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Effects of ciprofol infusion on hemodynamics during induction and maintenance of anesthesia and on postoperative recovery in patients undergoing thoracoscopic lobectomy: Study protocol for a randomized, controlled trial.

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  • Additional Information
    • Source:
      Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE
    • Publication Information:
      Original Publication: San Francisco, CA : Public Library of Science
    • Subject Terms:
      Hemodynamics*/drug effects; Adolescent ; Adult ; Aged ; Female ; Humans ; Male ; Middle Aged ; Young Adult ; Anesthesia Recovery Period ; Anesthesia, General/methods ; Pneumonectomy/adverse effects ; Pneumonectomy/methods ; Propofol/administration & dosage ; Thoracoscopy/methods
    • Abstract:
      Introduction: Ciprofol, a new candidate drug, is effective and safe for the maintenance of anesthesia in non-cardiothoracic and non-neurological elective surgery. However, few studies have been conducted on general anesthesia using ciprofol in patients undergoing thoracoscopic lobectomy. Therefore, this study aims to observe the effects of ciprofol on hemodynamics and on postoperative recovery in patients undergoing thoracoscopic lobectomy.
      Methods and Analysis: This randomized controlled trial will include 136 patients aged 18-65 years undergoing elective thoracoscopic lobectomy between April 2023 and December 2024. The participants will be randomly assigned to the propofol or ciprofol group. The primary outcome to be assessed is the hemodynamic fluctuation during the induction and maintenance of anesthesia. The secondary outcomes involve quality of anesthesia induction and quality of recovery from anesthesia. The former includes TLOC (time to loss of consciousness), the use of vasoactive agents, the incidence of injection pain, body movement, muscle twitching and coughing during induction of anesthesia. The latter includes TROC (time to recovery of consciousness), post anesthesia care unit (PACU) time, incidence of postoperative nausea and vomiting (PONV), postoperative agitation, intraoperative awareness and quality of recovery (QoR) score.
      Discussion: A number of clinical trials have confirmed that ciprofol, as a new sedative-hypnotic agent, has advantages of better tolerance, higher sedation satisfaction score, and lower incidence of adverse reactions, especially in reducing the incidence of injection pain. But considering that ciprofol was recently developed, limited data are available regarding its use for general anesthesia. This study aims to investigate the effects of ciprofol on hemodynamics and on postoperative recovery of patients undergoing thoracoscopic lobectomy. The results of this study may provide evidence for the safe application of ciprofol, a new choice of general anesthetic for thoracic surgery.
      Clinical Trial Registration: ClinicalTrials.gov (NCT05664386).
      Competing Interests: The authors have declared that no competing interests exist.
      (Copyright: © 2024 Guo et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
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    • Molecular Sequence:
      ClinicalTrials.gov NCT05664386
    • Accession Number:
      YI7VU623SF (Propofol)
    • Publication Date:
      Date Created: 20240710 Date Completed: 20240710 Latest Revision: 20240831
    • Publication Date:
      20250114
    • Accession Number:
      PMC11236111
    • Accession Number:
      10.1371/journal.pone.0305478
    • Accession Number:
      38985796