Abstract
A double-blind clinical trial was conducted in 192 hypertensive patients in 17 institutes to assess the safety and efficacy of TN-873R (nifedipine suppository) in treating hypertension during perioperative period. Ninety five patients received TN-873R as a preanesthetic medication and 97 control patients received inactive placebo.
The blood pressure level of TN-873R group was significantly lower than placebo group. The other antihypertensive drugs were less frequently needed in patients of TN-873R group (8.3%) than placebo group (32.6%). Prescribed frequency of vasopressor due to unexpected severe hypotension was not significantly different in both groups. The incidence of side effects was statistically the same in both groups and severe side effects were not observed. Anesthesiologists participating in the trial indicated that TN-873R was useful.
The results suggest that preoperative administration of TN-873R is useful for the management of hypertensive patients during operation and anesthesia.