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

• Published in: PloS one 2024-07, Vol.19 (7), p.e0305478
• Main Authors: Guo, Na, Cao, Jianqiao, Duan, Mingjie, Zhou, Fei, Wang, Wei, Xu, Lingling, Wei, Chuansong, Song, Xiumei
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Analysis; Anesthesia; Anesthesia Recovery Period; Anesthesia, General - methods; Blood pressure; Clinical trials; Consciousness; Data recovery; Dosage and administration; Drug dosages; Drug withdrawal; FDA approval; Female; General anesthesia; General anesthetics; Health aspects; Heart rate; Hemodynamics; Hemodynamics - drug effects; Humans; Hypotension; Injection; Intubation; Maintenance; Male; Medical research; Medicine and Health Sciences; Medicine, Experimental; Methods; Middle Aged; Nausea; Ostomy; Pain; Patients; Pharmacology, Experimental; Physiological aspects; Pneumonectomy - adverse effects; Pneumonectomy - methods; Postoperative period; Propofol; Propofol - administration & dosage; Recovery (Medical); Study Protocol; Sufentanil; Surgery; Testing; Thoracic surgery; Thoracoscopy; Thoracoscopy - methods; Thorax; Twitching; Variance analysis; Vasoactive agents; Ventilators; Vomiting; Young Adult
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0305478

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. 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. 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. ClinicalTrials.gov (NCT05664386).