Cognitive Dysfunction After Cataract Surgery

NCT04730596 | Completed

• 1 other identifier: MEEC-IRB- 2021-102
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

POCD - Postoperative Cognitive Dysfunction

Keywords

Ketamine; Dexmedetomidine; cataract; Cognitive dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

  Within the first 3 days after surgery

Secondary Outcomes (1)

• Change in the intraocular pressure

  Throughout the whole intraoperative period

Study Arms (3)

Group I (Control group)

PLACEBO COMPARATOR

\- 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

Group II (Ketamine group)

EXPERIMENTAL

\- 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

Group III (Dexmedetomidine group)

EXPERIMENTAL

\- 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

Interventions

Ketamine DRUG

Ketamine at a dose of 0.3 mg/kg dissolved in normal saline.

Group II (Ketamine group)

Dexmedetomidine DRUG

Dexmedetomidine at a dose of 0.5 ug/kg dissolved in normal saline.

Group III (Dexmedetomidine group)

Normal saline DRUG

Normal saline in a labeled syringe

Group I (Control group)

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead
• Magrabi Hospital - Doha: collaborator

Study Sites (1)

Faculty of Medicine

Tanta, Algharbia Governate, 31511, Egypt

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications; Cataract; Cognitive Dysfunction

Interventions

Ketamine; Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Mohamed Oreby, M.D

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: * 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecture of Anesthesia and Intensive Care - faculty of Medicine

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 29, 2021
• Study Start: February 1, 2021
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: till 6 months after approval of the publication of the trial.
• Access Criteria: Contact the principle investigator

Locations

EG (1)