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CompletedNCT04730596Updated Apr 20, 2021

Cognitive Dysfunction After Cataract Surgery

An interventional study of Ketamine and Dexmedetomidine in POCD - Postoperative Cognitive Dysfunction, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-04-20.

Sponsored by Tanta University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
65 Years to 85 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • POCD - Postoperative Cognitive Dysfunction

Keywords

  • Ketamine
  • Dexmedetomidine
  • cataract
  • Cognitive dysfunction
03

Who can participate

Ages eligible
65 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • DrugKetamine

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

  • DrugDexmedetomidine

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

  • DrugNormal saline

    Normal saline in a labeled syringe

05

What researchers measure

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

    Time frame: Within the first 3 days after surgery

Secondary outcomes

  1. 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.

    Time frame: Throughout the whole intraoperative period

06

Study locations

1 site
  • Faculty of Medicine
    Tanta, Algharbia Governate 31511, Egypt
07

References and documents

Individual participant data

Plan to share: Yes — 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 information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04730596
Lead sponsor
Tanta University
Collaborators
Magrabi Hospital - Doha
Responsible party
Mohamed Elsayed Oriby (Lecture of Anesthesia and Intensive Care - faculty of Medicine, Tanta University) — Principal investigator
First posted
Jan 29, 2021
Start date
Feb 1, 2021
Primary completion
Apr 15, 2021
Completion
Apr 15, 2021
Last update
Apr 20, 2021

Study contacts

Mohamed Oreby, M.D
principal investigator · Faculty of Medicine, Tanta University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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