Cognitive Dysfunction After Cataract Surgery

POCD - Postoperative Cognitive Dysfunction Clinical Trial

Official title:

The Effect of Ketamine and Dexmedetomidine on the Postoperative Cognitive Dysfunction After Cataract Surgery: Randomized Controlled Double-blinded Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04730596
• Other study ID #: MEEC-IRB- 2021-102
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: April 15, 2021

Study information

• Verified date: April 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 15, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Cognitive Dysfunction
• POCD - Postoperative Cognitive Dysfunction

Intervention

Drug:
• Ketamine
Ketamine at a dose of 0.3 mg/kg dissolved in normal saline.
• Dexmedetomidine
Dexmedetomidine at a dose of 0.5 ug/kg dissolved in normal saline.
• Normal saline
Normal saline in a labeled syringe

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Tanta	Algharbia Governate

Sponsors (2)

Lead Sponsor	Collaborator
Tanta University	Magrabi Hospital - Doha

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Throughout the whole intraoperative period