None listed
Conditions
Brief summary
The primary objective of our study is to examine the efficacy and safety of remimazolam compared to propofol in maintaining the airway through laryngeal mask insertion (LMA) without the use of muscle relaxants. The purpose of this research is to assess the clinical efficacy and safety of remimazolam as an alternative to propofol for anesthesia induction without the use of muscle relaxants during laryngeal mask insertion (LMA) in patients undergoing breast cancer surgery. Additionally, the study will investigate whether remimazolam can provide adequate suppression of airway reflexes, better hemodynamic stability, and a lower incidence of respiratory complications compared to propofol, as well as determine if there are differences in the stress-reducing effects between the two drugs. Research Hypothesis: The use of remimazolam without muscle relaxants enables safe and effective laryngeal mask insertion (LMA) during breast cancer surgery.
Interventions
The study will include sixty consecutive patients undergoing elective breast cancer surgery under general anesthesia, in cases where the airway can be managed using a laryngeal mask airway (LMA).
Prior to induction, standard monitoring (non-invasive blood pressure, pulse oximetry, ECG) and additional BIS (bispectral index) monitoring will be established. A preoperative blood sample will be taken to measure neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), C-reactive prot
The study will include sixty consecutive patients undergoing elective breast cancer surgery under general anesthesia, in cases where the airway can be managed using a laryngeal mask airway (LMA). Prior to induction, standard monitoring (non-invasive blood pressure, pulse oximetry, ECG) and additional BIS (bispectral index) monitoring will be established. A preoperative blood sample will be taken to measure neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), C-reactive protein (CRP), and glucose (GUK). In the intervention group, anesthesia will be induced with remimazolam 0.25 mg/kg IV and sufentanil 0.3 mcg/kg IV, followed by continuous infusion of remimazolam at 1–2 mg/kg/h, adjusted according to BIS values. The target BIS range will be 40–60. BIS values will be recorded every 5 minutes throughout the procedure. The time to loss of the ciliary reflex and the time until BIS drops below 60 will also be recorded. After LMA placement, insertion conditions will be assessed using a three-point scale based on six variables, and the number of insertion attempts will be documented. If deepening of anesthesia is required, patients will receive an additional dose of either 0.5 mg/kg IV propofol or 0.1 mg/kg IV remimazolam. After surgery, the continuous infusion of anesthetics will be stopped, and the time to spontaneous recovery—defined as BIS > 80—will be monitored every minute. A second blood sample will be collected 4 to 6 hours after the beginning of surgery to repeat the same laboratory analyses (NLR, PLR, CRP, and GUK).
Sponsors
University Hospital Center Sestre milosrdnice
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Elective surgical procedure for breast cancer under general anesthesia, where airway management can be secured using a laryngeal mask, with ASA status I, II, and III. Age 18 years and over.
Exclusion criteria
Exclusion criteria include age under 18 years, allergy to any of the used medications, morbid obesity (body mass index >40), active smokers, patients with psychiatric diagnoses or chronic benzodiazepine use, and patients who refuse to participate in the study.
Outcome results
None listed