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Postoperative Cognitive DysfunctionPhase 2SPMSQ-ENCT02049411

Ketamine and Changes of the Short Portable Mental Status Questionnaire

A Phase 2 study testing Ketamine and physiological solution in people with Postoperative Cognitive Dysfunction, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Postoperative Cognitive Dysfunction
What is being tested?
Ketamine and physiological solution
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteMexico
Study dates
Jun 2013to May 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades

    Mexico City, Mexico City, 06720

Other trials in Mexico

About this study

Official title: Changes of the Short Portable Mental Status Questionnaire (SPMSQ-E) After Ketamine Administration on Ophthalmic Surgery in Geriatric Population.

  • 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.

Read more
  • 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-.
Read the 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.
Being tested
Ketamine, physiological solution
Keywords
Ketamine, acute cognitive dysfunction, geriatric patients
Medical subject headings
Postoperative Cognitive Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KetamineDrug

    Also called Ketalin, Ketalar, Ketanest

    Ketamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously.

  • physiological solutionDrug

    Also called Control, Placebo

    physiological solution at 0.9% (250 ml) during 2 hours, intravenously, with the same physical characteristics of ketamine.

Study groups in NCT02049411
Study groupRoleWhat they receive
Ketamine groupExperimentalKetamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously.
Receives: Drug: Ketamine; Drug: physiological solution
physiological solutionSham comparatorControl group: only physiological solution at 0.9% (250 ml) during 2 hours, intravenously.
Receives: Drug: physiological solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline to postoperative endpoint error scores on the Short Portable Mental Status Questionnaire (SPMSQ) in both groups

    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.

    Measured: Baseline, 2 hours after surgery

Secondary outcomes (6)

  1. Change in Hemodynamic measures

    Analysis of changes over time in hemodynamic parameters was done during the surgery

    Measured: Baseline, after Retrobulbar block , 90 minutes into surgery.

  2. Change in respiratory rate measures

    Analysis of changes over time in respiratory rate was done during the surgery with a general lineal model.

    Measured: Baseline, after Retrobulbar block , 90 minutes into surgery.

  3. Changes in oxygen saturation measures

    Analysis of changes over time in oxygen saturation measures was done during the surgery with a general lineal model

    Measured: Baseline, after Retrobulbar block , 90 minutes into surgery.

  4. Change in Ramsey Sedation Scale

    Sedation according to the Ramsey Scale from baseline to the final assessment (90minutes into surgery), was done with a general lineal model.

    Measured: Baseline, after retrobulbar block, 90 minutes into surgery

  5. Change on intraocular pressure measures

    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.

    Measured: Baseline (previous Retrobulbar block), end of surgery.

  6. Analgesia

    Analgesia was evaluated after regional anesthesia (retrobulbar block) and after surgery, a comparison was made between groups by the Chi-squared test (χ2).

    Measured: Changes in analgesia after regional anaesthesia (retrobulbar block). Changes in analgesia over 30 minutes after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2014 (estimated)
  2. Study startJun 2013
  3. Primary completionJan 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02049411
Sponsor's protocol ID
R-2012-3601-56
Acronym
SPMSQ-E
Status last verified
Nov 2014
First submitted
27 Jan 2014
Last updated
25 Nov 2014
Results posted
No
Data monitoring committee
No

Publications

  • Tolep K, Higgins N, Muza S, Criner G, Kelsen SG. Comparison of diaphragm strength between healthy adult elderly and young men. Am J Respir Crit Care Med. 1995 Aug;152(2):677-82. doi: 10.1164/ajrccm.152.2.7633725.

    PubMed 7633725

  • Phillips-Bute B, Mathew JP, Blumenthal JA, Grocott HP, Laskowitz DT, Jones RH, Mark DB, Newman MF. Association of neurocognitive function and quality of life 1 year after coronary artery bypass graft (CABG) surgery. Psychosom Med. 2006 May-Jun;68(3):369-75. doi: 10.1097/01.psy.0000221272.77984.e2.

    PubMed 16738066

  • Jones MJ, Piggott SE, Vaughan RS, Bayer AJ, Newcombe RG, Twining TC, Pathy J, Rosen M. Cognitive and functional competence after anaesthesia in patients aged over 60: controlled trial of general and regional anaesthesia for elective hip or knee replacement. BMJ. 1990 Jun 30;300(6741):1683-7. doi: 10.1136/bmj.300.6741.1683.

    PubMed 2390547

  • Tsai TL, Sands LP, Leung JM. An Update on Postoperative Cognitive Dysfunction. Adv Anesth. 2010;28(1):269-284. doi: 10.1016/j.aan.2010.09.003. No abstract available.

    PubMed 21151735

  • Caba F, Echevarria M, Cruz A, Rodriguez E, Llamas JM, Martinez MD, Rodriguez R. [Postoperative mental confusion in the elderly with hip fracture. Perioperative risk factors]. Rev Esp Anestesiol Reanim. 1994 Sep-Oct;41(5):255-61. Spanish.

    PubMed 7991903

  • Malouf R, Areosa Sastre A. Vitamin B12 for cognition. Cochrane Database Syst Rev. 2003;(3):CD004326. doi: 10.1002/14651858.CD004326.

    PubMed 12918012

  • Balk EM, Raman G, Tatsioni A, Chung M, Lau J, Rosenberg IH. Vitamin B6, B12, and folic acid supplementation and cognitive function: a systematic review of randomized trials. Arch Intern Med. 2007 Jan 8;167(1):21-30. doi: 10.1001/archinte.167.1.21.

    PubMed 17210874

  • Hudetz JA, Pagel PS. Neuroprotection by ketamine: a review of the experimental and clinical evidence. J Cardiothorac Vasc Anesth. 2010 Feb;24(1):131-42. doi: 10.1053/j.jvca.2009.05.008. Epub 2009 Jul 29. No abstract available.

    PubMed 19640746

  • Faden AI, Demediuk P, Panter SS, Vink R. The role of excitatory amino acids and NMDA receptors in traumatic brain injury. Science. 1989 May 19;244(4906):798-800. doi: 10.1126/science.2567056.

    PubMed 2567056

  • Hartvig P, Valtysson J, Lindner KJ, Kristensen J, Karlsten R, Gustafsson LL, Persson J, Svensson JO, Oye I, Antoni G, et al. Central nervous system effects of subdissociative doses of (S)-ketamine are related to plasma and brain concentrations measured with positron emission tomography in healthy volunteers. Clin Pharmacol Ther. 1995 Aug;58(2):165-73. doi: 10.1016/0009-9236(95)90194-9.

    PubMed 7648766

  • Pfeiffer E. A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients. J Am Geriatr Soc. 1975 Oct;23(10):433-41. doi: 10.1111/j.1532-5415.1975.tb00927.x.

    PubMed 1159263

  • Gonzalez Montalvo J I; Rodriguez L; Ruiperez I. Validacion del cuestionario de Pfeiffer y la escala de incapacidad mental de la cruz roja en la deteccion del deterioro mental en los pacientes externos de un servicio de Geriatria. Revista Española de Geriatría y Gerontología. 1991, 27 (3): 129-133.

  • Attix Deborah K, Welsh-Bohmer Kathleen A: Geriatric Neuropsychology: assessment and intervention. Guilford Press, 2006.

  • Hudetz JA, Iqbal Z, Gandhi SD, Patterson KM, Byrne AJ, Hudetz AG, Pagel PS, Warltier DC. Ketamine attenuates post-operative cognitive dysfunction after cardiac surgery. Acta Anaesthesiol Scand. 2009 Aug;53(7):864-72. doi: 10.1111/j.1399-6576.2009.01978.x. Epub 2009 Apr 28.

    PubMed 19422355

  • Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0.

    PubMed 9525362

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ketamine and physiological solution in people with Postoperative Cognitive Dysfunction, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline to postoperative endpoint error scores on the Short Portable Mental Status Questionnaire (SPMSQ) in both groups (time frame: Baseline, 2 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02049411, which also lists 39 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2014.

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