A randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH): Rationale and design.

OBJECTIVE: Patients undergoing cardiac surgery are at risk of perioperative low cardiac output syndrome due to postoperative myocardial dysfunction. Myocardial dysfunction in patients undergoing cardiac surgery is a potential indication for the use of levosimendan, a calcium sensitizer with 3 beneficial cardiovascular effects (inotropic, vasodilatory, and anti-inflammatory), which appears effective in improving clinically relevant outcomes. DESIGN: Double-blind, placebo-controlled, multicenter randomized trial. SETTING: Tertiary care hospitals. INTERVENTIONS: Cardiac surgery patients (n = 1,000) with postoperative myocardial dysfunction (defined as patients with intraaortic balloon pump and/or high-dose standard inotropic support) will be randomized to receive a continuous infusion of either levosimendan (0.05-0.2 µg/[kg min]) or placebo for 24-48 hours. MEASUREMENTS AND MAIN RESULTS: The primary end point will be 30-day mortality. Secondary end points will be mortality at 1 year, time on mechanical ventilation, acute kidney injury, decision to stop the study drug due to adverse events or to start open-label levosimendan, and length of intensive care unit and hospital stay. We will test the hypothesis that levosimendan reduces 30-day mortality in cardiac surgery patients with postoperative myocardial dysfunction. CONCLUSIONS: This trial is planned to determine whether levosimendan could improve survival in patients with postoperative low cardiac output syndrome. The results of this double-blind, placebo-controlled randomized trial may provide important insights into the management of low cardiac output in cardiac surgery.

Auditory functional magnetic resonance in awake (nonsedated) and propofol-sedated children.

BACKGROUND: Functional Magnetic Resonance Imaging (fMRI) is often used in preoperative assessment before epilepsy surgery, tumor or cavernous malformation resection, or cochlear implantation. As it requires complete immobility, sedation is needed for uncooperative patients. OBJECTIVE: The aim of this study was to compare the fMRI cortical activation pattern after auditory stimuli in propofol-sedated 5- to 8-year-old children with that of similarly aged nonsedated children. METHODS: When possible, children underwent MRI without sedation, otherwise it was induced with i.v. propofol 2 mg·kg(-1) and maintained with i.v. propofol 4-5 mg·kg(-1) ·h(-1) . Following diagnostic MRI, fMRi was carried out, randomly alternating two passive listening tasks (a fairy-tale and nonsense syllables). RESULTS: We studied 14 awake and 15 sedated children. During the fairy-tale task, the nonsedated children's blood-oxygen-level-dependent (BOLD) signal was bilaterally present in the posterior superior temporal gyrus (STG), Wernicke's area, and Broca's area. Sedated children showed similar activation, with lesser extension to Wernicke's area, and no activation in Broca's area. During the syllable task, the nonsedated children's BOLD signal was bilaterally observed in the STG and Wernicke's area, in Broca's area with leftward asymmetry, and in the premotor area. In sedated children, cortical activation was present in the STG, but not in the frontal lobes. BOLD signal change areas in sedated children were less extended than in nonsedated children during both the fairy-tale and syllable tasks. Modeling the temporal derivative during both the fairy-tale and syllable tasks, nonsedated children showed no response while sedated children did. CONCLUSIONS: After auditory stimuli, propofol-sedated 5- to 8-year-old children exhibit an fMRI cortical activation pattern which is different from that in similarly aged nonsedated children.

Acupuncture accelerates recovery after general anesthesia: a prospective randomized controlled trial.

BACKGROUND: Acupuncture anesthesia was created in the 1950's in China and continues to be used there today during most major surgeries. It is widely used in China for such complex operations as brain, heart, and abdominal surgery. It is popular in China because it is economical, practical, and beneficial to the patients. With acupuncture anesthesia there is less bleeding during surgery and there is also quicker post-operative recovery. OBJECTIVE: This randomized prospective study aims at comparing the effect of two acupoints (Yongquan, KI1 and Renzhong, DU26) with sham acupuncture and no acupuncture on the time to recovery of consciousness after general anesthesia by means of the Bispectral Index monitor (BIS). DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: This is a prospective randomized controlled study. We randomly assigned 50 patients to 5 groups during recovery from surgical anesthesia. Four groups had acupuncture on KI1 (group A), DU26 (groups B), both KI1 and DU26 (group C), and sham points (group D), and one had no acupuncture (group E). MAIN OUTCOME MEASURES: Bispectral Index (BIS), time to spontaneous eye opening, time to tracheal extubation, and time to following commands were measured as the main outcome measures. RESULTS: Time to spontaneous eye opening differed among groups (P=0.002), as well as time to tracheal extubation (P<0.000 1) and time to following commands (P=0.000 6). BIS values differed significantly among groups both 5 and 10 min after the end of anesthesia (P<0.000 1 and P=0.000 4, respectively). BIS values of groups D and E were lower than those of the other groups and those of group C were higher. The same pattern was observed also 15 and 30 min after the end of anesthesia, although the difference among groups was not significant at these time points (P=0.164 and P=0.104, respectively). CONCLUSION: Acupuncture on DU26 and KI1 accelerates recovery of consciousness after general anesthesia. Moreover, a possible synergistic effect of DU26 and KI1 is suggested. This issue may play a role in the optimization of operating room management and raise interest about the usefulness of acupuncture on unconsciousness states of different nature.

Acupuncture accelerates recovery after general anesthesia: a prospective randomized controlled trial / 中西医结合学报

Acupuncture anesthesia was created in the 1950's in China and continues to be used there today during most major surgeries. It is widely used in China for such complex operations as brain, heart, and abdominal surgery. It is popular in China because it is economical, practical, and beneficial to the patients. With acupuncture anesthesia there is less bleeding during surgery and there is also quicker post-operative recovery.

Anesthesiologist intervention during cataract surgery under topical or peribulbar anesthesia: a propensity model comparison.

PURPOSE: To compare the incidence and type of anesthesiologist intervention during cataract surgery under peribulbar (PA) or topical (TLA) anesthesia in a day-surgery monitored anesthesia care setting (monitoring provided by nurses with the anesthesiologist available on an on-call basis). METHODS: From a prospective database of all phacoemulsifications performed in our hospital (January 2008-January 2009), 97 patients submitted to cataract surgery under PA were matched with 97 patients submitted to the same surgery under TA by a propensity model. The resulting groups were homogeneous as to history of antihypertensive therapy administered on the day of surgery and not administered on the day of surgery, cardiologic history, neurologic history, psychiatric history, anxiolytic assumption, and history of diabetes mellitus. We compared the incidence of intervention of the anesthesiologist between groups and the type of adverse event triggering such interventions. RESULTS: The anesthesiologist was called in 37(38.14%) cases in the PA group and in 27 (27.84%) cases in the TA group (37 [38.14%]) (p = 0.123). Only the occurrence of agitation differed significantly between groups (9 [9.28%] patients in the TA group vs 24 [24.74%] patients in the PA group; p = 0.004). CONCLUSIONS: Monitored anesthesia care is feasible for cataract surgery both under PA or TA. PA still remains an appealing alternative to TA during cataract surgery for patients incapable of keeping the operating eye in the primary position or with incoercible blinking, photophobia, or phacodonesis. A greater incidence of agitation is to be expected and adequate premedication with anxiolytics should be considered if PA is chosen.

Sedative effect of acupuncture during cataract surgery: prospective randomized double-blind study.

PURPOSE: To assess the effectiveness of acupuncture in reducing anxiety in patients having cataract surgery under topical anesthesia. SETTING: Vita-Salute University of Milan and IRCCS H. San Raffaele, Milan, Italy. METHODS: In a prospective randomized double-blind controlled trial, anxiety levels before and after cataract surgery in 3 groups (A = no acupuncture, B = true acupuncture starting 20 minutes before surgery, C = sham acupuncture starting 20 minutes before surgery) were compared using the Visual Analog Scale (VAS). Twenty-five patients scheduled for inpatient phacoemulsification were enrolled in each group. All surgeries were performed using topical anesthesia. Exclusion criteria were refusal to provide informed consent, use of drugs with sedative properties, psychiatric disease, pregnancy, knowledge of the principles of acupuncture, anatomic alterations, or cutaneous infections precluding acupuncture at the selected acupoints. RESULTS: Preoperative anxiety levels were significantly lower only in Group B (P = .001). Anxiety in Group B was significantly lower than in Group A (P = .001) and Group C (P = .037). Regarding postoperative anxiety, the mean VAS score was 39 +/- 5 in Group A, 19 +/- 3 in Group B, and 31 +/- 4 in Group C. The difference was significant only between Group A and Group B (P = .003). CONCLUSION: Acupuncture was effective in reducing anxiety related to cataract surgery under topical anesthesia.

Bispectral index evaluation of the sedative effect of acupuncture in healthy volunteers.

OBJECTIVE: To evaluate the sedative effect of acupuncture in healthy volunteers by means of the BIS monitor. Secondary end-points were the evaluation of subjective sedative sensation induced by acupuncture and possible lasting of the sedative effect post needles removal. METHODS: We performed a cross-over, single-blinded study on 10 healthy volunteers to evaluate objective and subjective sedative effect of acupuncture compared to sham acupuncture. We recorded heart rate, pulse-oxymetry, BIS at baseline, during a 20-min. stimulation period, and for the following 20 minutes after needles removal. Besides, we asked volunteers to score their subjective state by VAS at baseline, after the stimulation period (20th minute) and 20 minutes after needles removal. RESULTS: BIS values were not significantly different between true and sham acupuncture. A suggestive but not statistically significant difference was evident in VAS score, with true- better than sham acupuncture. There was no difference in the incidence of sleep during the experimental phases, nor in the incidence of insomnia or somnolence in the following 24 hours. HR and SpO2 remained always in a normal range. CONCLUSIONS: The sedative effect of true acupuncture was not different from that of sham acupuncture in healthy volunteers. We suggest that acupuncture could have a mild sedative action that can be demonstrated only treating anxious patients and not calm volunteers. In our opinion, the low potency of this technique can be an advantage allowing acupuncture safe application in a wide range of settings.

Acupuncture for diagnostic fiberoptic bronchoscopy: a prospective, randomized, placebo-controlled study.

Patients usually fear fiberoptic bronchoscopy (FBS) and they report a low level of satisfaction after this examination. We evaluated the efficacy of acupuncture in decreasing patient anxiety before diagnostic FBS and in improving tolerance to the examination. In a prospective double-blind study, we enrolled 48 patients scheduled to undergo diagnostic FBS. Patients were randomly assigned to one of three groups. Group A (16 patients): standard FBS, with airway topic anesthesia; Group B (16 patients): standard FBS, with airway topic anesthesia and acupuncture treatment; Group C (16 patients): standard FBS, with airway topic anesthesia and sham acupuncture. EKG, non-invasive arterial pressure, and pulse oximetry were monitored on a routine basis. We evaluated patient anxiety before and after acupuncture and, at the end of FBS, the discomfort suffered during the examination by a 100-mm Visual Analog Scale (VAS). Patient satisfaction in Group A was 50% worse than in Group B (p = 0.04). We observed a strong, even if not statistically significant, tendency toward a lower pre-FBS anxiety in Group B. Patients in group C had values very close to those recorded in group A. We observed no adverse event and no differences in cardio-respiratory parameters in these three groups; in particular, we did not observe a respiratory depression in Group B. Acupuncture seems an effective resource for a Thoracic Endoscopic Room to improve patient tolerance to FBS.

Electroacupuncture analgesia for colonoscopy. a prospective, randomized, placebo-controlled study.

OBJECTIVE: A study was undertaken to compare the effectiveness of acupuncture in reducing patient's discomfort and anxiety during colonoscopy with a standard sedation protocol. METHODS: Thirty patients scheduled to undergo colonoscopy were randomly assigned to receive acupuncture, sham, or no acupuncture. A verbal rating scale was used to measure patient's pain when the endoscope reached four scheduled positions. Midazolam was administered at baseline and again anytime patients complained of "severe" pain. The amount of midazolam administered was recorded. A verbal rating scale was used to assess patient's satisfaction with the level of sedation achieved. RESULTS: Pain level was lower, although not significantly, in the acupuncture group. Midazolam boluses were required in three patients with acupuncture (30%), eight in the sham group (80%), and nine in the control group (90%) (p = 0.01). Six patients in the acupuncture group (60%) reported optimum acceptance of colonoscopy compared with only one in the sham group (10%) and none in the control group (0%) (p = 0.016). Satisfaction scores, assessed 24-72 h after colonoscopy, were extremely high (median score 90 of 100) in the three groups. CONCLUSIONS: Acupuncture may decrease the demand for sedative drugs during colonoscopy by reducing discomfort and anxiety of the patient and the well-known adverse effects of pharmacologic sedation.