Evidence map›Paper›PMID 34417990›Full record

ArticleAdvances in therapy2021

Efficacy and Safety of Ciprofol Sedation in ICU Patients with Mechanical Ventilation: A Clinical Trial Study Protocol.

Yongjun Liu, Chuanxi Chen, Ning Liu, Li Tong, Yao Nie, Jianfeng Wu, Xiao Liu, Wei Gao, Lei Tang, Xiangdong Guan

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Advances in therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
6.1field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04620031 phase3completednot on this map

A Multi-Center, Randomized, Single-Blind, Propofol-Controlled Phase III Clinical Study Evaluating Sedation of Intravenous Administration of HSK3486 Injectable Emulsion in ICU Patients Undergoing Mechanical Ventilation

TypeinterventionalSponsorHaisco Pharmaceutical Group Co., Ltd.Ran2020 to 2021Enrolled135ConditionsSedation in Intensive CareArmsHSK3486, Propofol
NCT06015074 naunknown statusnot on this mapstarted 2024, after this paper: background citation

Ciprofol vs Propofol for Reducing Hypoxia Incidence in Intravenous Anesthesia During Elective Endoscopic Retrograde Cholangiopancreatography-A Randomized Double Blinded Controlled Trial.

TypeinterventionalSponsorRenJi HospitalRan2024 to 2025Enrolled136ConditionsAnesthesia, Adverse Effect, Biliary Tract DiseasesArmsPropofol, Ciprofol
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 30 citations in OpenAlex.

  1. Trial
  2. Comparison of Ciprofol-Nalbuphine and Propofol-Nalbuphine Sedation During Painless Gastrointestinal Endoscopy: A Randomized Controlled Trial.Medical science monitor : international medical journal of experimental and clinical research · 2026
    Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 1 country.

Yongjun LiuDepartment of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen University, No. 58 Zhongshan 2nd Rd, Guangzhou, 510080, Guangdong, China.
Chuanxi ChenDepartment of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen University, No. 58 Zhongshan 2nd Rd, Guangzhou, 510080, Guangdong, China.
Ning LiuDepartment of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen University, No. 58 Zhongshan 2nd Rd, Guangzhou, 510080, Guangdong, China.
Li TongDepartment of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen University, No. 58 Zhongshan 2nd Rd, Guangzhou, 510080, Guangdong, China.
Yao NieDepartment of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen University, No. 58 Zhongshan 2nd Rd, Guangzhou, 510080, Guangdong, China.
Jianfeng WuDepartment of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen University, No. 58 Zhongshan 2nd Rd, Guangzhou, 510080, Guangdong, China.
Xiao LiuDepartment of Medical, Haisco Pharmaceutical Group Co., Ltd, Shanghai, China.
Wei GaoDepartment of Medical, Haisco Pharmaceutical Group Co., Ltd, Shanghai, China.
Lei TangDepartment of Good Clinical Practice, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.
Xiangdong GuanDepartment of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen University, No. 58 Zhongshan 2nd Rd, Guangzhou, 510080, Guangdong, China. guanxd@mail.sysu.edu.cn.
The First Affiliated Hospital, Sun Yat-sen University · CNSun Yat-sen University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionFrom previous studies of pharmacodynamic data in mice, rats, beagle dogs and mini pigs, frequently in direct comparison to induction doses of propofol, ciprofol produced a rapid onset of anesthesia/sedation.

methodsA phase 1 study suggested potential clinical advantages of ciprofol as a sedation/anesthetic agent, with no evidence of drug-related toxicity. However, the sedation effects and safety of ciprofol in intensive care unit (ICU) patients with mechanical ventilation should be further confirmed in a phase 3 study with a larger cohort of patients. During a phase 3, non-inferiority, multicenter, single-blind, randomized, propofol controlled trial, Chinese ICU patients undergoing mechanical ventilation and requiring endotracheal intubation will be sedated for 6-24 h after randomization. Considering a success rate for ICU sedation of 99% for ciprofol and the positive control drug propofol, a total sample size of 120 subjects with mechanical ventilation will be required to achieve 80% power to determine non-inferiority with a margin of 8%. Finally, taking into account 10% losses, 135 patients will be enrolled and randomly assigned to ciprofol (90 cases) and propofol (45 cases) groups in a 2:1 ratio. The primary outcome will be the success rate of sedation satisfied by the following conditions: the time within the range of Richmond Agitation and Sedation Score (+ 1 ~ - 2) must account for ≥ 70% of the study drug administration time and without other rescue treatments. Secondary outcomes will include the average time to reach the sedation goal, study drug usage, rescue medication given per unit weight, extubation time, recovery time to full consciousness and nursing scores. Safety endpoints will include adverse events (AEs), drug related AEs and serious AEs. PLANNED OUTCOMES: The results of this study will provide crucial information on the use of ciprofol for sedation of patients in ICUs.

trial registrationClinicalTrials.gov identifier, NCT04620031.

Indexed as

AnesthesiaRespiration, ArtificialAnimalsClinical Trials, Phase III as TopicDogsEquivalence Trials as TopicHumansIntensive Care UnitsMiceMulticenter Studies as TopicRandomized Controlled Trials as TopicRatsSingle-Blind MethodSwineSwine, MiniatureAnesthesiaCiprofolMechanical ventilationPropofolSedation

Identifiers

PMID34417990
PMCPMC8478731
OpenAlexW3195076223

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.