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Anaesthesiological strategies in elective craniotomy: randomized, equivalence, open trial--the NeuroMorfeo trial.

ABSTRACT: Many studies have attempted to determine the "best" anaesthetic technique for neurosurgical procedures in patients without intracranial hypertension. So far, no study comparing intravenous (IA) with volatile-based neuroanaesthesia (VA) has been able to demonstrate major outcome differences nor a superiority of one of the two strategies in patients undergoing elective supratentorial neurosurgery. Therefore, current practice varies and includes the use of either volatile or intravenous anaesthetics in addition to narcotics. Actually the choice of the anaesthesiological strategy depends only on the anaesthetists' preferences or institutional policies. This trial, named NeuroMorfeo, aims to assess the equivalence between volatile and intravenous anaesthetics for neurosurgical procedures.NeuroMorfeo is a multicenter, randomized, open label, controlled trial, based on an equivalence design. Patients aged between 18 and 75 years, scheduled for elective craniotomy for supratentorial lesion without signs of intracranial hypertension, in good physical state (ASA I-III) and Glasgow Coma Scale (GCS) equal to 15, are randomly assigned to one of three anaesthesiological strategies (two VA arms, sevoflurane + fentanyl or sevoflurane + remifentanil, and one IA, propofol + remifentanil). The equivalence between intravenous and volatile-based neuroanaesthesia will be evaluated by comparing the intervals required to reach, after anaesthesia discontinuation, a modified Aldrete score > or = 9 (primary end-point). Two statistical comparisons have been planned: 1) sevoflurane + fentanyl vs. propofol + remifentanil; 2) sevoflurane + remifentanil vs. propofol + remifentanil. Secondary end-points include: an assessment of neurovegetative stress based on (a) measurement of urinary catecholamines and plasma and urinary cortisol and (b) estimate of sympathetic/parasympathetic balance by power spectrum analyses of electrocardiographic tracings recorded during anaesthesia; intraoperative adverse events; evaluation of surgical field; postoperative adverse events; patient's satisfaction and analysis of costs. 411 patients will be recruited in 14 Italian centers during an 18-month period.We presented the development phase of this anaesthesiological on-going trial. The recruitment started December 4th, 2007 and up to 4th, December 2008, 314 patients have been enrolled.

SUBMITTER: Citerio G

PROVIDER: S-EPMC2673222 | biostudies-literature | 2009 Apr

REPOSITORIES: biostudies-literature

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Anaesthesiological strategies in elective craniotomy: randomized, equivalence, open trial--the NeuroMorfeo trial.

Citerio Giuseppe G Franzosi Maria Grazia MG Latini Roberto R Masson Serge S Barlera Simona S Guzzetti Stefano S Pesenti Antonio A

Trials 20090406

<h4>Background</h4>Many studies have attempted to determine the "best" anaesthetic technique for neurosurgical procedures in patients without intracranial hypertension. So far, no study comparing intravenous (IA) with volatile-based neuroanaesthesia (VA) has been able to demonstrate major outcome differences nor a superiority of one of the two strategies in patients undergoing elective supratentorial neurosurgery. Therefore, current practice varies and includes the use of either volatile or intr ...[more]

PMID: 19348675

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Project description:BackgroundPain is often observed in pediatric patients after craniotomy procedures, which could lead to some serious postoperative complications. However, the optimal formula for postoperative analgesia for pediatric neurosurgery has not been well established. This study aimed to explore the optimal options and formulas for postoperative analgesia in pediatric neurosurgery.MethodsThree hundred and twenty patients aged 1 to 12-years old who underwent craniotomy were randomly assigned to receive 4 different regimens of patient-controlled analgesia. The formulas used were as follows: Control group included normal saline 100 ml, with a background infusion of 2 ml/h, bolus 0.5 ml; Fentanyl group was used with a background infusion of 0.1-0.2 μg/k·h, bolus 0.1-0.2 μg/kg; Morphine group was used with a background infusion of 10-20 μg/kg·h, bolus 10-20 μg/kg; while Tramadol group was used with a background infusion of 100-400 μg/kg·h, bolus 100-200 μg/kg. Postoperative pain scores and analgesia-related complication were recorded respectively. Comparative analysis was performed between the four groups.ResultsIn comparison of all groups with each other, lower pain scores were shown at 1 h and 8 h after surgery in Morphine group versus Tramadol, Fentanyl and Control groups (P < 0.05). Both Tramadol and Fentanyl groups showed lower pain scores in comparison to Control group (P < 0.05). Nausea and vomiting were observed more in Tramadol group in comparison to all other groups during the 48 h of PCIA usage after operation (P = 0.020). Much more rescue medicines including ibuprofen and morphine were used in Control group (CI = 0.000-0.019). Changes in consciousness and respiratory depression were not observed in study groups. Moderate-to-severe pain was observed in a total of 56 (17.5%) of the study population. Multiple regression analysis for identifying risk factors for moderate-to-severe pain revealed that, younger children (OR = 1.161, 1.027-1.312, P = 0.017), occipital craniotomy (OR = 0.374, 0.155-0.905, P = 0.029), and morphine treatment (OR = 0.077, 0.021-0.281, P < 0.001) are the relevant factors.ConclusionsCompared with other analgesic projects, PCIA or NCIA analgesia with morphine appears to be the safest and most effective postoperative analgesia program for pediatric patients who underwent neurosurgical operations.Trial registrationChinese Clinical Trial Registry. No: ChiCTR-IOC-15007676. Prospective registration. http://www.chictr.org.cn/index.aspx .

Project description:BackgroundIt is important to manage inflammation after craniotomy. It may be prudent to reduce the excessive usage of antibiotics and to add supplementary treatments like acupuncture, which would be effective and safe. However, there are only a few studies available to date on the effects of acupuncture on anti-inflammatory response after craniotomy. The aim of this study was to explore the anti-inflammatory effects of acupuncture in patients after a craniotomy.MethodsThis study was a single-center, prospective, open-label, controlled trial. Forty-four subjects who underwent craniotomy for an unruptured aneurysm, facial spasm, or brain tumor were allocated to either an acupuncture group or a control group. Both groups received postoperative routine care in the Department of Neurosurgery. The subjects in the acupuncture group also received a total of 6 acupuncture treatments sessions within 8 days after craniotomy. Acupuncture treatments included acupuncture, electroacupuncture, and intradermal acupuncture. The serum interleukin (IL)-1β and IL-6, tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), and erythrocyte sedimentation rate levels were assessed four times within 7 days after surgery. The presence of fever, use of additional antibiotics, presence of infection including pneumonia or urinary tract infection, and safety were also reviewed.ResultsThe IL-1β levels of subjects who underwent aneurysmal clipping were significantly lower in the acupuncture group (P = .02). TNF-α levels of subjects who underwent aneurysmal clipping at the seventh postoperative day were also significantly lower in the acupuncture group (P = .03). Six cases of fever of unknown origin were observed in the control group, while none were seen in the acupuncture group, revealing that the incidence of fever was significantly lower in the acupuncture group (P = .02). No adverse events occurred during the trial.ConclusionAcupuncture showed a possibility of alleviating inflammation by attenuating the levels of proinflammatory cytokines and significantly reduced the incidence of fever of unknown origin in patients after craniotomy. Acupuncture would be suitable as an adjunctive therapy to alleviate inflammation after craniotomy.

Project description:Purpose: Whole body vibration (WBV) triggers anabolic responses in various tissues, including tendons, without requiring high force production. In this waitlist-controlled equivalence trial, we tested its clinical effectiveness as an alternative treatment for patellar tendinopathy against conventional heavy slow resistance training (HSR). Methods: Thirty-nine patients were randomized to either 3 months of WBV training (n = 13), HSR training (n = 11), or a waitlist control (WLC) group (n = 15). In a partly cross-over design, 14 patients of the WLC group were redistributed to one of the two intervention groups (5 in WBV, 9 in HSR). Pre- and post-intervention testing included pain assessments (VAS), functional limitations (VISA-P), knee extension strength and tendon morphological, mechanical and material properties. Follow-up measurements (VAS, VISA-P) were performed in the WBV and HSR groups 6 months after the intervention. Results: Comparisons with the WLC group revealed significant improvements in VISA-P and VAS scores after HSR (41%, p = 003; 54%, p = 0.005) and WBV (22%, p = 0.022; 56%, p = 0.031) training. These improvements continued until follow-up (HSR: 43%, 56%; WBV: 24%, 37%). Pre-post improvements in VAS scores were equivalent between WBV and HSR groups but inconclusive for the VISA-P score and all pre-test to follow up comparisons. The mid-tendon cross-sectional area was significantly reduced after WBV (-5.7%, p = 0.004) and HSR (-3.0%, p = 0.004) training compared to WLC although the equivalence test between interventions was inconclusive. Conclusion: Whole body vibration improved symptoms typically associated with patellar tendinopathy. This type of intervention is as effective as HSR against maximum pain, although equivalence could not be confirmed for other variables. The beneficial responses to WBV and HSR treatments persisted for 6 months after the end of the intervention. Clinical Trial Registration: https://www.drks.de/drks_web/setLocale_EN.do, identifier DRKS00011338.

Project description:Postoperative bowel paralysis is common after abdominal operations, including colectomy. As a result, hospitalization may be prolonged, thereby leading to increased cost. A recent randomized controlled trial showed that the consumption of regular black coffee after colectomy is associated with a significantly faster resumption of intestinal motility. The mechanism by which coffee stimulates intestinal motility is unknown, but caffeine seems to be the most likely stimulating agent. Thus, the effect of caffeine on postoperative bowel activity after colon surgery will be analyzed in this trial, herein referred to as CaCo.Patients scheduled for elective laparoscopic colectomy or upper rectum resection are eligible to participate in this double-blinded, placebo-controlled, randomized trial. Patients fulfilling all inclusion criteria will be allocated after the surgical procedure to one of three treatment arms: 100 mg caffeine, 200 mg caffeine, or placebo (corn starch). Patients will take the capsules containing the study medication three times daily with a meal. The primary endpoint of the study is the time to a solid bowel movement. The study treatment will be stopped after the patient produces a solid bowel movement or has taken ten capsules, whichever occurs first. To determine the colonic passage time, patients will take a capsule with radiopaque markers at breakfast for the first 3 days after surgery. On the fourth day, the location of the markers will be determined with an abdominal X-ray scan. Further secondary objectives are the postoperative morbidity and mortality, well-being, sleeping behavior, and length of hospital stay. The study size was calculated to be 180 patients with an interim analysis occurring after 60 patients.From a previous study investigating coffee, evidence exists that caffeine might have a positive influence on the postoperative bowel activity. This double-blinded, placebo-controlled, randomized trial tries to show that caffeine will shorten the postoperative bowel paralysis and, thus, will improve recovery and shorten the hospital stay after colon surgery.Clinicaltrials.gov NCT02510911 Swiss National Clinical Trials Portal SNCTP000001131.

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Anaesthesiological strategies in elective craniotomy: randomized, equivalence, open trial--the NeuroMorfeo trial.

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Anaesthesiological strategies in elective craniotomy: randomized, equivalence, open trial--the NeuroMorfeo trial.

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