BACKGROUND: In this randomized, prospective trial, we sought to determine the effective dose of hypobaric ropivacaine with sufentanil providing 95% success (ED95) in spinal anesthesia for traumatic femoral neck surgery in the elderly. METHODS:Sixty-eight elderly patients with unilateral hip fracture randomly received 6, 8, 10, or 12 mg spinal hypobaric ropivacaine combined with 5 µg sufentanil. Patients remained in a lateral position for 15 minutes after spinal injection. The dose was considered successful if a unilateral sensory block >T12 was achieved, and there was no need for additional analgesia or conversion to general anesthesia. The ED95 was determined using logit analysis. The incidence of severe and very severe hypotension (systolic blood pressure decrease by >30% and >40% baseline, respectively) and the use of remifentanil were compared among groups using χ(2) test for trend. RESULTS: Three patients were excluded because of failure to reach the subarachnoid space. No differences in baseline demographic data were observed among groups. The ED95 for hypobaric ropivacaine was determined to be 9 mg (95% confidence interval, 8-14). Increasing doses of ropivacaine (6, 8, 10, and 12 mg) demonstrated a positive trend with respect to incidence of hypotension (53%, 47%, 87%, and 81%, P = 0.0004) and a negative trend with respect to the use of remifentanil (41%, 12%, 0%, and 0%, P = 0.0004). A significant difference in the level of sensory block (P < 0.0001) was observed among operative and nonoperative sides but not among ropivacaine dosing groups (P = 0.16). No difference in motor blockade, incidence of very severe hypotension, total dose of ephedrine, duration of surgery, patient satisfaction, operating conditions, or surgeon satisfaction scores was observed among groups. No cases of bradycardia were observed. No patient had a preoperative sensory level <T12 after 15 minutes in the lateral decubitus position, and no cases were converted to general anesthesia. There was no difference in undesirable outcomes or postoperative troponin values among groups. CONCLUSIONS: The effective dose of hypobaric ropivacaine combined with sufentanil 5 µg providing 95% success in spinal anesthesia for traumatic femoral neck surgery in the elderly is ED95 = 9 mg (95% confidence interval, 8-14). Using doses exceeding the ED95 may increase the incidence of hypotension. If doses less than the ED95 are chosen, the use of additional analgesia may be necessary.
RCT Entities:
BACKGROUND: In this randomized, prospective trial, we sought to determine the effective dose of hypobaric ropivacaine with sufentanil providing 95% success (ED95) in spinal anesthesia for traumatic femoral neck surgery in the elderly. METHODS: Sixty-eight elderly patients with unilateral hip fracture randomly received 6, 8, 10, or 12 mg spinal hypobaric ropivacaine combined with 5 µg sufentanil. Patients remained in a lateral position for 15 minutes after spinal injection. The dose was considered successful if a unilateral sensory block >T12 was achieved, and there was no need for additional analgesia or conversion to general anesthesia. The ED95 was determined using logit analysis. The incidence of severe and very severe hypotension (systolic blood pressure decrease by >30% and >40% baseline, respectively) and the use of remifentanil were compared among groups using χ(2) test for trend. RESULTS: Three patients were excluded because of failure to reach the subarachnoid space. No differences in baseline demographic data were observed among groups. The ED95 for hypobaric ropivacaine was determined to be 9 mg (95% confidence interval, 8-14). Increasing doses of ropivacaine (6, 8, 10, and 12 mg) demonstrated a positive trend with respect to incidence of hypotension (53%, 47%, 87%, and 81%, P = 0.0004) and a negative trend with respect to the use of remifentanil (41%, 12%, 0%, and 0%, P = 0.0004). A significant difference in the level of sensory block (P < 0.0001) was observed among operative and nonoperative sides but not among ropivacaine dosing groups (P = 0.16). No difference in motor blockade, incidence of very severe hypotension, total dose of ephedrine, duration of surgery, patient satisfaction, operating conditions, or surgeon satisfaction scores was observed among groups. No cases of bradycardia were observed. No patient had a preoperative sensory level <T12 after 15 minutes in the lateral decubitus position, and no cases were converted to general anesthesia. There was no difference in undesirable outcomes or postoperative troponin values among groups. CONCLUSIONS: The effective dose of hypobaric ropivacaine combined with sufentanil 5 µg providing 95% success in spinal anesthesia for traumatic femoral neck surgery in the elderly is ED95 = 9 mg (95% confidence interval, 8-14). Using doses exceeding the ED95 may increase the incidence of hypotension. If doses less than the ED95 are chosen, the use of additional analgesia may be necessary.