Changes of the Short Portable Mental Status Questionnaire (SPMSQ-E) After Ketamine Administration on Ophthalmic Surgery in Geriatric Population.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from baseline to postoperative endpoint error scores on the Short Portable Mental Status Questionnaire (SPMSQ) in both groups
研究概览
简要总结
- Cognitive changes are related to aging, affecting the performance of older patients in the solution of problems and the execution of tasks.
This phenomenon has been observed as a decline of neurophysiological domains, especially memory, and the velocity of thought.
- Anesthesia and surgery performed contributes to its development then, is named post-operative cognitive dysfunction (POCD). The incidence varies due to conditions of:
- Anesthesia and surgery.
- The time elapsed after surgery.
- The population studied, and the type of cognitive test employed.
- The aim of this study is to evaluate the changes around the Short Portable Mental Status Questionnaire (SPMSQ-E) after ketamine administration on ophthalmic surgery on the common conditions of geriatric patients, -comorbid and settings as minor surgery-.
详细描述
Participants will be patients programmed for a vitrectomy or cataract surgery involving a retrobulbar block, to be carried out with a local anesthesia.
- Administration of ketamine will be suspended during the study for any cause considered as a risk to the patient according to the judgment of the researchers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients be over 60 years and older.
- •Intraocular pressure less than 20 millimeter of mercury.
- •American Society of Anaesthesiologists (ASA) physical status classification, I-III.
排除标准
- •History of psychosis or schizophrenia.
- •Nephropathy.
- •Difficult to control hypertension.
- •Uncontrolled hepatic disorders.
- •Allergy to ketamine.
- •Moderate to severe depression.
- •Post-operative delirium.
- •Needed to use medications other than those contemplated in the study.
研究组 & 干预措施
Ketamine group
Ketamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously.
干预措施: Ketamine (Drug)
Ketamine group
Ketamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously.
干预措施: physiological solution (Drug)
physiological solution
Control group: only physiological solution at 0.9% (250 ml) during 2 hours, intravenously.
干预措施: physiological solution (Drug)
结局指标
主要结局
Change from baseline to postoperative endpoint error scores on the Short Portable Mental Status Questionnaire (SPMSQ) in both groups
时间窗: Baseline, 2 hours after surgery
Patients were included in an analysis of mean change from preoperative to postoperative assessment of the number of items missed on the SPMSQ using analysis of covariance (ANCOVA) model which contained baseline status as covariate, and the treatment group as the effect of interest.
次要结局
- Change on intraocular pressure measures(Baseline (previous Retrobulbar block), end of surgery.)
- Change in respiratory rate measures(Baseline, after Retrobulbar block , 90 minutes into surgery.)
- Change in Ramsey Sedation Scale(Baseline, after retrobulbar block, 90 minutes into surgery)
- Analgesia(Changes in analgesia after regional anaesthesia (retrobulbar block). Changes in analgesia over 30 minutes after surgery.)
- Changes in oxygen saturation measures(Baseline, after Retrobulbar block , 90 minutes into surgery.)
- Change in Hemodynamic measures(Baseline, after Retrobulbar block , 90 minutes into surgery.)
研究者
Dulce Maria Rascon Martinez
Anesthesiology - Pain Clinical professor.
Instituto Mexicano del Seguro Social