Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group C | Experimental | Ciprofol + sufentanil + rocuronium bromide |
|
| Group R | Active Comparator | Remimazolam+ sufentanil + rocuronium bromide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofol | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate(HR) | Heart rate monitored with Dash4000 equipment | Intravenous ciprofol up to 3 minutes after tracheal intubation |
| Mean Arterial Pressure(MAP) | Heart rate monitored with Dash4000 equipment | Intravenous ciprofol up to 3 minutes after tracheal intubation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intravenous ciprofol up to 3 minutes after tracheal intubation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hu Sun | Contact | 13617518996 | sunhu09@163.com | |
| Min Liao | Contact | 13364015074 | liaomm97@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Hu Sun | The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China | Study Chair |
| Min Liao | The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China | Recruiting | Haikou | Hainan | 570311 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27185725 | Background | 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. | |
| 16211744 | Background | Kayhan 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. |
Not provided
Not provided
Non-disclosure of raw data is not necessary
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000730795 | (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol |
| C522201 | remimazolam |
| C573194 | 4-methylbenzenesulfonic acid |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Group C: Ciprofol + sufentanil + rocuronium bromide Group R: Remimazolam+ sufentanil + rocuronium bromide
Not provided
Not provided
People who were unaware of the experiment helped to randomize the groups and inject the test drug according to the groups, and the patients who participated in the experiment as well as the doctors were unaware of the groups.
|
|
| Remimazolam | Drug | 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 |
|
|
| Peripheral Oxygen Saturation(SPO2) | Monitored with Dash4000 equipment | 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. | Intravenous ciprofol to leave resuscitation |
| Xiaoru Wu | The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China | Principal Investigator |
| Jianing Hu | The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China | Principal Investigator |
| Xingzhou Lin | The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China | Principal Investigator |
| Tangyuanmeng Zhao | West China Hospital | Principal Investigator |
| 29406182 | Background | Higgs 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. |
| 18325887 | Background | Xue 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. |
| 20400005 | Background | Weisenberg 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. |
| 34916051 | Background | Sneyd 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. |
| 30857601 | Background | Hemphill 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. |
| 28430430 | Background | Qin 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. |
| 32415708 | Background | Bian 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. |
| 39805976 | Derived | Liao 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. |