Cognitive Dysfunction After Cataract Surgery
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|ClinicalTrials.gov Identifier: NCT04730596|
Recruitment Status : Completed
First Posted : January 29, 2021
Last Update Posted : April 20, 2021
- 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|
|POCD - Postoperative Cognitive Dysfunction||Drug: Ketamine Drug: Dexmedetomidine Drug: Normal saline||Not Applicable|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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 :||February 1, 2021|
|Actual Primary Completion Date :||April 15, 2021|
|Actual Study Completion Date :||April 15, 2021|
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.
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.
Dexmedetomidine at a dose of 0.5 ug/kg dissolved in normal saline.
- The postoperative cognitive function [ Time Frame: 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
- Change in the intraocular pressure [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04730596
|Faculty of Medicine|
|Tanta, Algharbia Governate, Egypt, 31511|
|Principal Investigator:||Mohamed Oreby, M.D||Faculty of Medicine, Tanta University|