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The effects of protective lung ventilation on regional cerebral oxygen saturation in intracranial tumor operation during dura opening: study protocol for a randomized controlled trial.

ABSTRACT: OBJECTIVE:The objective of this trial is to investigate the effects of protective lung ventilation on regional cerebral oxygen saturation (rSO2) during dura opening, that is from Ta (after dura opening) to Tb (before dura closing), in patients undergoing intracranial tumor surgery. METHODS:This is a randomized controlled trial which will be carried out at the Second Affiliated Hospital of Soochow University. Fifty-four patients undergoing intracranial tumor surgery will be randomly allocated to the control group (C group) or the protective lung ventilation group (P group). In the C group, the tidal volume (VT) will be set at 8?ml/kg of predicted body weight, but positive end-expiratory pressure (PEEP) and recruitment maneuvers will not be used. In the P group, VT will be set at 6?ml/kg of predicted body weight combined with individualized PEEP during dura opening, while in other periods of general anesthesia, VT will be set at 8?ml/kg of predicted body weight. The level of rSO2, partial pressures of oxygen and carbon dioxide, oxygenation index, lactic acid level in arterial blood, and mean arterial pressure will be compared before anesthesia (T0), before dura opening (T1), after dura closing (T2), and 24?h after surgery (T3). Lung ultrasound scores will be measured at T0 and T3. The degree of brain relaxation at T1 and T2 will be evaluated by the surgeon using the brain relaxation scale. The amount of vasoactive drugs used and blood loss will be recorded during surgery. The duration of operation and reoperation rate will be recorded. The primary outcome of this study is the changes in rSO2 within 24?h postoperatively. DISCUSSION:This study aims to determine whether protective lung ventilation during dura opening can improve rSO2 and the state of pulmonary ventilation in patients undergoing intracranial tumor surgery, and to investigate whether this strategy affects the degree of brain tissue swelling and the reoperation rate after operation. If our results are positive, this study will show that protective lung ventilation during dura opening can be used effectively and safely in neurosurgical patients undergoing craniotomy for tumor resection. TRIAL REGISTRATION:Chinese Clinical Trial Registry, ChiCTR1900025632. Registered on 3 September 2019. chictr.org.cn.

SUBMITTER: Li J

PROVIDER: S-EPMC7006087 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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The effects of protective lung ventilation on regional cerebral oxygen saturation in intracranial tumor operation during dura opening: study protocol for a randomized controlled trial.

Li Jinlu J Wu Xuemei X Liu Hairui H Huang Ying Y Liu Yueqin Y Xie Hong H Dong Jun J

Trials 20200207 1

<h4>Objective</h4>The objective of this trial is to investigate the effects of protective lung ventilation on regional cerebral oxygen saturation (rSO<sub>2</sub>) during dura opening, that is from Ta (after dura opening) to Tb (before dura closing), in patients undergoing intracranial tumor surgery.<h4>Methods</h4>This is a randomized controlled trial which will be carried out at the Second Affiliated Hospital of Soochow University. Fifty-four patients undergoing intracranial tumor surgery will ...[more]

PMID: 32033612

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Project description:Background Perioperative neurocognitive disorders (PND) is a common postoperative complication including postoperative delirium (POD), postoperative cognitive decline (POCD) or delayed neurocognitive recovery. It is still controversial whether the use of intraoperative cerebral function monitoring can decrease the incidence of PND. The purpose of this study was to evaluate the effects of different cerebral function monitoring (electroencephalography (EEG) and regional cerebral oxygen saturation (rSO2) monitoring) on PND based on the data from randomized controlled trials (RCTs). Methods The electronic databases of Ovid MEDLINE, PubMed, EMBASE, Cochrane Library database were systematically searched using the indicated keywords from their inception to April 2020. The odds ratio (OR) or mean difference (MD) with 95% confidence interval (CI) were employed to analyze the data. Heterogeneity across analyzed studies was assessed with chi-square test and I2 test. Results Twenty two RCTs with 6356 patients were included in the final analysis. Data from 12 studies including 4976 patients were analyzed to assess the association between the EEG-guided anesthesia and PND. The results showed that EEG-guided anesthesia could reduce the incidence of POD in patients undergoing non-cardiac surgery (OR: 0.73; 95% CI: 0.57–0.95; P?=?0.02), but had no effect on patients undergoing cardiac surgery (OR: 0.44; 95% CI: 0.05–3.54; P?=?0.44). The use of intraoperative EEG monitoring reduced the incidence of POCD up to 3?months after the surgery (OR: 0.69; 95% CI: 0.49–0.96; P?=?0.03), but the incidence of early POCD remained unaffected (OR: 0.61; 95% CI: 0.35–1.07; P?=?0.09). The remaining 10 studies compared the effect of rSO2 monitoring to routine care in a total of 1380 participants on the incidence of PND. The results indicated that intraoperative monitoring of rSO2 could reduce the incidence of POCD (OR 0.53, 95% CI 0.39–0.73; P?<?0.0001), whereas no significant difference was found regarding the incidence of POD (OR: 0.74; 95% CI: 0.48–1.14; P?=?0.17). Conclusions The findings in the present study indicated that intraoperative use of EEG or/and rSO2 monitor could decrease the risk of PND. Trial registration PROSPREO registration number: CRD42019130512.

Project description:One of the main concerns of intraoperative hypotension is adequacy of cerebral perfusion, as cerebral blood flow decreases passively when mean arterial pressure falls below the lower limit of cerebral autoregulation. Treatment of intraoperative hypotension includes administration of drugs, such as inotropes and vasopressors, which have different pharmacological effects on cerebral hemodynamics; there is no consensus on the preferred drug to use. We performed a network meta-analysis (NMA) to pool and analyze data comparing the effect on cerebral oxygen saturation (ScO 2 ) measured by cerebral oximetry of various inotropes/vasopressors used to treat intraoperative hypotension. We searched randomized control trials in Embase, Ovid Medline, Scopus, Cochrane Central Register of Controlled Trials, and Web of Science. We included studies that enrolled adult patients undergoing surgery under general/spinal anesthesia that compared at least 2 inotropes/vasopressors to treat hypotension. We reviewed 51 full-text manuscripts and included 9 randomized controlled trials in our study. The primary outcome was change in ScO 2 . Our results showed the likelihood that dopamine, ephedrine, and norepinephrine had the lowest probability of decreasing ScO 2 . The suggested rank order to maintain ScO 2 , from higher to lower, was dopamine <ephedrine <norepinephrine <phenylephrine. Drugs in the lower rank order, like phenylephrine, produce higher reductions in ScO 2 . Compared with dopamine, the mean difference (95% credible interval) of ScO 2 reduction was: ephedrine -3.19 (-15.74, 8.82), norepinephrine -4.44 (-18.23, 9.63) and phenylephrine -6.93 (-18.31, 4.47). The results of our NMA suggest that dopamine and ephedrine are more likely to preserve ScO 2 , followed by norepinephrine. Compared with the other inotropes/vasopressors, phenylephrine decreased ScO 2 . Because of the inherent imprecision of direct/indirect comparisons, the rank orders are possibilities, not absolute ranks. Therefore the results of this NMA should be interpreted with caution.

Dataset Information

The effects of protective lung ventilation on regional cerebral oxygen saturation in intracranial tumor operation during dura opening: study protocol for a randomized controlled trial.

Publications

The effects of protective lung ventilation on regional cerebral oxygen saturation in intracranial tumor operation during dura opening: study protocol for a randomized controlled trial.

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