Cognitive Dysfunction After Cataract Surgery

Sponsor
Tanta University (Other)
Overall Status
Completed
CT.gov ID
NCT04730596
Collaborator
Magrabi Hospital - Doha (Other)
90
1
3
2.4
37.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
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 :
Feb 1, 2021
Actual Primary Completion Date :
Apr 15, 2021
Actual Study Completion Date :
Apr 15, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The postoperative cognitive function [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine Tanta Algharbia Governate Egypt 31511

Sponsors and Collaborators

  • Tanta University
  • Magrabi Hospital - Doha

Investigators

  • Principal Investigator: Mohamed Oreby, M.D, Faculty of Medicine, Tanta University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Jan 29, 2021
Last Update Posted:
Apr 20, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mohamed Elsayed Oriby, Lecture of Anesthesia and Intensive Care - faculty of Medicine, Tanta University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 20, 2021