Comparison of intraoperative hemodynamic parameters between propofol- and remimazolam-based total intravenous anesthesia in patients undergoing robotic gynecologic surgery: a randomized controlled trial protocol
This trial is expected to provide prospective, randomized evidence to compare continuous intraoperative blood-pressure trajectories between remimazolam- and propofol-based TIVA during robotic gynecologic surgery and clarify the relative hemodynamic stability of these anesthetic agents under the combined physiological challenges of Trendelenburg positioning and pneumoperitoneum.
Abstract
Introduction Propofol-based total intravenous anesthesia (TIVA) with remifentanil is widely used for general anesthesia but is frequently associated with hypotension and bradycardia. Remimazolam, an ultra–short-acting benzodiazepine, provides rapid onset and offset, with the additional advantage of reversal by flumazenil, and may result in less hemodynamic depression. Previous randomized studies have largely focused on the induction phase or the incidence of hypotension, with limited data on continuous intraoperative hemodynamic changes during laparoscopic gynecologic surgery. The study is designed to compare prospectively the intraoperative hemodynamic profiles of remimazolam-based versus propofol-based TIVA in patients undergoing robotic gynecologic surgery in the Trendelenburg position. Methods and Analysis This prospective, single-center, randomized, single-blind, parallel-group superiority trial will be conducted at CHA Ilsan Medical Center, a secondary care university-affiliated hospital. In total, 58 adult patients (aged 19–65 years, American Society of Anesthesiologists physical status I–II) scheduled for elective robotic laparoscopic hysterectomy under general anesthesia will be enrolled and randomly assigned (1:1) to receive either remimazolam- or propofol-based total intravenous anesthesia, both in combination with remifentanil. Continuous invasive mean arterial pressure (MAP) will be monitored using a FloTrac™ sensor (Edwards Lifesciences, Irvine, CA, United States). The primary outcome will be the time-weighted average MAP (TWA-MAP), analyzed using analysis of covariance adjusted for baseline MAP. Secondary outcomes will include the area under the curve for hypertensive and hypotensive burden, as well as the incidence of adverse hemodynamic events, including hypotension, hypertension, bradycardia, and tachycardia. Generalized estimating equations (GEE) will be used to evaluate hemodynamic and respiratory parameters across predefined time points. Discussion This trial is expected to provide prospective, randomized evidence to compare continuous intraoperative blood-pressure trajectories between remimazolam- and propofol-based TIVA during robotic gynecologic surgery. It is anticipated that the findings will clarify the relative hemodynamic stability of these anesthetic agents under the combined physiological challenges of Trendelenburg positioning and pneumoperitoneum. The findings may inform anesthetic drug selection and intraoperative blood pressure management strategies, enhancing cardiovascular stability and improving postoperative outcomes. Clinical Trial Registration ClinicalTrials.gov, identifier NCT07251101.
Background:Functional Endoscopic Sinus Surgery (FESS) requires a clear and bloodless surgical field for optimal visualization and prevention of intraoperative complications. Controlled hypotension is commonly employed during FESS to reduce blood loss and improve surgical conditions. Dexmedetomidine and Propofol are widely used agents for controlled hypotensive anesthesia. The present study was conducted to compare the efficacy of dexmedetomidine and propofol infusion in achieving controlled hypotension during FESS.Methodology:This prospective randomized comparative study was conducted in the Department of Anaesthesiology at Sree Mookambika Institute of Medical Sciences from June 2025 to March 2026. A total of 100 patients aged between 18 and 40 years belonging to ASA Grade I and II undergoing elective FESS were included in the study. Patients were randomly allocated into two groups of 50 each. Group D received dexmedetomidine infusion at 0.4–0.8 μg/kg/hr, while Group P received propofol infusion at 75–100 μg/kg/min following induction of general anesthesia. Intraoperative pulse rate, mean arterial pressure, blood loss, quality of surgical field, sedation score, and complications were assessed and compared between the two groupsResults:Baseline demographic and hemodynamic parameters were comparable between the groups. Intraoperative pulse rate and mean arterial pressure were significantly lower in the dexmedetomidine group at various time intervals compared with the propofol group (p<0.05). Quality of surgical field and mean blood loss were comparable in both groups. Postoperative Ramsay sedation scores at 30 minutes were significantly higher in the propofol group (p=0.023). No major complications were observed in either group.Conclusion:Both dexmedetomidine and propofol were effective and safe agents for controlled hypotension during FESS. Dexmedetomidine provided superior intraoperative hemodynamic stability with comparable surgical field quality and blood loss, making it a useful alternative to propofol for hypotensive anesthesia in endoscopic sinus surgery.
Dr. Balakrishnan, Dr. Subhasan JV· Asian Journal of Medical Res...· 0 citations
Opioid-free total intravenous anesthesia or opioid-free inhalational anesthesia with sevoflurane provide effective and safe anesthesia for bariatric surgery, with comparable pain control and opioid-sparing effects.
Paweł Maciejewski, Tomasz Składzień, Michał Cicio et al.· Obesity Surgery· 0 citations
Background We compared benefits and adverse effects of anesthesia induction with ciprofol, propofol, and etomidate in elderly patients undergoing gastrointestinal endoscopy anesthesia. Methods A total of 391 patients who underwent painless gastrointestinal endoscopy; age ≥ 60 years; ASA I-III were involved between April 30 and 30 December 2025. The primary outcome was hypoxemia or apnea during anesthesia. Secondary outcomes included systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR), respiratory rate (RR), SpO2 during surgery, and adverse reactions such as coughing dizziness and agitation. Results No differences were found in hypoxemia and apnea. Except for RR, other hemodynamic and respiratory parameters were significantly different among the groups (p < 0.05), and the degree of blood pressure decline in group E was smaller than groups C and P. Group E patients had lower intraoperative hypotension (p = 0.007) and lower demand for vasoactive drugs (p = 0.006). The injection pain scores in groups C and E were lower, but patients in group E had a higher incidence of myoclonus, and the proportion of coughing and hiccups during endoscopy was higher in group E. The incidence of dizziness was lower in Group C. Conclusion No significant differences were observed in the incidence of hypoxemia and apnea among three groups. Etomidate has the advantage of stable hemodynamics; however, the incidence of myoclonus, bucking, and hiccups is high. Injection pain occurred less frequently with ciprofol and etomidate, while ciprofol was associated with a low incidence of postoperative dizziness. Clinical Trail Registration https://www.chictr.org.cn/showproj.html?proj=269837, identifier ChiCTR2500101280.
Yingchao Guan, Gang Zhou, Conghui Wang et al.· Frontiers in Aging· 0 citations
Pediatric magnetic resonance imaging (MRI) requires deep sedation to ensure immobility and optimal image quality. Propofol-based total intravenous anesthesia is effective but may cause airway depression and hemodynamic instability at higher doses. Dexmedetomidine has minimal respiratory effects but may prolong sedation. This study evaluated whether a low-dose dexmedetomidine bolus combined with propofol shortens recovery time (primary outcome); improves hemodynamic stability; reduces airway events, induction time, and total propofol dose; and minimizes scan interruptions (secondary outcomes).
In this prospective, randomized controlled trial, children undergoing MRI were assigned to two groups. Group D+P received 0.5 μg/kg of dexmedetomidine over 2–3 minutes plus a 1 mg/kg bolus of propofol followed by infusion; Group P received propofol alone as bolus and infusion. Propofol infusion rate was adjusted to achieve a Ramsay Sedation Scale score of 5–6. Recovery time was analyzed using
t
test; scan interruptions were compared using Chi-square or Fisher’s exact tests.
Group D+P had a shorter recovery time (19.4 ± 35 vs. 31.4 ± 36.1 min;
P
= 0.042) and faster induction (128.9 vs. 224.6 sec;
P
< 0.001). The propofol infusion rate was lower in Group D + P than in Group P (76.3 ± 65.6 vs 123 ± 45.5 μg/kg/min;
P
< 0.001). Additional boluses were more frequent in Group P (
P
= 0.003). Bradycardia occurred in significantly more children in Group D + P than in Group P (
P
= 0.008).
Low-dose dexmedetomidine as an adjunct to propofol for pediatric MRI sedation reduces recovery time, propofol requirement, and airway-related complications, while enabling faster induction and fewer scan interruptions with increased risk of bradycardia.
Kishorkumar Dhanaboopathy, E. Rai, Aparna Williams et al.· Journal of Anaesthesiology C...· 0 citations
Background The induction of general anesthesia with propofol often results in hypotension, primarily attributed to decreased cardiac index (CIx) among elderly patients. Norepinephrine (NE) is typically used to manage anesthesia-induced hypotension. We hypothesized that NE attenuates the reduction in CIx while preserving blood pressure. Methods In a randomized, double-blinded trial, 60 elderly patients undergoing elective major abdominal surgery were randomly allocated to receive NE (6 µg/ml) (NE group) or saline (control [CT] group) during induction. CIx was monitored using the FloTrac/Vigileo system, and the primary outcome was the change in CIx (△CIx) (△Value = value measured at the study time point–baseline value) at 10 min post-intubation (T10). Changes in systemic vascular resistance index (△SVRI) and mean arterial pressure (△MAP) were also evaluated for comparison. Results In NE group, CIx decreased from 3.9 to 2.9 L/min/m2 at 10 min post-intubation (T10), whereas in CT group, it declined from 3.7 to 2.6 L/min/m2. After adjusting for propofol dosage per weight, the decreases in △CIx (β = 0.63, 95% confidence interval [CI] 0.18 to 1.07; P = 0.006) and △MAP (β = 11.99, 95% CI 2.05 to 21.94; P = 0.018) at T10 were significantly less in NE group compared to CT group, whereas △SVRI did not show a significant difference between the two groups. Conclusions Prophylactic infusion of NE effectively attenuated the decrease in △CIx during propofol-induced anesthesia in elderly patients while maintaining MAP.
Wenping Peng, Xiaolu Sun, Shuang Zhao et al.· Anesthesia and Pain Medicine· 0 citations
Remimazolam, a new member of the benzodiazepine class, has been used as an alternative to propofol during anesthesia induction. In this study, we aimed to examine the effectiveness and safety of remimazolam compared with propofol for both the induction and maintenance of fast-track general anesthesia in children undergoing percutaneous closure of an atrial septal defect (ASD). We carried out a single-center, prospective, randomized controlled, observer-blinded, non-inferiority trial among 101 children, of whom 57 received remimazolam and 44 received propofol. All children underwent percutaneous closure of an atrial septal defect and had an American Society of Anesthesiologists (ASA) physical status of II before surgery. The primary outcome was the time to laryngeal mask airway (LMA) removal, measured in minutes. We included all 101 patients in the final analysis. Children in the remimazolam group had a significantly shorter time to LMA removal (mean difference [MD]: ‑7.97 min; 95% CI: ‑8.91 to ‑7.02; p < 0.001) and a shorter duration of hospitalization (median 5 vs. 7 days; p < 0.001) than the propofol group. The Pediatric Anesthesia Emergence Delirium (PAED) score was also lower in the remimazolam group (median 3 vs. 6; p < 0.001), indicating a reduced occurrence of postoperative emergence delirium. Fewer children in the remimazolam group required a vasopressor (26% vs. 64%). Mean arterial pressure and heart rate each showed a significant intervention-by-time interaction (their trajectories over time differed between groups), without a significant overall between-group difference in either. This study suggests that remimazolam offers advantages over propofol for fast-track anesthesia in children undergoing percutaneous ASD closure, including faster LMA removal, shorter hospitalization, and a lower incidence of postoperative emergence delirium, with a differing intraoperative mean arterial pressure trajectory and comparable overall hemodynamic stability. ChiCTR2500109737, Registration date: 24 Sep. 2025. Retrospectively registered.
