KetamineNCT07838909
Intraoperative Ketamine Versus Lidocaine Infusion on Postoperative Cognitive Dysfunction in Patients Undergoing Hip Surgery
A study testing Group Ketamine and Group Lidocaine in people with Ketamine and Cognitive, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare effects of ketamine versus lidocaine on postoperative cognitive dysfunction in geriatric patient undergoing hip surgery. Read more about this study
- Who is it for?
- Ages 66 years and older
- Conditions the study is for
- Ketamine, Cognitive, Dysfunction
- What is being tested?
- Group Ketamine and Group Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2025to 30 Mar 2026
- 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 66 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Both sexes of Elderly patient Aged >65 years.
- American Society of Anesthesiologists classification I-III.
- Undergoing hip surgery under spinal anesthesia.
Who cannot join
- Patient refusal.
- History of mental illness or scoring less than 8 using abbreviated mental test before operation as in table 3 .
- Obvious sinus bradycardia (heart rate of <50 beats per minute) or other serious cardiovascular diseases.
- Symptomatic cerebrovascular disease (such as previous stroke).
- History of liver and kidney dysfunction.
- Allergy to lidocaine or ketamine.
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- Metabolic disorders and fluid, electrolytes disturbances.
- Alcohol dependence or drug abuse.
- Redo surgery or infectious complications.
- Central nervous system medications (antipsychotics, anticonvulsants, antiparkinsonian, antidepressants).
- History of deep vein thrombosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intraoperative Ketamine Versus Lidocaine Infusion on Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Hip Surgery
This study aims to compare effects of ketamine versus lidocaine on postoperative cognitive dysfunction in geriatric patient undergoing hip surgery.
Read the detailed description
Hip arthroplasty remains one of the most commonly used and successful contemporary surgical interventions performed in older adults. Hip fractures in the elderly have emerged as a serious injury that incurs high medical costs and public resources due to long-term bed rest, limitations of independent daily living, or death, more than 28,000 hip fractures occur annually; this number is rapidly rising with the aging population) .
Despite successful surgery, patients still may suffer short- or long-term postoperative cognitive dysfunction , due to long operative times, extensive trauma, and the possibility of fat emboli .
POCD, which reflects a negative change in an individual's cognitive trajectory, has increasingly been recognized as a complication in elderly patients. It is characterized by disturbances in consciousness, orientation, thinking, memory, and executive function after surgical anesthesia .
The potential pathogenesis of postoperative cognitive dysfunction involves neuroinflammation and oxidative stress secondary to anesthesia and surgery. Post-surgery inflammation is characterized by increased levels of inflammatory cytokines and mediators and vascular permeability. Excessive inflammation can disrupt the body's immune system, potentially leading to certain inflammation-related conditions .
postoperative cognitive dysfunction is a neurological dysfunction which may last for weeks, months or years and can delay recovery, extend hospital stays, and even increase patient mortality. The incidence of postoperative cognitive dysfunction varies between 20 and 40% in patients over 60 years old. Therefore, it is important to develop new strategies to prevent postoperative cognitive dysfunction , especially in elderly patients . However, there is still unclear. on the methods and treatments used to prevent and treat postoperative cognitive dysfunction , including dexmedetomidine, ketamine, ulinastatin, parecoxib, midazolam, lidocaine, and dexamethasone.
Systemic lidocaine possesses analgesic, antihyperalgesic, prokinetic, and anti-inflammatory properties. It inhibits the release of proinflammatory cytokines and superoxide anions from activated neutrophils and blocks their accumulation at the injury site. The use of intravenous lidocaine infusions is associated with better pain relief, decreased risk of postoperative ileus, and improved enhanced recovery after surgery outcomes .
Ketamine, a non-competitive antagonist of N-methyl-d-aspartate receptors, exerts its primary mechanism of action by blocking N-methyl-d-aspartate receptors on gamma-aminobutyric acid interneurons and activating alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptors. Ketamine possesses anti-inflammatory properties, including the reduction of microglia activation as well as downregulation of pro-inflammatory cytokines . Hence, this study aims to compare effects of ketamine and lidocaine on postoperative cognitive dysfunction in geriatric hip surgery patients.
This study aims to compare effects of ketamine versus lidocaine on postoperative cognitive dysfunction in geriatric patient undergoing hip surgery.
- Conditions
- Ketamine, Cognitive, Dysfunction, Hip Surgeries
- Being tested
- Group Ketamine, Group Lidocaine, Group Placebo
- Keywords
- Hip Surgery, elderly, Ketamine, Cognitive Dysfunction, Lidocaine
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group KetamineDrug
Patients will receive ketamine as a bolus (0.5 mg/kg) after induction of spinal anesthesia, followed by a continuous infusion (0.2 mg/kg. h) until the end of surgery.
Group LidocaineDrug
Patients will receive lidocaine as a bolus (1.5 mg/kg) after induction of spinal anesthesia, followed by a continuous infusion (2 mg/kg. h) until the end of surgery
Group PlaceboDrug
Patients will receive placebo (saline) and administered in equal volumes and in the same manner as a control group.
| Study group | Role | What they receive |
|---|---|---|
| Group Ketamine | Experimental | Patients will receive ketamine as a bolus (0.5 mg/kg) after induction of spinal anesthesia, followed by a continuous infusion (0.2 mg/kg. h) until the end of surgery. Receives: Drug: Group Ketamine |
| Group Lidocaine | Experimental | Patients will receive lidocaine as a bolus (1.5 mg/kg) after induction of spinal anesthesia, followed by a continuous infusion (2 mg/kg. h) until the end of surgery. Receives: Drug: Group Lidocaine |
| Group Placebo | Placebo comparator | Patients will receive placebo (saline) and administered in equal volumes and in the same manner as a control group. Receives: Drug: Group Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative cognitive dysfunction
Measured: 3 days
Secondary outcomes (1)
Postoperative pain score
postoperative pain assessment with the Numerical rating Scale. Numerical rating Scale(0 represents "no pain") (1-3) mild pain; (4-6) moderate pain; (7-10) severe pain
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start30 Mar 2025
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KetamineStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marian Reda Abdou Gerges, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838909
- Sponsor's protocol ID
- 36265MD386/3/25
- Status last verified
- Mar 2025
- First submitted
- 18 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be available if it needed
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Ketamine Versus Lidocaine Infusion on Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Hip Surgery
- ClinicalTrials.gov ID
- NCT07838909
- Acronym / sponsor ID
- 36265MD386/3/25
- Conditions
- Ketamine, Cognitive, Dysfunction, Hip Surgeries
- Keywords
- Hip Surgery, elderly, Ketamine, Cognitive Dysfunction, Lidocaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Mar 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 24 Sep 2026 (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.
This study aims to compare effects of ketamine versus lidocaine on postoperative cognitive dysfunction in geriatric patient undergoing hip surgery.
Detailed description
Hip arthroplasty remains one of the most commonly used and successful contemporary surgical interventions performed in older adults. Hip fractures in the elderly have emerged as a serious injury that incurs high medical costs and public resources due to long-term bed rest, limitations of independent daily living, or death, more than 28,000 hip fractures occur annually; this number is rapidly rising with the aging population) .
Despite successful surgery, patients still may suffer short- or long-term postoperative cognitive dysfunction , due to long operative times, extensive trauma, and the possibility of fat emboli .
POCD, which reflects a negative change in an individual's cognitive trajectory, has increasingly been recognized as a complication in elderly patients. It is characterized by disturbances in consciousness, orientation, thinking, memory, and executive function after surgical anesthesia .
The potential pathogenesis of postoperative cognitive dysfunction involves neuroinflammation and oxidative stress secondary to anesthesia and surgery. Post-surgery inflammation is characterized by increased levels of inflammatory cytokines and mediators and vascular permeability. Excessive inflammation can disrupt the body's immune system, potentially leading to certain inflammation-related conditions .
postoperative cognitive dysfunction is a neurological dysfunction which may last for weeks, months or years and can delay recovery, extend hospital stays, and even increase patient mortality. The incidence of postoperative cognitive dysfunction varies between 20 and 40% in patients over 60 years old. Therefore, it is important to develop new strategies to prevent postoperative cognitive dysfunction , especially in elderly patients . However, there is still unclear. on the methods and treatments used to prevent and treat postoperative cognitive dysfunction , including dexmedetomidine, ketamine, ulinastatin, parecoxib, midazolam, lidocaine, and dexamethasone.
Systemic lidocaine possesses analgesic, antihyperalgesic, prokinetic, and anti-inflammatory properties. It inhibits the release of proinflammatory cytokines and superoxide anions from activated neutrophils and blocks their accumulation at the injury site. The use of intravenous lidocaine infusions is associated with better pain relief, decreased risk of postoperative ileus, and improved enhanced recovery after surgery outcomes .
Ketamine, a non-competitive antagonist of N-methyl-d-aspartate receptors, exerts its primary mechanism of action by blocking N-methyl-d-aspartate receptors on gamma-aminobutyric acid interneurons and activating alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptors. Ketamine possesses anti-inflammatory properties, including the reduction of microglia activation as well as downregulation of pro-inflammatory cytokines . Hence, this study aims to compare effects of ketamine and lidocaine on postoperative cognitive dysfunction in geriatric hip surgery patients.
This study aims to compare effects of ketamine versus lidocaine on postoperative cognitive dysfunction in geriatric patient undergoing hip surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Ketamine | Experimental | Drug: Group KetaminePatients will receive ketamine as a bolus (0.5 mg/kg) after induction of spinal anesthesia, followed by a continuous infusion (0.2 mg/kg. h) until the end of surgery. |
| Group Lidocaine | Experimental | Drug: Group LidocainePatients will receive lidocaine as a bolus (1.5 mg/kg) after induction of spinal anesthesia, followed by a continuous infusion (2 mg/kg. h) until the end of surgery. |
| Group Placebo | Placebo comparator | Drug: Group PlaceboPatients will receive placebo (saline) and administered in equal volumes and in the same manner as a control group. |
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Both sexes of Elderly patient Aged >65 years.
- American Society of Anesthesiologists classification I-III.
- Undergoing hip surgery under spinal anesthesia.
Key exclusion criteria (11 listed)
- Patient refusal.
- History of mental illness or scoring less than 8 using abbreviated mental test before operation as in table 3 .
- Obvious sinus bradycardia (heart rate of <50 beats per minute) or other serious cardiovascular diseases.
- Symptomatic cerebrovascular disease (such as previous stroke).
- History of liver and kidney dysfunction.
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 |
|---|---|---|
| Group KetaminePatients will receive ketamine as a bolus (0.5 mg/kg) after induction of spinal anesthesia, followed by a continuous infusion (0.2 mg/kg. h) until the end of surgery. | Drug | Group Ketamine |
| Group LidocainePatients will receive lidocaine as a bolus (1.5 mg/kg) after induction of spinal anesthesia, followed by a continuous infusion (2 mg/kg. h) until the end of surgery | Drug | Group Lidocaine |
| Group PlaceboPatients will receive placebo (saline) and administered in equal volumes and in the same manner as a control group. | Drug | Group Placebo |
Primary outcome
Incidence of postoperative cognitive dysfunction
Time frame: 3 days
1 secondary outcome
Postoperative pain score
Time frame: 24 hours postoperatively
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 24 Sep 2026.
- Individual participant dataSharing planned: Yes. It will be available if it needed
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Ketamine and Group Lidocaine in people with Ketamine and Cognitive, 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 3 inclusion and 11 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 24 Sep 2026. 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?
Incidence of postoperative cognitive dysfunction (time frame: 3 days). 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 24 Sep 2026.