The Study of Ciprofol for the Suppression of Cardiovascular Responses to Tracheal Intubation

NCT06095570 | Unknown Phase 4

• 1 other identifier: RM20220701
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Intubation, Intratracheal; Adverse Effects

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Bispectral Index(BIS)

  Intravenous ciprofol up to 3 minutes after tracheal intubation

• Peripheral Oxygen Saturation(SPO2)

  Intravenous ciprofol up to 3 minutes after tracheal intubation

• Rate of respiratory inhibition,Injection pain,Hypotension,Allergy,Bradycardia,Muscle tremor,Postoperative nausea and vomiting

  Intravenous ciprofol to leave resuscitation

Study Arms (2)

Group C

EXPERIMENTAL

Ciprofol + sufentanil + rocuronium bromide

Drug: Ciprofol

Group R

ACTIVE COMPARATOR

Remimazolam+ sufentanil + rocuronium bromide

Drug: Remimazolam

Interventions

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

Also known as: Ciprofol injection

Group C

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

Also known as: Remimazolam Tosylate for Injection

Group R

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Hainan Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China

Haikou, Hainan, 570311, China

RECRUITING

Related Publications (10)

• 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.

  PMID: 27185725 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.

  PMID: 16211744 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.

  PMID: 29406182 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.

  PMID: 18325887 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.

  PMID: 20400005 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.

  PMID: 34916051 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.

  PMID: 30857601 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.

  PMID: 28430430 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.

  PMID: 32415708 BACKGROUND

• 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.

  PMID: 39805976 DERIVED

MeSH Terms

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol; remimazolam; 4-methylbenzenesulfonic acid; Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• 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

• 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

Central Study Contacts

Hu Sun

CONTACT

13617518996; sunhu09@163.com

Min Liao

CONTACT

13364015074; liaomm97@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group C: Ciprofol + sufentanil + rocuronium bromide Group R: Remimazolam+ sufentanil + rocuronium bromide

Study Record Dates

• First Submitted: September 30, 2023
• First Posted: October 23, 2023
• Study Start: July 23, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)