Use of dexmedetomidine for prophylactic analgesia and sedation in delayed extubation patients after craniotomy: a study protocol and statistical analysis plan for a randomized controlled trialReportar como inadecuado




Use of dexmedetomidine for prophylactic analgesia and sedation in delayed extubation patients after craniotomy: a study protocol and statistical analysis plan for a randomized controlled trial - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Trials

, 14:251

First Online: 13 August 2013Received: 11 June 2013Accepted: 07 August 2013DOI: 10.1186-1745-6215-14-251

Cite this article as: Zhao, LH., Shi, ZH., Yin, NN. et al. Trials 2013 14: 251. doi:10.1186-1745-6215-14-251

Abstract

BackgroundPain and agitation are common in patients after craniotomy. They can result in tachycardia, hypertension, immunosuppression, increased catecholamine production and increased oxygen consumption. Dexmedetomidine, an alpha-2 agonist, provides adequate sedation without respiratory depression, while facilitating frequent neurological evaluation.

Methods-designThe study is a prospective, randomized, double-blind, controlled, parallel-group design. Consecutive patients are randomly assigned to one of the two treatment study groups, labeled ‘Dex group’ or ‘Saline group.’ Dexmedetomidine group patients receive a continuous infusion of 0.6 μg-kg-h 10 ug-ml. Placebo group patients receive a maintenance infusion of 0.9% sodium chloride for injection at a volume and rate equal to that of dexmedetomidine. The mean percentages of time in optimal sedation, vital signs, various and adverse events, the percentage of patients requiring propofol for rescue to achieve-maintain targeted sedation Sedation-Agitation Scale, SAS 3 to 4 and total dose of propofol required throughout the study drug infusion are collected. The percentage of patients requiring fentanyl for additional rescue to analgesia and total dose of fentanyl required are recorded. The effects of dexmedetomidine on hemodynamic and recovery responses during extubation are measured. Intensive care unit and hospital length of stay also are collected. Plasma levels of epinephrine, norepinephrine, dopamine, cortisol, neuron-specific enolase and S100-B are measured before infusion T1, at two hours T2, four hours T3 and eight hours T4 after infusion and at the end of infusion T5 in 20 patients in each group.

DiscussionThe study has been initiated as planned in July 2012. One interim analysis advised continuation of the trial. The study will be completed in July 2013.

Trial registrationClinicalTrials NCT: ChiCTR-PRC-12002903.

KeywordsDexmedetomidine Analgesia Sedation Prophylactic Delayed extubation Craniotomy AbbreviationsAPACHE IIAcute Physiology and Chronic Health Evaluation II score

BPblood pressure

CNScentral nervous system

CPPcerebral perfusion pressure

CSFcerebrospinal fluid

GCSGlasgow Coma Scale

GCS-Mmotor responses to external stimuli in GCS

HRheart rate

ICPintracranial pressure

LClocus ceruleus

NSEneuron-specific enolase

RRrespiratory rate

SAHsubarachnoid hemorrhage

SASSedation-Agitation Scale

SpO2peripheral oxygen saturation.

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Autor: Li-Hong Zhao - Zhong-Hua Shi - Ning-Ning Yin - Jian-Xin Zhou

Fuente: https://link.springer.com/







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