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Efficacy and safety of remimazolam besylate combined with alfentanil for the induction and maintenance of general anesthesia in obese patients

Efficacy and safety of remimazolam besylate combined with alfentanil for the induction and maintenance of general anesthesia in obese patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104019
Enrollment
Unknown
Registered
2025-06-10
Start date
2025-06-30
Completion date
Unknown
Last updated
2025-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese patients

Interventions

Reimazolam group:Anesthesia induction: Reimazolam besylate was infused at an infusion rate of 12 mg/kg/h, and the patients level of consciousness was assessed using the modified observer alertness/sed
Propofol group:Anesthesia induction: Slow bolus injection of propofol 2-2.5mg/kg. Anesthesia maintenance: Propofol is administered at a rate of 4-12mg/kg/h and adjusted appropriately according to the

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective general anesthesia surgery; 2. Age 18-65 years old, gender is not limited; 3. American Society of Anesthesiologists ASAI.-III. 4. Body mass index BMI >=30 kg/m^2; 5. Non-emergency surgery with an estimated operation time of less than 5 h; 6. Patients voluntarily participate in the trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Subject unequivocally refuses to participate in this study; 2. Those who have contraindications to deep sedation/general anesthesia or have a history of sedation/anesthesia accidents in the past; 3. Those who are known to be allergic to eggs, soy products, opioids and their antidotes, propofol, remimazolam besylate, etc.; Propofol, benzodiazepines, opioids and contraindications to their antidotes; 4. History of having severe liver, kidney, digestive system, hematologic, neuromuscular system, or metabolic system, which in the judgment of the investigator may increase the risk of sedation/anesthesia, and is not suitable for participation in the study; 5. Long-term use of analgesics, psychotropic drugs (including opioids, NSAIDs, sedatives, antidepressants), alcohol abuse for chronic pain, and suspected abuse of narcotic analgesics or sedatives; 6. The following respiratory management risks were identified during the screening period: (1) History of asthma, stridor; (2) Sleep apnea syndrome; (3) Have a history or family history of malignant hyperthermia; (4) Those who have failed tracheal intubation; (5) History of acute inflammation of the respiratory tract within 2 weeks with no cure; (6) suffer from esophageal reflux; (7) Difficulty in airway or difficulty in endotracheal intubation as judged by the investigator at screening (modified Marhalanobis score grade IV.); 7. Those who have participated in any drug clinical trials within 1 month prior to screening; Patients with opioid and sedative/anesthetic use 3 days prior to consultation; 8. Pregnant or parturient; 9. ECG Tips: Heart rate<50 beats/min; 10. Have taken monoamine oxidase inhibitory drugs or antidepressants within 15 days; 11. Subjects who, in the opinion of the investigator, have any other factors that are not suitable for participating in this clinical study.

Design outcomes

Primary

MeasureTime frame
Incidence of adverse events during induction;

Secondary

MeasureTime frame
Extubation time;loss of consciousness time;Hemodynamics;

Countries

China

Contacts

Public ContactZhongyu Wang

The First Affiliated Hospital of Zhengzhou University

wzy781217@168.com+86 139 3716 5514

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026