Trial name
|
Efficacy and safety of HSK3486 for the induction and maintenance of
general anesthesia in elective surgical patients: a multicenter,
randomized, open-label, propofol-controlled phase 2 clinical trial
|
Efficacy and safety of ciprofol vs. propofol for the induction and
maintenance of general anesthesia
A multicenter, single-blind, randomized, parallel-group, phase 3
clinical trial
|
Study on the effectiveness and safety of ciprofol in anesthesia in
gynecological day surgery: a randomized double-blind controlled
study
|
The efficacy and safety of ciprofol use for the induction of general
anesthesia in patients undergoing gynecological surgery: a prospective
randomized controlled study
|
Effect of ciprofol on induction and maintenance of general anesthesia in
patients undergoing kidney transplantation
|
Effects of ciprofol for the induction of general anesthesia in patients
scheduled for elective surgery compared to propofol: a phase 3,
multicenter, randomized, double-blind, comparative study
|
Patient no. |
40 |
129 |
128 |
120 |
120 |
176 |
Year of publication |
2022 |
2023 |
2023 |
2022 |
2022 |
2022 |
Trial type |
a multicenter, randomized, open-label,
propofol-controlled phase 2 clinical trial |
A multicenter,
single-blind, randomized, parallel-group, phase 3 clinical trial |
a
randomized double-blind controlled study |
a prospective randomized
controlled study |
prospective, randomized, single-blind study |
A
multi-center, randomized, propofol-controlled, double-blind
trial |
Trial number |
NCT04048811 |
NCT04511728. |
ChiCTR2100053444 |
ChiCTR2100045211 |
ChiCTR2200058826 |
NCT03808844 |
Inclusion criteria
|
Age 18 -65 years old.
An American Society of Anesthesiologists (ASA) rating of Class I-III,
endotracheally intubated under GA, and a blood loss of ≤ 1,000 mL were
included.
|
(American Society of Anesthesiologists (ASA) classes I to II); age
≥18 years and ≤65 years;
|
Age (18 ~ 64years), with American Society of
Anesthesiologists physical classification status I or II, BMI 18 to
28 kg/m2.
|
Adult females between the ages of 18 to 60 (ASA physical status: I or
II) who were scheduled to undergo elective gynecological surgery under
GA.
|
Patients who had a kidney transplant under GA with tracheal intubation.
Age 18-65 years, (BMI) of 18-30 kg/m2 American Society of Anesthesiology
(ASA) physical status of III-IV.
|
Age 18-64 years
(BMI) between 18 and 30 kg/m2, American Society of Anesthesiologists
physical status of I or II
scheduled to undergo elective surgery under HA
|
Exclusion criteria
|
Scheduled to receive emergency, surgical procedures with
contraindications to GA or with a history of previous anesthesia
incidents were excluded.
|
Contraindications to GA; a history of anesthesia incidents; a disease
history of diseases or issues in any systems that could increase the
risk of sedation/anesthesia.
|
Patients were excluded if they suffered from propofol allergies, had
significant diseases in various systems Women who were pregnant, or
planning to become pregnant were excluded.
|
morbid obesity, egg/soy allergies, had significant diseases in various
systems. Women who were pregnant, lactating, or planning to become
pregnant within 1 month after the trial were excluded.
|
patients with liver, mental, nervous system diseases, coagulation
dysfunctions, heart failure, respiratory failure, long-term use of
sedatives or antidepressants, pregnant or lactating women, and unable to
communicate or cooperate.
|
a history of allergy or hypersensitivity. Those who had clinically
significant systemic diseases; pregnant or had a pregnancy plan within 1
month postoperatively; a family history of malignant hyperthermia; those
who had surgery under GA within 4 weeks perioperatively;
who had previously received sedative/narcotic agents within 3 days of
screening and had alcohol or drug abuse within 3 months perioperatively;
who had previously received drugs that could have affected the QT
interval or induced/inhibited P450 or CYP2B6 within 2 weeks
perioperatively.
|
Treatment |
Randomly assigned to HSK3486 or propofol dosage
groups in a ratio of 3:1. Drugs were administered as a bolus injection
of 0.4 mg/kg (HSK3486) or 2.0 mg/ kg (propofol) for induction, followed
by maintenance infusion. |
Patients were given midazolam 0.04 mg
kg−1 and sufentanil 0.3 μg kg−1 as preanesthetic medication. Anesthesia
induction was then initiated with either HSK3486 or propofol. After
successful induction, the muscle relaxant rocuronium bromide was
administered at 0.6 mg kg−1, and endotracheal intubation was performed.
HSK3486 or propofol was given at appropriate doses to maintain
anesthesia. Remifentanil was administered at 0.1–0.3 μg/kg−1 min−1 for
analgesia, and sufentanil and a muscle relaxant were added. bromide. |
During anesthesia induction, the ciprofol group was infused at a time
limit of 0.5 mg/kg for one minute, and the propofol group was infused at
a time limit of 2 mg/kg for 1 min. |
Intravenous midazolam (0.03 mg/kg)
and sufentanil (0.3 μg/kg) were used to start general anesthesia
induction, followed 2 min later by the manual injection of ciprofol
(0.4 mg/kg) or medium-and long-chain triglyceride (MCT/LCT) propofol
(2 mg/kg). Patients started receiving preoxygenation after intravenous
midazolam and sufentanil being administrated. When spontaneous breathing
disappeared, it switched to manual controlled breathing. i |
The
patients were randomized into a ciprofol group (group C) and a propofol
group (group P). Anesthesia induction: group C had injected IV with
ciprofol 0.4 mg/kg, group P had injected IV with propofol 2.0 mg/kg,
while both groups had injected IV with sufentanil 0.4-0.5 μg/kg and
cisatracurium 0.2 mg/kg. Anesthesia maintenance: ciprofol was injected
IV with 0.8-2.4 mg•kg-1•h-1 in group C, propofol was injected IV with
4-12 mg•kg-1•h-1 in group P, while remifentanil was injected IV with
8-15 μg•kg-1 •h-1 and cisatracurium was injected IV with
0.1-0.2mg•kg-1•h-1, with the bispectral index |
Optimal injected doses
of 0.4 mg/kg of ciprofol and 2.0 mg/kg of propofol |
Primary efficacy outcome |
The success rate of anesthesia
maintenance. |
Noninferiority between the drugs was evaluated as the
lower limit of the 95% confidence interval (CI) for the group
difference. |
(1) bradycardia (HR < 50 beats/min,
> 30s); (2) Tachycardia (HR > 100 beats/min,
> 30s) (3) Hypotension (30% reduction in SBP compared to
baseline value); (4) Hypertension (SBP is 20% higher than baseline
value); (5) injection pain at the site. (6) Intraoperative body
movements |
Safety and efficacy of ciprofol. Evaluation The success rate
of general anesthesia induction was the primary outcome for the present
study. |
The success rate of sedation. |
The anesthesia induction
success. |
Secondary Efficacy outcome
|
Times from discontinuation of HSK3486 or propofol maintenance to full
alertness, respiratory recovery, extubation and reaching the goal of the
Aldrete score.
|
Successful anesthetic induction, full alertness and spontaneous
breathing recovery, time until leaving the postanesthetic care.
|
(1) success rate of induction of anesthesia, (2) the time of loss of
consciousness (time of initiation of study drug infusion to MOAA/S ≤ 1),
(3) time of awakening (time of drug discontinuation to extubation), (4)
study drug top-up doses, (5) rescue drug use.
|
(1) the time to onset of successful induction; (2) the incidence of
injection site pain as detected by a withdrawal response or a numeric
rating. (3) time to eyelash reflex disappearance. (4) changes in the
bispectral index (BIS) during the 10-min interval.
|
. HR showed no significant difference between the two groups
(p>0.05). MAP decreased more significantly in group P at T6
(p0.05)
|
The average time to successful anesthesia and loss of the eyelash
reflex.
The pattern of BIS changes.
The incidence of injection pain/
|
Follow up |
N/A |
N/A |
N/A |
N/A |
N/A |
N/A |