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Cognitive Dysfunction After Cataract Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04730596
Recruitment Status : Completed
First Posted : January 29, 2021
Last Update Posted : April 20, 2021
Sponsor:
Collaborator:
Magrabi Hospital - Doha
Information provided by (Responsible Party):
Mohamed Elsayed Oriby, Tanta University

Brief Summary:
  • Cataract surgery is commonly performed in elderly patients who are at high risk for developing postoperative cognitive dysfunction. Most cataract surgeries are performed under peribulbar or retrobulbar anesthesia, however, most of the patients require sedation to relieve the perioperative anxiety and induce amnesia. So, many sedative agents can be used especially benzodiazepines which may increase the risk of developing postoperative cognitive dysfunction.
  • Ketamine can be used as a sedative and analgesic agent in a dose of 0.25 -0.5 mg/kg with certain studies suggesting that it may decrease the risk of postoperative cognitive dysfunction. Similarly, dexmedetomidine can be used as a sedative and analgesic agent with the possibility of decreasing the incidence of postoperative cognitive dysfunction.
  • this controlled study will compare the effect of ketamine or dexmedetomidine on the POCD of patients undergoing cataract surgery.

Condition or disease Intervention/treatment Phase
POCD - Postoperative Cognitive Dysfunction Drug: Ketamine Drug: Dexmedetomidine Drug: Normal saline Not Applicable

Detailed Description:
  • Postoperative cognitive dysfunction is a common postoperative complication in elderly patients. Despite the role of the risk of anesthesia and/or surgery in developing postoperative cognitive dysfunction, it can be developed even with surgeries performed under local or regional anesthesia.
  • Ageing is the most common risk factor for developing postoperative cognitive dysfunction that can affect memory and speech. Also, impaired vision may be another important risk factor.
  • Cataract surgeries can be considered the most common surgery performed in elderly patients. It is usually performed under local anesthesia (peribulbar, retrobulbar, or sub-tenon blocks), however, sedation is usually required to relieve the anxiety of the patients and induce amnesia.
  • there are many sedative agents that can be used with such patients, the most commonly used are benzodiazepines. However, benzodiazepines use may increase the incidence of postoperative cognitive dysfunction.
  • Ketamine, the dissociative anesthetic, acts mainly through inhibition of NMDA receptors that reduce the neuronal loss of the cortex. it may attenuate the postoperative cognitive dysfunction and induce neuroprotective effect through suppressing the inflammatory response and minimizing cerebral ischemia.
  • dexmedetomidine is a sedative and analgesic agent that have the advantage of minimal respiratory depression and can be used as a sedative agent in cataract surgery. Studied revealed that its sedative analgesic effect is not associated with changes in memory.
  • This randomized controlled double-blinded study will be carried upon 90 elderly patients undergoing cataract surgery under peribulbar anesthesia where they will be classified into 3 groups: - Group I (Placebo Group). Where the patients will receive normal saline as a placebo.

Group II (Ketamine group). Where patients will receive ketamine in a dose of 0.3 mg/kg in physiological solution.

Group III (Dexmedetomidine group). where patients will receive dexmedetomidine in a dose of 0.5 ug/kg in a physiological solution.

-Primary outcome will be the incidence of POCD, the secondary outcomes will be the hemodynamic changes and the changes in the intraocular pressure.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
  • The patients will be blinded to their groups.
  • An anesthesia resident who will not participate in the study and have no the subsequent rule in it will help in the preparation of local anesthetic mixtures under strict aseptic precautions.
  • An assistant nurse who will be blinded to the study groups and will have no the subsequent rule in it will help in the collection of the data of measurements
Primary Purpose: Supportive Care
Official Title: The Effect of Ketamine and Dexmedetomidine on the Postoperative Cognitive Dysfunction After Cataract Surgery: Randomized Controlled Double-blinded Study
Actual Study Start Date : February 1, 2021
Actual Primary Completion Date : April 15, 2021
Actual Study Completion Date : April 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Placebo Comparator: Group I (Control group)
- The patients in this group will receive normal saline in a labeled syringe which will be prepared by an assistant nurse not participating in the study.
Drug: Normal saline
Normal saline in a labeled syringe

Experimental: Group II (Ketamine group)
- The patients in this group will receive ketamine at a dose of 0.3 mg/kg dissolved in normal saline in a labeled syringe which will be prepared by an assistant nurse not participating in the study.
Drug: Ketamine
Ketamine at a dose of 0.3 mg/kg dissolved in normal saline.

Experimental: Group III (Dexmedetomidine group)
- The patients in this group will receive Dexmedetomidine in a dose of 0.5 ug/kg dissolved in normal saline in a labeled syringe which will be prepared by an assistant nurse not participating in the study.
Drug: Dexmedetomidine
Dexmedetomidine at a dose of 0.5 ug/kg dissolved in normal saline.




Primary Outcome Measures :
  1. The postoperative cognitive function [ Time Frame: Within the first 3 days after surgery ]

    Short Portable Mental Status Questionnaire (SPMSQ) It is a score system that depends upon the number of errors in 10 questions asked to the patient where; - 0-2 errors: normal mental functioning

    3-4 errors: mild cognitive impairment

    5-7 errors: moderate cognitive impairment

    8 or more errors: severe cognitive impairment Mental Status Questionnaire (SPMSQ) score will be used to assess the cognitive dysfunction



Secondary Outcome Measures :
  1. Change in the intraocular pressure [ Time Frame: Throughout the whole intraoperative period ]
    The IOP will be measured before the peribulbar anesthesia, min, 5 min and 10 min after peribulbar injection, then immediately after surgery.



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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged more than 65 years presented for cataract surgery under peribulbar anesthesia.

Exclusion Criteria:

  • Patients with a history of psychological disorders as psychosis, schizophrenia, nephropathy.
  • Patients with uncontrolled medical conditions as D.M and hypertension.
  • Known allergy to the used medications
  • patients with hepatic, renal, or heart failure
  • Patients receiving anti-psychotic or anti-depressant medications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04730596


Locations
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Egypt
Faculty of Medicine
Tanta, Algharbia Governate, Egypt, 31511
Sponsors and Collaborators
Tanta University
Magrabi Hospital - Doha
Investigators
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Principal Investigator: Mohamed Oreby, M.D Faculty of Medicine, Tanta University
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Responsible Party: Mohamed Elsayed Oriby, Lecture of Anesthesia and Intensive Care - faculty of Medicine, Tanta University
ClinicalTrials.gov Identifier: NCT04730596    
Other Study ID Numbers: MEEC-IRB- 2021-102
First Posted: January 29, 2021    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data of the primary outcome will be available with the corresponding author till 6 months after approval of the publication of the trial.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: till 6 months after approval of the publication of the trial.
Access Criteria: Contact the principle investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Elsayed Oriby, Tanta University:
Ketamine
Dexmedetomidine
cataract
Cognitive dysfunction
Additional relevant MeSH terms:
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Cataract
Capsule Opacification
Postoperative Cognitive Complications
Cognitive Dysfunction
Lens Diseases
Eye Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Postoperative Complications
Pathologic Processes
Dexmedetomidine
Ketamine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics