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Efficacy and safety of diazepam on intraoperative blood pressure stabilization in hypertensive patients undergoing vitrectomy under nerve block anesthesia

Efficacy and safety of diazepam on intraoperative blood pressure stabilization in hypertensive patients undergoing vitrectomy under nerve block anesthesia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041772
Enrollment
Unknown
Registered
2021-01-05
Start date
2021-08-01
Completion date
Unknown
Last updated
2021-09-20

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

Conditions

Hypertensive patients with well-controlled BP who need vitrectomy

Interventions

Control group:Take starch tablet orally 60min before operation
Experimental group:Oral diazepam 60min before operation

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1) =18 years old, no history of operations; 2) have a clear history of arterial hypertension, and the BP of these patients can be well controlled In the last 6 months by oral administration of a single calcium channel blockers (CCB); 3) the patient is determined to require vitrectomy under nerve block anaesthesia based on relevant examinations including slit lamp, fundus photography, ocular B ultrasound, optical coherence tomography, fundus fluorescein angiography, indocyanine green angiography combined with a clinical diagnosis of rhegmatogenous retinal detachment, epimacular membrane, macular hole; 4) there is no history of diabetes or family history of diabetes, and preoperative HbA1c is =6%; 5) the disease is not self-limiting and there is no refractive medium opacity or pupil narrowing that affects the fundus examination; 6) there is no history of coronary heart disease, cerebrovascular disease, or drinking and smoking and coagulation function is normal; 7) except for calcium channel blockers, which are used to reduce blood pressure, they don't take any drugs at ordinary times; 8) body weight between 60 and 75 kg on admission; 9) the patient provides informed consent.

Exclusion criteria

Exclusion criteria: 1) The subjects who quit voluntarily and did not sign the informed consent form; 2) Patients who have taken diazepam and other psychotropic drugs at ordinary times; 3) There was a history of ataxia and tremor; 4) There was a history of rash and leucopenia; 5) Allergic to benzodiazepines; 6) Abnormal liver and kidney function and unstable blood pressure; 7) Insomnia, depression, central nervous system depression and other mental diseases; 8) Patients with myasthenia gravis, ADHD and COPD; 9) The operation time was more than 90 minutes; 10) There were cardiovascular events such as stroke, cerebral ischemia and myocardial infarction within 6 months before screening; 11) The target eye or the whole body exist diseases or conditions that the researchers believe that if they continue to participate in this study, the subjects may face greater risks (such as malignant hypertension, AIDS, malignant tumor, serious mental, cardiovascular, neurological, respiratory, digestive and other system diseases, or long-term use of hormones, immunodeficiency diseases, after heart stenting, after organ transplantation, etc.); 12) Those who did not use effective contraceptive measures, those who planned to get pregnant within 6 months, women in lactation and pregnancy; 13) In the course of the study, the researcher decided that it was not suitable to continue to participate in the experiment.

Design outcomes

Primary

MeasureTime frame
the effective rate of intraoperative blood pressure control;

Secondary

MeasureTime frame
The proportion of patients with systolic blood pressure higher than or equal to 180mmHg during operation;Number of patients with intraoperative and postoperative adverse reactions;

Countries

China

Contacts

Public ContactTianwei Qian

Shanghai General Hospital

qtw6180@126.com+86 15201955168

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 13, 2026