Skip to content

A Randomized Controlled Trial Comparing Remimazolam Besylate with Propofol in Hypertensive Patients Undergoing General Anesthesia

A Randomized Controlled Trial on the Anesthetic Efficacy and Hemodynamic Effects of Remimazolam Besylate in Hypertensive Patients Undergoing Laparoscopic Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117697
Enrollment
Unknown
Registered
2026-01-27
Start date
2024-10-15
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Hypertension

Interventions

Propofol group:During the induction and maintenance phases of general anesthesia, propofol was selected for sedation in the propofol group
the other medications (such as analgesics, muscle relaxants, and emergency rescue drugs, etc.) used in both groups for general anesthesia were kept the same except for the sedative drugs.
Remimazolam group:During the induction and maintenance phases of general anesthesia, the remimazolam group used sarazolam phosphate for sedation
the other medications (such as analgesics, muscle relaxants, and emergency rescue drugs, etc.) administered in both groups were kept the same except for the sedative drugs.

Sponsors

Baotou Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients scheduled for laparoscopic surgery under general anesthesia; 2.According to the American Society of Anesthesiologists (ASA) anesthesia classification, they are at levels II or III; 3.Body Mass Index (BMI) is 18-28 kg/m^2; 4.Patients who meet the diagnostic criteria for primary hypertension [systolic blood pressure >=140 mmHg and/or diastolic blood pressure >= 90 mmHg], are regularly receiving antihypertensive medication and have relatively stable blood pressure; 5.Patients have given informed consent, voluntarily participated in this study, and signed the anesthesia informed consent form and the subject informed consent form.

Exclusion criteria

Exclusion criteria: 1.The subjects explicitly refused to participate in this study; 2.Those who are allergic to or have contraindications to benzodiazepine drugs, opioid drugs, and other investigational drugs; 3.Those whose primary hypertension was not effectively controlled before the surgery (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg); 4.Secondary hypertension patients (such as renal hypertension, endocrine hypertension); 5.Patients with acute respiratory inflammation within 2 weeks and a history of unhealed condition; 6.Those with preoperative significant organ dysfunction (such as cardiac insufficiency, pulmonary insufficiency, liver and kidney dysfunction, etc.); 7.Those with a history of diabetes before the surgery; 8.Those with a history of coronary heart disease before the surgery; 9.Those who have been taking (abusing) psychotropic drugs for a long time or have cognitive dysfunction; 10.Those who have taken hormones or immunosuppressants within 3 months before the surgery; 11.Those who have participated in drug clinical trials within 3 months before the surgery; 12.Those with incomplete clinical examination data; 13.Those considered by the researchers to be unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Mean Arterial Pressure (MAP);Heart rate (HR);Peripheral Oxygen Saturation (SpO2);Bispectral Index of Electroencephalogram (BIS);

Countries

China

Contacts

Public ContactBai Shuancheng

Baotou Central Hospital

mzkbsc@sina.com+86 133 4718 8900

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 25, 2026