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

October 18, 2023 updated by: The Second Affiliated Hospital of Hainan Medical University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hainan
      • Haikou, Hainan, China, 570311
        • Recruiting
        • The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Patients undergoing surgery with a single-lumen endotracheal tube placed under general anesthesia;
  2. American Society of Anesthesiologists(ASA grade) I or II;
  3. Age 18~65 years old;
  4. Body mass index (BMI) 18 to 28 kg/m2;
  5. Mallampati airway classification grade I or II;
  6. Acceptance of this experiment and signing of informed consent.

Exclusion Criteria:

  1. Patients with a history of alcoholism, allergy to any component of the product;
  2. 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;
  3. 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;
  4. 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;
  5. Neuropsychiatric abnormalities, communication and comprehension deficits exist;
  6. 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
  7. Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group C
Ciprofol + sufentanil + rocuronium bromide
Drug: Ciprofol
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
Other Names:
  • Ciprofol injection
Active Comparator: Group R
Remimazolam+ sufentanil + rocuronium bromide
Drug: Remimazolam
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
Other Names:
  • Remimazolam Tosylate for Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate(HR)
Time Frame: Intravenous ciprofol up to 3 minutes after tracheal intubation
Heart rate monitored with Dash4000 equipment
Intravenous ciprofol up to 3 minutes after tracheal intubation
Mean Arterial Pressure(MAP)
Time Frame: Intravenous ciprofol up to 3 minutes after tracheal intubation
Heart rate monitored with Dash4000 equipment
Intravenous ciprofol up to 3 minutes after tracheal intubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bispectral Index(BIS)
Time Frame: Intravenous ciprofol up to 3 minutes after tracheal intubation
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
Peripheral Oxygen Saturation(SPO2)
Time Frame: Intravenous ciprofol up to 3 minutes after tracheal intubation
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
Time Frame: Intravenous ciprofol to leave resuscitation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Affiliated Hospital of Hainan Medical University

Investigators

  • Study Chair: Hu Sun, The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China
  • Study Director: Min Liao, The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2022

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

September 30, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • RM20220701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Non-disclosure of raw data is not necessary

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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