Ketamine and Changes of the Short Portable Mental Status Questionnaire
- Conditions
- Postoperative Cognitive Dysfunction
- Interventions
- Drug: physiological solution
- Registration Number
- NCT02049411
- Lead Sponsor
- Instituto Mexicano del Seguro Social
- Brief Summary
- 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:
1. Anesthesia and surgery.
2. The time elapsed after surgery.
3. 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-.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description physiological solution physiological solution Control group: only physiological solution at 0.9% (250 ml) during 2 hours, intravenously. Ketamine group physiological solution Ketamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously. Ketamine group Ketamine Ketamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously.
- Primary Outcome Measures
Name Time Method Change from baseline to postoperative endpoint error scores on the Short Portable Mental Status Questionnaire (SPMSQ) in both groups 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.
- Secondary Outcome Measures
Name Time Method Change on intraocular pressure measures Baseline (previous Retrobulbar block), end of surgery. Analysis of change in intraocular pressure over time was done previous retrobulbar block and at the end of surgery with a general lineal model over non-surgical eye.
Change in respiratory rate measures Baseline, after Retrobulbar block , 90 minutes into surgery. Analysis of changes over time in respiratory rate was done during the surgery with a general lineal model.
Change in Ramsey Sedation Scale Baseline, after retrobulbar block, 90 minutes into surgery Sedation according to the Ramsey Scale from baseline to the final assessment (90minutes into surgery), was done with a general lineal model.
Analgesia Changes in analgesia after regional anaesthesia (retrobulbar block). Changes in analgesia over 30 minutes after surgery. Analgesia was evaluated after regional anesthesia (retrobulbar block) and after surgery, a comparison was made between groups by the Chi-squared test (χ2).
Changes in oxygen saturation measures Baseline, after Retrobulbar block , 90 minutes into surgery. Analysis of changes over time in oxygen saturation measures was done during the surgery with a general lineal model
Change in Hemodynamic measures Baseline, after Retrobulbar block , 90 minutes into surgery. Analysis of changes over time in hemodynamic parameters was done during the surgery
Trial Locations
- Locations (1)
Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades
🇲🇽Mexico, Distrito Federal, Mexico