Study on the Safety and Effectiveness of Cipepofol Compared to Propofol for General Anesthesia in Adults Undergoing Elective Surgery

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What is this study about?

This clinical trial is focused on evaluating the safety and effectiveness of a new medication called Cipepofol (also known by its code name HSK3486) for inducing general anesthesia in adults who are undergoing planned surgeries. General anesthesia is a medically induced state that allows patients to undergo surgery without feeling pain. The study compares Cipepofol to a commonly used anesthetic called Propofol to see if it works just as well or better.

Participants in the study will receive either Cipepofol or Propofol through an intravenous injection, which means the medication is given directly into a vein. The study aims to determine if Cipepofol can successfully induce anesthesia with minimal additional doses and without the need for other medications to help. The trial will also monitor for any pain at the injection site and ensure that the anesthesia is maintained at the right level without causing significant heart or breathing problems shortly after the medication is given.

Other medications involved in the study include Midazolam, Fentanyl, Sevoflurane, Rocuronium Bromide, and Dobutamine, which are used in various ways to support anesthesia and patient care during surgery. The study is designed to be double-blinded, meaning neither the participants nor the researchers know who is receiving which medication, to ensure unbiased results. The goal is to provide a safe and effective option for anesthesia in surgical procedures.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and surgical requirements.

Participants must be undergoing elective surgery that requires general anesthesia and endotracheal intubation.

2 preparation for anesthesia

Before the surgery, participants are prepared for anesthesia. This includes a preoperative evaluation by an anesthesiologist to ensure clinical status is optimized.

Vital signs are checked to ensure they are within the required range.

3 administration of study drug

The study involves the administration of HSK3486 or propofol to induce general anesthesia.

HSK3486 is given as a slow intravenous injection at a dose of 0.4 mg per kg of body weight. If needed, an additional dose of 0.2 mg per kg may be administered.

Propofol is administered as a slow intravenous injection at a dose of 2.0 mg per kg of body weight, with an additional 1.0 mg per kg if necessary.

4 monitoring during surgery

During the surgery, the depth of anesthesia is monitored to ensure it is maintained at the desired level.

The success of anesthesia induction is determined by achieving a specific level of sedation and requiring no more than one additional dose without using rescue drugs.

5 post-surgery observation

After the surgery, participants are transferred from the operating room to the recovery room.

Observation continues to monitor for any side effects, such as pain at the injection site or changes in cardiac and respiratory function.

Who Can Join the Study?

Patients must be having elective surgery, which means planned surgery that is not an emergency, not involving the heart or brain, and expected to last at least 1 hour. The surgery requires a breathing tube and general anesthesia using inhaled gases.
Participants can be male or female, aged 18 years or older. They should have an ASA-PS (American Society of Anesthesiologists Physical Status) classification of I to IV, which is a way to assess their health before surgery. If classified as IV, their health must be stable according to the anesthesiologist.
Participants must have a BMI (Body Mass Index) of 18 kg/m² or higher.
Vital signs at screening should be within these ranges: breathing rate between 10 and 24 breaths per minute, oxygen level in the blood (SpO2) 92% or higher, systolic blood pressure between 90 and 160 mmHg, diastolic blood pressure between 55 and 100 mmHg, and heart rate between 55 and 100 beats per minute (or 50 if on beta blockers).
Women who can have children must have a negative pregnancy test before the study and on the first day of the study. Both women and men with partners who can have children must agree to use effective birth control from the time they agree to join the study until 30 days after receiving the study drug.
Participants must be able to understand the study procedures, willing to sign a consent form, and able to follow the study rules.
Participants must agree to follow the site’s COVID-19 guidelines and testing requirements.
Patients with mental health conditions must be stable on their treatment, such as medications or therapy, and should not have been hospitalized or needed urgent care for their condition in the past 12 months.
For those with known or suspected thyroid issues, a TSH (Thyroid-Stimulating Hormone) test must be done, and the results should be normal.

Who Cannot Join the Study?

Patients who have allergies to any of the medications used in the study.
Patients with a history of severe reactions to anesthesia, which is a medicine used to make you sleep during surgery.
Patients with serious heart problems, as these can affect how the body handles anesthesia.
Patients with severe liver or kidney disease, as these organs help process medications in the body.
Patients who are pregnant or breastfeeding, as the effects on the baby are not known.
Patients with a history of drug or alcohol abuse, as this can affect how the body responds to medications.
Patients who are currently participating in another clinical trial, to avoid interference with study results.
Patients with any other condition that the study doctors believe would make it unsafe to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Pomeranian Medical University	Szczecin	Poland
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Uniwersytecki Szpital Kliniczny W Opolu	Opole	Poland
Hospital General Universitario De Ciudad Real	Ciudad Real	Spain
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Sawqjsibhmi Pvnzfvbrt Snopdyn Ksqpswmll Nx 1 Ibzxfavdsdqduhlgdm Skhoatx Spwblnvya Upcsjpgtbljj Mgnnttiggo W Kaeixbnwbd	Zabrze	Poland
Ushczkogpxsds Spxexvn Kxdezfgrk Nb 2 Pls W Sxmbxbxbql	Szczecin	Poland
Pnznduwrz Ieqykycd Mntfwwqi Msmcbjdhrmmu Sxsrp Wjghjbxrihem I Aaaxddarqoeud	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	01.02.2024
Spain	Not recruiting	01.02.2024

Trial locations

Investigated drugs:

HSK3486 is an injectable emulsion used to induce general anesthesia in adults who are undergoing elective surgery. It is administered through a slow injection into a vein. The goal of using HSK3486 in this trial is to determine if it is as effective and safe as another commonly used anesthetic in helping patients fall asleep before surgery.

Propofol is a widely used medication for inducing general anesthesia. It is also given as a slow injection into a vein. In this trial, propofol serves as the control medication, meaning its effects are compared to those of HSK3486 to see if the new medication works just as well for putting patients to sleep before surgery.

General Anesthesia – General anesthesia is a medically induced state of unconsciousness, where the patient is unable to feel pain during surgical procedures. It involves the administration of anesthetic drugs that affect the entire body, leading to a loss of awareness and sensation. The process begins with the induction phase, where the patient transitions from a conscious to an unconscious state. Once unconscious, the maintenance phase ensures the patient remains in this state for the duration of the surgery. The depth of anesthesia is carefully monitored to prevent any awareness or discomfort. After the procedure, the patient enters the recovery phase, gradually regaining consciousness and sensation.

Trial ID:

2023-507009-32-00

Protocol code:

HSK3486-309

NCT ID:

NCT05486416

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Effectiveness of Cipepofol Compared to Propofol for General Anesthesia in Adults Undergoing Elective Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?