remimazolam tosylate (HR-7056) / Jiangsu Hengrui Pharma - LARVOL DELTA

Short-term postoperative neurocognitive safety and recovery profiles of remimazolam tosilate combined with flumazenil vs. propofol in cirrhotic patients undergoing endoscopic variceal treatment: a randomized controlled trial. (PubMed, Front Med (Lausanne)) - P=N/A | "Consequently, this regimen represents a neurologically safe (with regard to short-term cognitive outcomes), rapidly controllable, and clinically feasible anesthetic option for this high-risk population. this study was registered on https://www.chictr.org.cn, (ChiCTR2200066161)."

Journal • Anesthesia • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Liver Cirrhosis • Liver Failure

The study on the recovery quality of remimazolam toluenesulfonate when used as a maintenance anesthetic regimen compared with other anesthetic regimens (ChiCTR) - P4 | N=3300 | Not yet recruiting | Sponsor: Shunde Hospital of Guangzhou University of Traditional Chinese Medicine; Shunde Hospital of Guangzhou University of Traditional Chinese Medicine

New P4 trial • Real-world evidence • Anesthesia

A Study Assessing Heart Rate Variability During Anesthesia Induction with Remimazolam Besylate and Remifentanil Coadministration in Elderly Patients. (ChiCTR) - P=N/A | N=152 | Recruiting | Sponsor: The Affiliated Hospital of Guizhou Medical University; The Affiliated Hospital of Guizhou Medical University | Not yet recruiting ➔ Recruiting

Enrollment open • Anesthesia

Application of remimazolam tosylate-based anesthesia in enhanced recovery for liver transplantation (ChiCTR) - P=N/A | N=120 | Completed | Sponsor: Affiliated Hospital of Qingdao University; Affiliated Hospital of Qingdao University | Not yet recruiting ➔ Completed

Trial completion • Anesthesia • Transplantation

A Clinical Study on the Impact of Remimazolam Tosilate for Maintenance of General Anesthesia on Postoperative Recovery Quality (ChiCTR) - P=N/A | N=64 | Not yet recruiting | Sponsor: Min Dong Hospital Affiliated to Fujian Medical University; Min Dong Hospital Affiliated to Fujian Medical University

New trial • Anesthesia

A Comparative Study on Postoperative Recovery Quality Between Remimazolam Tosylate and Propofol in Patients with Hidden Obesity Undergoing General Anesthesia for Unilateral Biportal Endoscopic Surgery (ChiCTR) - P4 | N=50 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Harbin Medical University; The First Affiliated Hospital of Harbin Medical University

New P4 trial • Anesthesia • Genetic Disorders • Obesity

RMZ-OLI-ENDO: Remimazolam Combined With Oliceridine for Sedation in Elderly Patients Undergoing Gastrointestinal Endoscopy (clinicaltrials.gov) - P=N/A | N=240 | Recruiting | Sponsor: Baoshan Branch, Renji Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting ➔ Recruiting

Enrollment open • Anesthesia

Remimazolam vs. propofol anaesthesia for delirium in older patients recovering from lung resections: a randomised non-inferiority trial. (PubMed, Anaesthesia) - "Remimazolam was not non-inferior to propofol for postoperative delirium in older patients having lung resection surgery and provoked more emergence delirium."

Head-to-Head • Journal • Anesthesia • CNS Disorders

Sedation Dose of Remimazolam for Older Adults Undergoing Hip Arthroplasty with Neuraxial Anesthesia and Its Impact on Postoperative Delirium. (PubMed, Neuro Endocrinol Lett) - "Compared with saline, the remimazolam groups had lower cortisol and norepinephrine concentrations at operating room exit, whereas within‑group changes from entry to exit did not reach statistical significance (p > 0.05). Within the observed POD incidence range (2.86-6.00%), remimazolam did not appear to increase POD over the first 7 postoperative days compared with saline, although the study was not powered to detect modest differences."

Journal • Anesthesia • CNS Disorders • Orthopedics

RMZ-OLI-ENDO: Remimazolam Combined With Oliceridine for Sedation in Elderly Patients Undergoing Gastrointestinal Endoscopy (clinicaltrials.gov) - P=N/A | N=240 | Not yet recruiting | Sponsor: Baoshan Branch, Renji Hospital, Shanghai Jiao Tong University School of Medicine

New trial • Anesthesia

Pharmacokinetics, safety, and efficacy of remimazolam tosylate for injection evaluated (clinicaltrials.gov) - P2/3 | N=240 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Completed | Phase classification: P2 ➔ P2/3 | N=138 ➔ 240

Enrollment change • Phase classification • Trial completion • Anesthesia • Pediatrics

Age-Stratified ED9 5 of Remimazolam Tosilate for Moderate Sedation in Pediatric Patients: A Biased Coin Design Study. (PubMed, Drug Des Devel Ther) - P=N/A | "Although remimazolam demonstrated an overall favorable safety profile, individualized dose titration remains essential, particularly given the 17.5% incidence of bradycardia observed in toddlers, which warrants closer monitoring. Chinese Clinical Trial Registry (ChiCTR2300075986)."

Journal • Anesthesia • Cardiovascular • Hypotension • Pediatrics

A Trial of Remimazolam for Intraoperative Sedation in Pediatric and Adolescent Patients (clinicaltrials.gov) - P2/3 | N=249 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Completed

Trial completion • Anesthesia • Pediatrics

Clarifying Baseline Cognitive Eligibility and Cross-Scale Follow-Up in a Randomized Trial of Remimazolam Tosylate for Laparoscopic Surgery [Response To Letter]. (PubMed, Drug Des Devel Ther) - No abstract available

Journal

Application value and safety advantages of remimazolam tosilate in sedation for emergency rescue endotracheal intubation. (PubMed, Am J Transl Res) - "In emergency intubation, compared to propofol, remimazolam tosilate demonstrated a slower onset of sedation but offers better hemodynamic stability, higher first-attempt success rates, more favorable respiratory profiles, and improved early cognitive recovery, making it a valuable alternative sedative."

Intubation • Journal • Anesthesia • CNS Disorders • Depression • Hypotension • Pain • Psychiatry

Efficacy and safety of remimazolam tosylate for sedation in ICU patients: A multicenter, randomized, phase 2 study. (PubMed, J Intensive Med) - P2 | "One serious TEAE (3.4%, disease progression) and one death were reported in HAR group, both were assessed as unrelated to remimazolam tosylate. Remimazolam tosylate demonstrated high efficacy with manageable safety profile for short-term sedation in mechanically ventilated ICU patients at both 0.1 mg/(kg·h) and 0.2 mg/(kg·h) adjustment rates.Trial registration: ClinicalTrials.gov, NCT05152303."

Journal • P2 data • Anesthesia • Cardiovascular • Critical care • Hematological Disorders • Hypertension • Hypotension

Comparative Effects of Remimazolam Tosylate and Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Thoracoscopic Surgery. (clinicaltrials.gov) - P=N/A | N=105 | Completed | Sponsor: First Affiliated Hospital of Kunming Medical University

New trial • CNS Disorders • Geriatric Disorders

Clarifying Baseline Cognitive Eligibility and Cross-Scale Follow-Up in a Randomized Trial of Remimazolam Tosylate for Laparoscopic Surgery [Letter]. (PubMed, Drug Des Devel Ther) - No abstract available

Journal

A retrospective study on the effects of different doses of remimazolam tosylate combined with sevoflurane on postoperative sleep disorders in patients undergoing elective surgeries (ChiCTR) - P=N/A | N=165 | Sponsor: Sun Yat-sen Memorial Hospital of Sun Yat-sen University; Sun Yat-sen Memorial Hospital of Sun Yat-sen University

New trial • CNS Disorders • Sleep Disorder

Comparison of the Safety of Remimazolam Tosilate and Propofol in Non-intubated General Anesthesia for Gastrointestinal Endoscopy Based on Dynamic Trajectories of Vital Signs Monitored by Wearable Devices: A Prospective Randomized Controlled Study (ChiCTR) - P=N/A | N=260 | Sponsor: The Second People's Hospital of Chengdu, Sichuan University; The Second People's Hospital of Chengdu, Sichuan University,

New trial • Anesthesia • Gastroenterology • Gastrointestinal Disorder

A Randomized Controlled Trial: Effects of Remimazolam, Propofol, and Sevoflurane on Postoperative Fatigue after Laparoscopic Gynecological Surgery (ChiCTR) - P=N/A | N=120 | Completed | Sponsor: Baotou Central Hospital; Baotou Central Hospital

New trial • Fatigue • Gynecology

The effect of remimazolam mesylate versus propofol on postoperative fatigue syndrome in patients with laparoscopic colorectal cancer: A randomized controlled trial (ChiCTR) - P=N/A | N=92 | Sponsor: The Affiliated Hospital of Xuzhou Medical University; The Affiliated Hospital of Xuzhou Medical University

New trial • Colorectal Cancer • Fatigue • Oncology • Solid Tumor

Study of the hypnotic effect and pharmacokinetics of remimazolam tosylate in volunteers with different level of obstructive sleep apnoea (ChiCTR) - P=N/A | N=45 | Completed | Sponsor: Eye & ENT Hospital of Fudan University; Eye & ENT Hospital of Fudan University | Not yet recruiting ➔ Completed | Phase classification: P4 ➔ PN/A

Phase classification • Trial completion • Respiratory Diseases • Sleep Apnea • Sleep Disorder

The Effects of Remimazolam Tosylate on Postoperative Memory Function in Young and Middle-Aged Patients Undergoing Laparoscopic Surgery. (PubMed, Drug Des Devel Ther) - "For young and middle-aged patients undergoing laparoscopic surgery, remimazolam reduces the incidence of early postoperative memory decline (within the first three days) and provides superior hemodynamic stability with a milder inflammatory response compared to propofol. However, no significant difference was observed in cognitive function at one month postoperatively, indicating that the benefits are primarily confined to the early recovery period."

Clinical • Journal • Anesthesia • Cardiovascular • Cognitive Disorders • Diabetes • Hypotension • Inflammation • Metabolic Disorders • Movement Disorders • IL6

Dose Recommendation of Remimazolam Tosilate for General Anesthesia in Children and Adolescents: Synergistic Combination of PopPK and PBPK Approaches. (PubMed, Pharmaceutics) - "The model-informed dosing regimens have received regulatory approval from the Center for Drug Evaluation (CDE) in China and are currently being evaluated in an ongoing clinical trial. The integrated PopPK-PBPK approach supports evidence-based dosing recommendations of remimazolam for general anesthesia in children and adolescents aged 3-18 years and provides a reference for dose selection in future clinical studies."

Journal • Anesthesia • Pediatrics