Evidence map›Paper›PMID 35157236›Full record

Trial reportCNS drugs2022

Efficacy and Safety of HSK3486 for Anesthesia/Sedation in Patients Undergoing Fiberoptic Bronchoscopy: A Multicenter, Double-Blind, Propofol-Controlled, Randomized, Phase 3 Study.

Zhen Luo, Hong Tu, Xiang Zhang, Xiao Wang, Wen Ouyang, Xinchuan Wei, Xiaohua Zou, Zhaoqiong Zhu, Yalan Li, Wangning Shangguan and 3 more

4 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in CNS drugs, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 61 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 3 pooled it
20.5field-weighted citation impact, top 1% 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.

NCT04111159 phase3completednot on this map

A Multi-Center, Randomized, Double-Blind, Propofol-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion for the Induction of Sedation/Anesthesia in Subjects Undergoing Fiberoptic Bronchoscopy

TypeinterventionalSponsorSichuan Haisco Pharmaceutical Group Co., LtdRan2019 to 2020Enrolled267ConditionsSedation or AnesthesiaArmsHSK3486, Propofol
NCT05843383 naunknown statusnot on this mapstarted 2023, after this paper: background citation

Comparison of Ciprofol-based and Propofol-based Total Intravenous Anesthesia on Postoperative Quality of Recovery in Elderly Patients Undergoing Laparoscopic Surgery

TypeinterventionalSponsorXijing HospitalRan2023 to 2024Enrolled280ConditionsAnesthetics, Intravenous, Postoperative Complications, Hypnotics and Sedatives, Postoperative RecoveryArmsCiprofol, Propofol
NCT06344949 phase4completednot on this mapstarted 2024, after this paper: background citation

Ciprofol Versus Propofol for Tracheal Intubation in ICU Patients: a Randomized Controlled Pilot Study

TypeinterventionalSponsorShanghai Zhongshan HospitalRan2024 to 2025Enrolled100ConditionsEmergency Tracheal Intubation in Critically Ill PatientsArmsCiprofol, Propofol
NCT07028593 phase4recruitingnot on this mapstarted 2025, after this paper: background citation

Effects of Ciprofol on Myocardial Injury After Non-cardiac Surgery (CP-MINS) in Patients Undergoing Video-Assisted Thoracoscopic Surgery: A Randomized, Double-Blind, Propofol-Controlled, Multicenter Trial

TypeinterventionalSponsorTongji HospitalRan2025 to 2027Enrolled1,058ConditionsMyocardial Injury, Thoracic Diseases, Thoracoscopic SurgeryArmsPropofol, ciprofol
3 · Its place in the literature

Who cites it

61 citing papers in PubMed, 3 syntheses or guidelines pooled it, 88 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

1 more citing papers are in PubMed but not listed here.

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

13 authors at 9 institutions in 1 country.

Zhen Luo *Department of Anesthesiology, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Chengdu, 610041, Sichuan, China.
Hong Tu *Department of Anesthesiology, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Chengdu, 610041, Sichuan, China.
Xiang ZhangDepartment of Anesthesiology, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Chengdu, 610041, Sichuan, China.
Xiao WangDepartment of Anesthesiology, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Chengdu, 610041, Sichuan, China. 1490829116@qq.com.
Wen OuyangDepartment of Anesthesiology, The Third Xiangya Hospital of Central South University, Changsha, China.
Xinchuan WeiDepartment of Anesthesiology, Sichuan Provincial People's Hospital, Chengdu, China.
Xiaohua ZouDepartment of Anesthesiology, The Affiliated Hospital of Guizhou Medical University, Guiyang, China.
Zhaoqiong ZhuDepartment of Anesthesiology, Affiliated Hospital of Zunyi Medical University, Zunyi, China.
Yalan LiDepartment of Anesthesiology, The First Affiliated Hospital of Jinan University, Guangzhou, China.
Wangning ShangguanDepartment of Anesthesiology, The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China.
Hui WuDepartment of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
Yaping WangDepartment of Anesthesiology, The Second Xiangya Hospital of Central South University, Changsha, China.
Qulian GuoDepartment of Anesthesiology, Xiangya Hospital Central South University, Changsha, China.
Sichuan University · CNAffiliated Hospital of Guizhou Medical University · CNCentral South University · CNFirst Affiliated Hospital of Jinan University · CNFirst Affiliated Hospital of Wenzhou Medical University · CNSecond Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University · CNSecond Xiangya Hospital of Central South University · CNXiangya Hospital Central South University · CNZunyi Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFiberoptic bronchoscopy is a complex procedure with the need for sufficient patient anesthesia/sedation while maintaining safety. This trial aimed to evaluate the efficacy, safety, and pharmacokinetics of HSK3486 during fiberoptic bronchoscopy.

methodsThis multicenter, double-blind, randomized, non-inferiority, parallel-group phase 3 trial was conducted in patients who underwent fiberoptic bronchoscopy. Patients randomly received HSK3486 0.4 mg/kg (N = 134) or propofol 2.0 mg/kg (N = 133). The primary efficacy endpoint was the successful rate of fiberoptic bronchoscopy, and secondary efficacy endpoints included successful induction of anesthesia/sedation, duration, time to being fully alert, and time to patient discharge. Safety assessments and drug concentrations were also measured.

resultsA total of 267 patients completed fiberoptic bronchoscopy, with a success rate of 100% and a 95% confidence interval of - 2.8 to 2.8% for the difference between the groups, which met the predesigned criteria of > - 8%, confirming the non-inferiority of anesthesia/sedation produced by HSK3486 compared to propofol. Among the secondary efficacy endpoints, only time to full alertness (median 8.50 vs. 6.00 min, P = 0.012) and time to discharge (median 13.00 vs. 9.87 min, P = 0.002) were slightly longer in the HSK3486 group. The incidence of adverse events was significant lower in the HSK3486 group (52.6 vs. 76.5%, P < 0.001) mainly because of less pain on injection (4.4 vs. 39.4%, P < 0.001) compared to the propofol group. HSK3486 had a similar terminal elimination half-life as propofol.

conclusionsHSK3486 exhibited non-inferiority anesthesia/sedation compared to propofol in patients undergoing fiberoptic bronchoscopy, and had a good safety profile with a lower incidence of pain on injection.

trial registrationClinicaltrials.gov, NCT04111159, registered on 1 October 2019.

Indexed as

AnesthesiaPropofolBronchoscopyDouble-Blind MethodHumansHypnotics and SedativesPainHypnotics and SedativesPropofol

Identifiers

PMID35157236
PMCPMC8927014
OpenAlexW4212788764

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.