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Cognitive Dysfunction After Cataract Surgery

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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

Tracking Information
First Submitted Date  ICMJE January 26, 2021
First Posted Date  ICMJE January 29, 2021
Last Update Posted Date April 20, 2021
Actual Study Start Date  ICMJE February 1, 2021
Actual Primary Completion Date April 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2021)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2021)
The postoperative cognitive function [ Time Frame: Within the first 3 days after surgery ]
SPMSQ score will be used to assess the cognitive dysfuntion
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2021)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Dysfunction After Cataract Surgery
Official Title  ICMJE The Effect of Ketamine and Dexmedetomidine on the Postoperative Cognitive Dysfunction After Cataract Surgery: Randomized Controlled Double-blinded Study
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE POCD - Postoperative Cognitive Dysfunction
Intervention  ICMJE
  • Drug: Ketamine
    Ketamine at a dose of 0.3 mg/kg dissolved in normal saline.
  • Drug: Dexmedetomidine
    Dexmedetomidine at a dose of 0.5 ug/kg dissolved in normal saline.
  • Drug: Normal saline
    Normal saline in a labeled syringe
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Normal saline
  • 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.
    Intervention: Drug: Ketamine
  • 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.
    Intervention: Drug: Dexmedetomidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 19, 2021)
90
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2021)
120
Actual Study Completion Date  ICMJE April 15, 2021
Actual Primary Completion Date April 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04730596
Other Study ID Numbers  ICMJE MEEC-IRB- 2021-102
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: till 6 months after approval of the publication of the trial.
Access Criteria: Contact the principle investigator
Responsible Party Mohamed Elsayed Oriby, Tanta University
Study Sponsor  ICMJE Tanta University
Collaborators  ICMJE Magrabi Hospital - Doha
Investigators  ICMJE
Principal Investigator: Mohamed Oreby, M.D Faculty of Medicine, Tanta University
PRS Account Tanta University
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP