POCD - Postoperative Cognitive DysfunctionNCT04730596
Cognitive Dysfunction After Cataract Surgery
A study testing Ketamine, Dexmedetomidine and Normal saline in people with POCD - Postoperative Cognitive Dysfunction, run by Tanta University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- POCD - Postoperative Cognitive Dysfunction
- What is being tested?
- Ketamine, Dexmedetomidine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 15 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged more than 65 years presented for cataract surgery under peribulbar anesthesia.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ketamine and Dexmedetomidine on the Postoperative Cognitive Dysfunction After Cataract Surgery: Randomized Controlled Double-blinded Study
- 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.
- Being tested
- Ketamine, Dexmedetomidine, Normal saline
- Keywords
- Ketamine, Dexmedetomidine, cataract, Cognitive dysfunction
- Medical subject headings
- Postoperative Cognitive Complications, Cataract, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Ketamine at a dose of 0.3 mg/kg dissolved in normal saline.
DexmedetomidineDrug
Dexmedetomidine at a dose of 0.5 ug/kg dissolved in normal saline.
Normal salineDrug
Normal saline in a labeled syringe
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Throughout the whole intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start1 Feb 2021
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for POCD - Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Collaborators
- Magrabi Hospital - Doha
- Responsible party
- Principal investigator, Mohamed Elsayed Oriby, Tanta University
- Investigators
- Mohamed Oreby, M.D, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730596
- Sponsor's protocol ID
- MEEC-IRB- 2021-102
- Status last verified
- Apr 2021
- First submitted
- 26 Jan 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ketamine and Dexmedetomidine on the Postoperative Cognitive Dysfunction After Cataract Surgery: Randomized Controlled Double-blinded Study
- ClinicalTrials.gov ID
- NCT04730596
- Acronym / sponsor ID
- MEEC-IRB- 2021-102
- Keywords
- Ketamine, Dexmedetomidine, cataract, Cognitive dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Collaborators
- Magrabi Hospital - Doha
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (Control group) | Placebo comparator | Drug: Normal saline- 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. |
| Group II (Ketamine group) | Experimental | Drug: Ketamine- 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. |
| Group III (Dexmedetomidine group) | Experimental | Drug: Dexmedetomidine- 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients aged more than 65 years presented for cataract surgery under peribulbar anesthesia.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineKetamine at a dose of 0.3 mg/kg dissolved in normal saline. | Drug | Group II (Ketamine group) |
| DexmedetomidineDexmedetomidine at a dose of 0.5 ug/kg dissolved in normal saline. | Drug | Group III (Dexmedetomidine group) |
| Normal salineNormal saline in a labeled syringe | Drug | Group I (Control group) |
Primary outcome
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
1 secondary outcome
Change in the intraocular pressure
Time frame: Throughout the whole intraoperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Oreby, M.D principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine, Dexmedetomidine and Normal saline in people with POCD - Postoperative Cognitive Dysfunction, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The postoperative cognitive function (time frame: Within the first 3 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.