
- Acceptance of this experiment and signing of informed consent.
Who cannot join
- Patients with a history of alcoholism, allergy to any component of the product;
- Patients with severe heart, lung and brain vital organ diseases, such as acute heart attack, cerebral infarction, asthma, chronic obstructive pulmonary disease and other medical history;
- Serious liver and kidney function abnormalities or combined serious endocrine dysfunction, such as hypertension (systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 110 mmHg, HR ≥ 110 beats/min), diabetes mellitus, hyperthyroidism, hypothyroidism and so on;
- Difficult airway (mouth opening less than 3 cross fingers, those with Mallampati score grade III or IV, difficulty in vocal valve exposure, difficulty in tracheal intubation, unsuccessful in one attempt); oropharyngeal and cervical deformities or history of previous tracheotomy;
- Neuropsychiatric abnormalities, communication and comprehension deficits exist;
- History of long-term sedative and analgesic medications, drug and opioid addiction, and heart rate control medications (e.g., beta blockers, alpha agonists, calcium channel blockers); and
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China
Haikou, Hainan, 570311
min liao, Master, 13364015074, liaomm97@qq.com
hu sun, Master, +86 136 1751 8996, sunhu09@163.com
About this study
Official title: The Study of Ciprofol for the Suppression of Cardiovascular Responses to Tracheal
Preliminary studies have illuminated the promising nature of ciprofol, indicating its enhanced safety spectrum, superior potency, and a diminished likelihood of experiencing injection-related discomfort. Venturing deeper, this research embarked on an ambitious quest to measure the 95% effective volume of ciprofol for induction of general anesthesia by a modified sequential method and juxtapose the 95% effective volume dosage of ciprofol against a corresponding dose of remimazolam during the initiation of general anesthesia. The study delved into diverse anesthetic protocols, meticulously scrutinizing the safety and efficacy credentials of ciprofol. The ultimate vision was to pave a robust foundation for the sophisticated and judicious utilization of ciprofol in clinical landscapes.
Read the detailed description
During general anesthesia induction, tracheal intubation is a significant procedure that can cause cardiovascular fluctuations due to the stimulation of tracheal receptors. This can lead to complications such as imbalances in vital organ oxygen supply, especially in patients with cardiovascular and cerebrovascular disorders, potentially resulting in cardiac arrest. As the demand for anesthetics rises in clinical settings, some, due to extreme side effects, have been phased out, reducing the available options.
Propofol, a common anesthetic, is effective and quick but has drawbacks like injection pain and risks associated with long-term use. In contrast, ciprofol, a new class I intravenous anesthetic, is emerging as a potentially better alternative. Early research indicates that ciprofol might have a broader safety margin than propofol and offers benefits like rapid recovery and lower chances of injection pain.
Exhaustive studies on the precise dosage of ciprofol for surgical applications are scarce and comparisons between ciprofol and remimazolam are rarely reported in the literature. This research aims to bridge this knowledge gap, exploring the best dosage for tracheal intubation sedation, and ensuring patients get the most effective and safest anesthetic care.
- Conditions
- Intubation, Intratracheal, Adverse Effects
- Being tested
- Ciprofol, Remimazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofolDrug
Also called Ciprofol injection
For induction of anesthesia, an experimental dose of ciprofol was given, and when the patient lost consciousness and the Modified Observer's Alertness/Sedation scale(MOAA/S score) was less than 1, then intravenous sufentanil and rocuronium bromide were administered, and tracheal intubation was performed 3 minutes later
RemimazolamDrug
Also called Remimazolam Tosylate for Injection
For induction of anesthesia, an experimental dose of remimazolam was given, and when the patient lost consciousness and the Modified Observer's Alertness/Sedation scale(MOAA/S score) was less than 1, then intravenous sufentanil and rocuronium bromide were administered, and tracheal intubation was performed 3 minutes later
| Study group | Role | What they receive |
|---|---|---|
| Group C | Experimental | Ciprofol + sufentanil + rocuronium bromide Receives: Drug: Ciprofol |
| Group R | Active comparator | Remimazolam+ sufentanil + rocuronium bromide Receives: Drug: Remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate(HR)
Heart rate monitored with Dash4000 equipment
Measured: Intravenous ciprofol up to 3 minutes after tracheal intubation
Mean Arterial Pressure(MAP)
Heart rate monitored with Dash4000 equipment
Measured: Intravenous ciprofol up to 3 minutes after tracheal intubation
Secondary outcomes (3)
Bispectral Index(BIS)
Monitored woth Bispectral Index Vista. BIS ranges from 0-100, with 100 representing full wakefulness and 0 representing complete cortical electroencephalogram(EEG) suppression; the smaller the value, the deeper the depth of sedation Mild sedation is BIS 65-85, and deep sedation is BIS 40-60, with primitive EEG bursts of suppression when BIS < 40.
Measured: Intravenous ciprofol up to 3 minutes after tracheal intubation
Peripheral Oxygen Saturation(SPO2)
Monitored with Dash4000 equipment
Measured: Intravenous ciprofol up to 3 minutes after tracheal intubation
Rate of respiratory inhibition,Injection pain,Hypotension,Allergy,Bradycardia,Muscle tremor,Postoperative nausea and vomiting
Referring to the standards in ciprofol's Phase III trial, the adverse reactions were defined as follows: (1) hypoxemia (oxygen saturation < 90% for > 30 s); (2) bradycardia (HR < 45/min for > 30 s); (3) hypotension (systolic BP decreased by 30% from the baseline value for > 2 min); and (4) pain at the injection site during ciprofol administration, evaluated by a study-blinded investigator using a 4-point verbal rating scale.
Measured: Intravenous ciprofol to leave resuscitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start23 Jul 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Intubation, IntratrachealStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group C: Ciprofol + sufentanil + rocuronium bromide Group R: Remimazolam+ sufentanil + rocuronium bromide
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Hainan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hu Sun, Study chair, The Second Affiliated Hospital of Hainan Medical University, Hai Kou, ChinaMin Liao, Study director, The Second Affiliated Hospital of Hainan Medical University, Hai Kou, ChinaXiaoru Wu, Principal investigator, The Second Affiliated Hospital of Hainan Medical University, Hai Kou, ChinaJianing Hu, Principal investigator, The Second Affiliated Hospital of Hainan Medical University, Hai Kou, ChinaXingzhou Lin, Principal investigator, The Second Affiliated Hospital of Hainan Medical University, Hai Kou, ChinaTangyuanmeng Zhao, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095570
- Sponsor's protocol ID
- RM20220701
- Status last verified
- Sep 2023
- First submitted
- 30 Sep 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Non-disclosure of raw data is not necessary
Publications
El-Shmaa NS, El-Baradey GF. The efficacy of labetalol vs dexmedetomidine for attenuation of hemodynamic stress response to laryngoscopy and endotracheal intubation. J Clin Anesth. 2016 Jun;31:267-73. doi: 10.1016/j.jclinane.2016.01.037. Epub 2016 Apr 18.
PubMed 27185725Kayhan Z, Aldemir D, Mutlu H, Ogus E. Which is responsible for the haemodynamic response due to laryngoscopy and endotracheal intubation? Catecholamines, vasopressin or angiotensin? Eur J Anaesthesiol. 2005 Oct;22(10):780-5. doi: 10.1017/s0265021505001298.
PubMed 16211744Higgs A, McGrath BA, Goddard C, Rangasami J, Suntharalingam G, Gale R, Cook TM; Difficult Airway Society; Intensive Care Society; Faculty of Intensive Care Medicine; Royal College of Anaesthetists. Guidelines for the management of tracheal intubation in critically ill adults. Br J Anaesth. 2018 Feb;120(2):323-352. doi: 10.1016/j.bja.2017.10.021. Epub 2017 Nov 26.
PubMed 29406182Xue FS, Xu YC, Liu Y, Yang QY, Liao X, Liu HP, Zhang YM, Liu JH, Luo MP. Different small-dose sufentanil blunting cardiovascular responses to laryngoscopy and intubation in children: a randomized, double-blind comparison. Br J Anaesth. 2008 May;100(5):717-23. doi: 10.1093/bja/aen032. Epub 2008 Mar 5.
PubMed 18325887Weisenberg M, Sessler DI, Tavdi M, Gleb M, Ezri T, Dalton JE, Protianov M, Zimlichmann R. Dose-dependent hemodynamic effects of propofol induction following brotizolam premedication in hypertensive patients taking angiotensin-converting enzyme inhibitors. J Clin Anesth. 2010 May;22(3):190-5. doi: 10.1016/j.jclinane.2009.07.008.
PubMed 20400005Sneyd JR, Absalom AR, Barends CRM, Jones JB. Hypotension during propofol sedation for colonoscopy: a retrospective exploratory analysis and meta-analysis. Br J Anaesth. 2022 Apr;128(4):610-622. doi: 10.1016/j.bja.2021.10.044. Epub 2021 Dec 13.
PubMed 34916051Hemphill S, McMenamin L, Bellamy MC, Hopkins PM. Propofol infusion syndrome: a structured literature review and analysis of published case reports. Br J Anaesth. 2019 Apr;122(4):448-459. doi: 10.1016/j.bja.2018.12.025. Epub 2019 Feb 6.
PubMed 30857601Qin L, Ren L, Wan S, Liu G, Luo X, Liu Z, Li F, Yu Y, Liu J, Wei Y. Design, Synthesis, and Evaluation of Novel 2,6-Disubstituted Phenol Derivatives as General Anesthetics. J Med Chem. 2017 May 11;60(9):3606-3617. doi: 10.1021/acs.jmedchem.7b00254. Epub 2017 Apr 28.
PubMed 28430430Bian Y, Zhang H, Ma S, Jiao Y, Yan P, Liu X, Ma S, Xiong Y, Gu Z, Yu Z, Huang C, Miao L. Mass balance, pharmacokinetics and pharmacodynamics of intravenous HSK3486, a novel anaesthetic, administered to healthy subjects. Br J Clin Pharmacol. 2021 Jan;87(1):93-105. doi: 10.1111/bcp.14363. Epub 2020 Aug 3.
PubMed 32415708Liao M, Wu XR, Hu JN, Lin XZ, Zhao TY, Sun H. Comparative effective dose of ciprofol and propofol in suppressing cardiovascular responses to tracheal intubation. Sci Rep. 2025 Jan 13;15(1):1822. doi: 10.1038/s41598-025-85968-2.
PubMed 39805976
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Ciprofol for the Suppression of Cardiovascular Responses to Tracheal
- ClinicalTrials.gov ID
- NCT06095570
- Acronym / sponsor ID
- RM20220701
- Conditions
- Intubation, Intratracheal, Adverse Effects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Hainan Medical UniversityUniversity, hospital or other
- Study start
- 23 Jul 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 23 Oct 2023 (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.
Preliminary studies have illuminated the promising nature of ciprofol, indicating its enhanced safety spectrum, superior potency, and a diminished likelihood of experiencing injection-related discomfort. Venturing deeper, this research embarked on an ambitious quest to measure the 95% effective volume of ciprofol for induction of general anesthesia by a modified sequential method and juxtapose the 95% effective volume dosage of ciprofol against a corresponding dose of remimazolam during the initiation of general anesthesia. The study delved into diverse anesthetic protocols, meticulously scrutinizing the safety and efficacy credentials of ciprofol. The ultimate vision was to pave a robust foundation for the sophisticated and judicious utilization of ciprofol in clinical landscapes.
Detailed description
During general anesthesia induction, tracheal intubation is a significant procedure that can cause cardiovascular fluctuations due to the stimulation of tracheal receptors. This can lead to complications such as imbalances in vital organ oxygen supply, especially in patients with cardiovascular and cerebrovascular disorders, potentially resulting in cardiac arrest. As the demand for anesthetics rises in clinical settings, some, due to extreme side effects, have been phased out, reducing the available options.
Propofol, a common anesthetic, is effective and quick but has drawbacks like injection pain and risks associated with long-term use. In contrast, ciprofol, a new class I intravenous anesthetic, is emerging as a potentially better alternative. Early research indicates that ciprofol might have a broader safety margin than propofol and offers benefits like rapid recovery and lower chances of injection pain.
Exhaustive studies on the precise dosage of ciprofol for surgical applications are scarce and comparisons between ciprofol and remimazolam are rarely reported in the literature. This research aims to bridge this knowledge gap, exploring the best dosage for tracheal intubation sedation, and ensuring patients get the most effective and safest anesthetic care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Group C: Ciprofol + sufentanil + rocuronium bromide Group R: Remimazolam+ sufentanil + rocuronium bromide
| Arm | Type | Receives |
|---|---|---|
| Group C | Experimental | Drug: CiprofolCiprofol + sufentanil + rocuronium bromide |
| Group R | Active comparator | Drug: RemimazolamRemimazolam+ sufentanil + rocuronium bromide |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients undergoing surgery with a single-lumen endotracheal tube placed under general anesthesia;
- American Society of Anesthesiologists(ASA grade) I or II;
- Age 18~65 years old;
- Body mass index (BMI) 18 to 28 kg/m2;
- Mallampati airway classification grade I or II;
Key exclusion criteria (7 listed)
- Patients with a history of alcoholism, allergy to any component of the product;
- Patients with severe heart, lung and brain vital organ diseases, such as acute heart attack, cerebral infarction, asthma, chronic obstructive pulmonary disease and other medical history;
- Serious liver and kidney function abnormalities or combined serious endocrine dysfunction, such as hypertension (systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 110 mmHg, HR ≥ 110 beats/min), diabetes mellitus, hyperthyroidism, hypothyroidism and so on;
- Difficult airway (mouth opening less than 3 cross fingers, those with Mallampati score grade III or IV, difficulty in vocal valve exposure, difficulty in tracheal intubation, unsuccessful in one attempt); oropharyngeal and cervical deformities or history of previous tracheotomy;
- Neuropsychiatric abnormalities, communication and comprehension deficits exist;
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 |
|---|---|---|
| CiprofolAlso: Ciprofol injectionFor induction of anesthesia, an experimental dose of ciprofol was given, and when the patient lost consciousness and the Modified Observer's Alertness/Sedation scale(MOAA/S score) was less than 1, then intravenous sufentanil and rocuronium bromide were administered, and tracheal intubation was performed 3 minutes later | Drug | Group C |
| RemimazolamAlso: Remimazolam Tosylate for InjectionFor induction of anesthesia, an experimental dose of remimazolam was given, and when the patient lost consciousness and the Modified Observer's Alertness/Sedation scale(MOAA/S score) was less than 1, then intravenous sufentanil and rocuronium bromide were administered, and tracheal intubation was performed 3 minutes later | Drug | Group R |
Primary outcome
Heart Rate(HR)
Time frame: Intravenous ciprofol up to 3 minutes after tracheal intubation
Heart rate monitored with Dash4000 equipment
Mean Arterial Pressure(MAP)
Time frame: Intravenous ciprofol up to 3 minutes after tracheal intubation
Heart rate monitored with Dash4000 equipment
3 secondary outcomes
Bispectral Index(BIS)
Time frame: Intravenous ciprofol up to 3 minutes after tracheal intubation
Peripheral Oxygen Saturation(SPO2)
Time frame: Intravenous ciprofol up to 3 minutes after tracheal intubation
Rate of respiratory inhibition,Injection pain,Hypotension,Allergy,Bradycardia,Muscle tremor,Postoperative nausea and vomiting
Time frame: Intravenous ciprofol to leave resuscitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Background: PubMed 27185725El-Shmaa NS, El-Baradey GF. The efficacy of labetalol vs dexmedetomidine for attenuation of hemodynamic stress response to laryngoscopy and endotracheal intubation. J Clin Anesth. 2016 Jun;31:267-73. doi: 10.1016/j.jclinane.2016.01.037. Epub 2016 Apr 18.
- Background: PubMed 16211744Kayhan Z, Aldemir D, Mutlu H, Ogus E. Which is responsible for the haemodynamic response due to laryngoscopy and endotracheal intubation? Catecholamines, vasopressin or angiotensin? Eur J Anaesthesiol. 2005 Oct;22(10):780-5. doi: 10.1017/s0265021505001298.
- Background: PubMed 29406182Higgs A, McGrath BA, Goddard C, Rangasami J, Suntharalingam G, Gale R, Cook TM; Difficult Airway Society; Intensive Care Society; Faculty of Intensive Care Medicine; Royal College of Anaesthetists. Guidelines for the management of tracheal intubation in critically ill adults. Br J Anaesth. 2018 Feb;120(2):323-352. doi: 10.1016/j.bja.2017.10.021. Epub 2017 Nov 26.
- Background: PubMed 18325887Xue FS, Xu YC, Liu Y, Yang QY, Liao X, Liu HP, Zhang YM, Liu JH, Luo MP. Different small-dose sufentanil blunting cardiovascular responses to laryngoscopy and intubation in children: a randomized, double-blind comparison. Br J Anaesth. 2008 May;100(5):717-23. doi: 10.1093/bja/aen032. Epub 2008 Mar 5.
- Background: PubMed 20400005Weisenberg M, Sessler DI, Tavdi M, Gleb M, Ezri T, Dalton JE, Protianov M, Zimlichmann R. Dose-dependent hemodynamic effects of propofol induction following brotizolam premedication in hypertensive patients taking angiotensin-converting enzyme inhibitors. J Clin Anesth. 2010 May;22(3):190-5. doi: 10.1016/j.jclinane.2009.07.008.
- Background: PubMed 34916051Sneyd JR, Absalom AR, Barends CRM, Jones JB. Hypotension during propofol sedation for colonoscopy: a retrospective exploratory analysis and meta-analysis. Br J Anaesth. 2022 Apr;128(4):610-622. doi: 10.1016/j.bja.2021.10.044. Epub 2021 Dec 13.
- Background: PubMed 30857601Hemphill S, McMenamin L, Bellamy MC, Hopkins PM. Propofol infusion syndrome: a structured literature review and analysis of published case reports. Br J Anaesth. 2019 Apr;122(4):448-459. doi: 10.1016/j.bja.2018.12.025. Epub 2019 Feb 6.
- Background: PubMed 28430430Qin L, Ren L, Wan S, Liu G, Luo X, Liu Z, Li F, Yu Y, Liu J, Wei Y. Design, Synthesis, and Evaluation of Novel 2,6-Disubstituted Phenol Derivatives as General Anesthetics. J Med Chem. 2017 May 11;60(9):3606-3617. doi: 10.1021/acs.jmedchem.7b00254. Epub 2017 Apr 28.
- Background: PubMed 32415708Bian Y, Zhang H, Ma S, Jiao Y, Yan P, Liu X, Ma S, Xiong Y, Gu Z, Yu Z, Huang C, Miao L. Mass balance, pharmacokinetics and pharmacodynamics of intravenous HSK3486, a novel anaesthetic, administered to healthy subjects. Br J Clin Pharmacol. 2021 Jan;87(1):93-105. doi: 10.1111/bcp.14363. Epub 2020 Aug 3.
- Derived from this study: PubMed 39805976Liao M, Wu XR, Hu JN, Lin XZ, Zhao TY, Sun H. Comparative effective dose of ciprofol and propofol in suppressing cardiovascular responses to tracheal intubation. Sci Rep. 2025 Jan 13;15(1):1822. doi: 10.1038/s41598-025-85968-2.
- Individual participant dataSharing planned: No. Non-disclosure of raw data is not necessary
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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. This study is not recruiting at the moment.
Hu Sun study chair
The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China
Min Liao study director
The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China
Xiaoru Wu principal investigator
The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ciprofol and Remimazolam in people with Intubation, Intratracheal and Adverse Effects, run by The Second Affiliated Hospital of Hainan Medical University 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hu Sun (13617518996, sunhu09@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate(HR) (time frame: Intravenous ciprofol up to 3 minutes after tracheal intubation). The study lists 2 primary outcomes in all. 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 NCT06095570, which also lists 10 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 23 Oct 2023.