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Efficacy and safety of preoperative oral diazepam in controlling intraoperative tension in patients undergoing vitrectomy under nerve block anesthesia

Efficacy and safety of preoperative oral diazepam in controlling intraoperative tension in patients undergoing vitrectomy under nerve block anesthesia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055955
Enrollment
Unknown
Registered
2022-01-29
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-07-15

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

Conditions

Patients who needed vitrectomy without hypertension

Interventions

Control group:Starch tablets were taken orally 60 minutes before operation
Experimental group:Diazepam were taken orally 60 minutes before operation

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged 18 years and over without operation history, hypertension and related cardiovascular and cerebrovascular diseases; 2. Blood pressure and preoperative blood pressure were less than 140 / 90mmHg three times at random on the day of admission; 3. After relevant examinations (slit lamp, fundus photography, Oct, ERG, FFA, ICGA, etc.) and combined with clinical diagnosis, the patient was diagnosed as rhegmatogenous retinal detachment, macular anterior membrane and macular hole. Vitrectomy under nerve block anesthesia was needed; 4. No history of diabetes and family history of diabetes, and preoperative glycosylated hemoglobin was less than or equal to 6%; 5. The course of the disease was not limited, and there was no refractive medium opacity and pupil narrowing that affected the fundus examination; 6. No history of coronary heart disease, cerebrovascular disease, alcoholism and smoking, and normal coagulation function; 7. The body weight is 50-75kg and the BMI is between 18.5 and 23.9; 8. Sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects who voluntarily withdrew and those who did not sign informed consent; 2. Patients who have taken diazepam and other psychotropic drugs orally at ordinary times; 3. History of ataxia and tremor; 4. History of rash and leucopenia; 5. Allergic to benzodiazepines; 6. In patients with abnormal liver and kidney function and unstable blood pressure at ordinary times, the preoperative systolic blood pressure was higher than 140mmHg; 7. Insomnia, depression, central nervous system depression, and other mental diseases; 8. Myasthenia gravis, ADHD, COPD; 9. Cardiovascular events such as stroke, cerebral ischemia and myocardial infarction occurred within 6 months before screening; 10.Researchers believe that if participants continue to participate in the study, they may face more risky diseases or conditions (such as malignant hypertension, AIDS, malignant tumors, severe mental, cardiovascular, neurological, respiratory, digestive and other systemic diseases, or long-term use of hormones, immunodeficiency diseases, cardiac stenting, organ transplantation, etc.); 11.Those who do not use effective contraceptives, those who plan to conceive within 6 months, lactating and pregnant women; 12.During the study, the researcher determined that it was not suitable to continue to participate in the experiment.

Design outcomes

Primary

MeasureTime frame
The change of mean systolic blood pressure measured by patients during operation from baseline;

Secondary

MeasureTime frame
The change of mean heart rate measured during operation from baseline;Number of patients with systolic blood pressure higher than 140mmHg;Number of patients with intraoperative and postoperative adverse reactions;

Countries

China

Contacts

Public ContactQian Tianwei

Shanghai General Hospital

qtw6180@126.com+86 15201955168

Outcome results

None listed

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