The Efficacy and Safety of Diazepam for Intraoperative Blood Pressure Stabilization in Hypertensive Patients Undergoing Vitrectomy Under Nerve Block Anesthesia: A Prospective, Single-Center, Double-Blind, Randomized, Controlled Trial

Abstract

Tianwei Qian,1– 5,* Qiaoyun Gong,1– 5,* Yiyang Shu,1– 5 Hangqi Shen,1– 5 Xia Wu,1– 5 Weijun Wang,1– 5 Zhihua Zhang,1– 5 Hui Cao,1– 5 Xun Xu1– 5 1Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai, People’s Republic of China; 2National Clinical Research Center for Eye Diseases, Shanghai, People’s Republic of China; 3Shanghai Key Laboratory of Ocular Fundus Diseases, Shanghai, People’s Republic of China; 4Shanghai Engineering Center for Visual Science and Photomedicine, Shanghai, People’s Republic of China; 5Shanghai Engineering Center for Precise Diagnosis and Treatment of Eye Disease, Shanghai, People’s Republic of China*These authors contributed equally to this workCorrespondence: Hui Cao; Zhihua Zhang, Tel [phone], Fax [phone], Email [email protected]; [email protected]: To evaluate the effectiveness and safety of diazepam in maintaining stable intraoperative blood pressure (BP) in hypertensive patients undergoing vitrectomy under nerve block anesthesia.Methods: A total of 180 hypertensive patients undergoing vitrectomy with nerve block anesthesia were randomized into two groups. The intervention group was given oral diazepam 60 min before operation, while the control group was given oral placebo 60 min before operation. The primary outcome is the effective rate of intraoperative BP control, defined as systolic blood pressure (SBP) during the operation maintained < 160 mmHg at all timepoints. The logistic regression model will be performed to analyze the compare risk factors for ineffective BP control.Results: The effective rate of intraoperative SBP control in the diazepam group was significant higher than that in the placebo group from 15 min to 70 min of the surgery (P < 0.05). The proportion of patients with SBP ≥ 180 mmHg at any timepoint from operation to 1 h postoperation was higher in the placebo group (12.22%) than in the diazepam group (2.22%) (P = 0.0096). We observed that the change in SBP from baseline consistently remained higher in the placebo group than in the diazepam group. In the logistic regression analysis, age, years of diagnosed hypertension and SBP 1h before surgery were significant risk factors for ineffective BP control.Conclusion: This study provides robust evidence supporting the effectiveness of oral diazepam as a pre-surgery intervention in maintaining stable blood pressure during vitrectomy in hypertensive patients.Trial Registration: Chinese Clinical Trial Registry (ChiCTR), ChiCTR2100041772.Keywords: nerve block anesthesia, vitrectomy, diazepam, blood pressure stabilization

Keywords

• nerve block anesthesia
• vitrectomy
• diazepam
• blood pressure stabilization