A Prospective, Multicenter, Single-Blind Study Assessing Indices of SNAP II Versus BIS VISTA on Surgical Patients Undergoing General Anesthesia.

BACKGROUND: Traditionally, anesthesiologists have relied on nonspecific subjective and objective physical signs to assess patients' comfort level and depth of anesthesia. Commercial development of electrical monitors, which use low- and high-frequency electroencephalogram (EEG) signals, have been developed to enhance the assessment of patients' level of consciousness. Multiple studies have shown that monitoring patients' consciousness levels can help in reducing drug consumption, anesthesia-related adverse events, and recovery time. This clinical study will provide information by simultaneously comparing the performance of the SNAP II (a single-channel EEG device) and the bispectral index (BIS) VISTA (a dual-channel EEG device) by assessing their efficacy in monitoring different anesthetic states in patients undergoing general anesthesia. OBJECTIVE: The primary objective of this study is to establish the range of index values for the SNAP II corresponding to each anesthetic state (preinduction, loss of response, maintenance, first purposeful response, and extubation). The secondary objectives will assess the range of index values for BIS VISTA corresponding to each anesthetic state compared to published BIS VISTA range information, and estimate the area under the curve, sensitivity, and specificity for both devices. METHODS: This is a multicenter, prospective, double-arm, parallel assignment, single-blind study involving patients undergoing elective surgery that requires general anesthesia. The study will include 40 patients and will be conducted at the following sites: The Ohio State University Medical Center (Columbus, OH); Northwestern University Prentice Women's Hospital (Chicago, IL); and University of Miami Jackson Memorial Hospital (Miami, FL). The study will assess the predictive value of SNAP II versus BIS VISTA indices at various anesthetic states in patients undergoing general anesthesia (preinduction, loss of response, maintenance, first purposeful response, and extubation). The SNAP II and BIS VISTA electrode arrays will be placed on the patient's forehead on opposite sides. The hemisphere location for both devices' electrodes will be equally alternated among the patient population. The index values for both devices will be recorded and correlated with the scorings received by performing the Modified Observer's Assessment of Alertness and Sedation and the American Society of Anesthesiologists Continuum of Depth of Sedation, at different stages of anesthesia. RESULTS: Enrollment for this study has been completed and statistical data analyses are currently underway. CONCLUSIONS: The results of this trial will provide information that will simultaneously compare the performance of SNAP II and BIS VISTA devices, with regards to monitoring different anesthesia states among patients. CLINICALTRIAL: Clinicaltrials.gov NCT00829803; https://clinicaltrials.gov/ct2/show/NCT00829803 (Archived by WebCite at http://www.webcitation.org/6nmyi8YKO).

Postoperative epidural morphine for postpartum tubal ligation analgesia.

Women undergoing postoperative postpartum tubal ligation (PPTL) often experience considerable pain. We hypothesized that epidural morphine, as part of a multi-modal analgesic regimen, would decrease postoperative pain and the need for systemic analgesia after PPTL. In a double-blinded study, patients were randomized to receive epidural saline or morphine 2 mg, 3 mg, or 4 mg after epidural anesthesia for PPTL. Postoperatively, ibuprofen 600 mg was administered every 6 h and patients could request acetaminophen 325 mg/hydrocodone 10 mg. The primary outcome variable was time to first request for supplemental analgesia. Verbal rating scores for pain and the incidence and severity of side effects were recorded for 24 h. Morphine group subjects requested supplemental analgesia later and received fewer doses compared with the saline group subjects. Peak cramping and incisional verbal rating scores for pain and the area under the verbal rating scores for pain x time curve for cramping pain were less after epidural morphine compared with saline, but there were no differences among morphine groups. Nausea, vomiting, and pruritus occurred more often in all morphine groups and subjects who received morphine 4 mg required treatment for these side effects more frequently than the saline or morphine 2 mg groups. In conclusion, epidural morphine 2 mg as part of a multi-modal analgesic regimen improved analgesia and decreased the need for supplemental analgesics after PPTL. The need to treat side effects with morphine 2 mg was not increased compared to a regimen of oral acetaminophen/opioid/nonsteroidal antiinflammatory analgesics.

The risk of cesarean delivery with neuraxial analgesia given early versus late in labor.

BACKGROUND: Epidural analgesia initiated early in labor (when the cervix is less than 4.0 cm dilated) has been associated with an increased risk of cesarean delivery. It is unclear, however, whether this increase in risk is due to the analgesia or is attributable to other factors. METHODS: We conducted a randomized trial of 750 nulliparous women at term who were in spontaneous labor or had spontaneous rupture of the membranes and who had a cervical dilatation of less than 4.0 cm. Women were randomly assigned to receive intrathecal fentanyl or systemic hydromorphone at the first request for analgesia. Epidural analgesia was initiated in the intrathecal group at the second request for analgesia and in the systemic group at a cervical dilatation of 4.0 cm or greater or at the third request for analgesia. The primary outcome was the rate of cesarean delivery. RESULTS: The rate of cesarean delivery was not significantly different between the groups (17.8 percent after intrathecal analgesia vs. 20.7 percent after systemic analgesia; 95 percent confidence interval for the difference, -9.0 to 3.0 percentage points; P=0.31). The median time from the initiation of analgesia to complete dilatation was significantly shorter after intrathecal analgesia than after systemic analgesia (295 minutes vs. 385 minutes, P<0.001), as was the time to vaginal delivery (398 minutes vs. 479 minutes, P<0.001). Pain scores after the first intervention were significantly lower after intrathecal analgesia than after systemic analgesia (2 vs. 6 on a 0-to-10 scale, P<0.001). The incidence of one-minute Apgar scores below 7 was significantly higher after systemic analgesia (24.0 percent vs. 16.7 percent, P=0.01). CONCLUSIONS: Neuraxial analgesia in early labor did not increase the rate of cesarean delivery, and it provided better analgesia and resulted in a shorter duration of labor than systemic analgesia.