IntroductionThe adverse effects of general anaesthetic drugs (especially opioids) cannot be ignored. However, current nociceptive-monitoring techniques still lack consistency in guiding the use of opioids. This trial will study the demand for opioid use and patient prognosis in qCON and qNOX-guided general anaesthesia management.Methods and analysisThis prospective, randomised, controlled trial will randomly recruit 124 patients undergoing general anaesthesia for non-cardiac surgery in equal numbers to either the qCON or BIS group. The qCON group will adjust intraoperative propofol and remifentanil dosage according to qCON and qNOX values, while the BIS group will adjust according to BIS values and haemodynamic fluctuations. The differences between the two groups will be observed in remifentanil dosing and prognosis. The primary outcome will be intraoperative remifentanil use. Secondary outcomes will include propofol consumption; the predictive ability of BIS, qCON and qNOX on conscious responses, noxious stimulus and body movements; and changes in cognitive function at 90 days postoperatively.Ethics and disseminationThis study involves human participants and was approved by the Ethics Committee of the Tianjin Medical University General Hospital (IRB2022-YX-075-01). Participants gave informed consent to participate in the study before taking part. The study results will be published in peer-reviewed journals and presented at relevant academic conferences.Trial registration numberChiCTR2200059877
Background: During procedures that are not performed under general anesthesia, elderly patients often have adverse emotions such as nervousness and anxiety due to their consciousness. Sedation is frequently used to relieve these symptoms. However, the adverse effects from currently prescribed sedative drugs such as midazolam, dexmedetomidine, and propofol are common and unavoidable. There has been limited research on the use of remimazolam besylate, a new sedative drug, to determine the effectiveness of the medication in reducing perioperative cognitive dysfunction in elderly patients undergoing non-general anesthesia procedures and to assess the efficacy of the medication in reducing sedation. Methods: This prospective, multicenter, randomized, single-blind, placebo-controlled trial was conducted from July 2021 to February 2022. The study included 330 elderly patients aged > 65 years who underwent non-general anesthesia procedures. Patients were randomly assigned (2:1) to two groups: the remimazolam besylate group and control group. Outcomes:The primary outcomes included sedation levels achieved at target doses and changes in perioperative cognitive function. Additionally, time to awakening, the incidence of postoperative delirium, change in anxiety level, change in sleep rhythm, and the incidence of adverse events during sedation were measured as secondary outcomes.
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