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Cognitive Dysfunction After Cataract Surgery

Primary Purpose

POCD - Postoperative Cognitive Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ketamine
Dexmedetomidine
Normal saline
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for POCD - Postoperative Cognitive Dysfunction focused on measuring Ketamine, Dexmedetomidine, cataract, Cognitive dysfunction

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Group I (Control group)

Group II (Ketamine group)

Group III (Dexmedetomidine group)

Arm Description

- 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.

- 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.

- 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.

Outcomes

Primary Outcome Measures

The postoperative cognitive function
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

Change in the intraocular pressure
The IOP will be measured before the peribulbar anesthesia, min, 5 min and 10 min after peribulbar injection, then immediately after surgery.

Full Information

First Posted
January 26, 2021
Last Updated
April 19, 2021
Sponsor
Tanta University
Collaborators
Magrabi Hospital - Doha
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1. Study Identification

Unique Protocol Identification Number
NCT04730596
Brief Title
Cognitive Dysfunction After Cataract Surgery
Official Title
The Effect of Ketamine and Dexmedetomidine on the Postoperative Cognitive Dysfunction After Cataract Surgery: Randomized Controlled Double-blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
April 15, 2021 (Actual)
Study Completion Date
April 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
Collaborators
Magrabi Hospital - Doha

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
POCD - Postoperative Cognitive Dysfunction
Keywords
Ketamine, Dexmedetomidine, cataract, Cognitive dysfunction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes 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
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (Control group)
Arm Type
Placebo Comparator
Arm Description
- 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.
Arm Title
Group II (Ketamine group)
Arm Type
Experimental
Arm Description
- 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.
Arm Title
Group III (Dexmedetomidine group)
Arm Type
Experimental
Arm Description
- 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 Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
Ketamine at a dose of 0.3 mg/kg dissolved in normal saline.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Dexmedetomidine at a dose of 0.5 ug/kg dissolved in normal saline.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Normal saline in a labeled syringe
Primary Outcome Measure Information:
Title
The postoperative cognitive function
Description
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
Time Frame
Within the first 3 days after surgery
Secondary Outcome Measure Information:
Title
Change in the intraocular pressure
Description
The IOP will be measured before the peribulbar anesthesia, min, 5 min and 10 min after peribulbar injection, then immediately after surgery.
Time Frame
Throughout the whole intraoperative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Oreby, M.D
Organizational Affiliation
Faculty of Medicine, Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Tanta
State/Province
Algharbia Governate
ZIP/Postal Code
31511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
till 6 months after approval of the publication of the trial.
IPD Sharing Access Criteria
Contact the principle investigator

Learn more about this trial

Cognitive Dysfunction After Cataract Surgery

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