Neurocognitive Function of Elderly PatientsNCT07497009
Effect of Lidocaine Infusion Versus Dexmedemidine Infusion on the Neurocognitive Function of Elderly Patients Undergoing Endoscopic Retrograde Cholangiopancreatography(ERCP).
A study testing Dexmedetomidine, lidocaine and normal saline in people with Neurocognitive Function of Elderly Patients, run by Benha University at 1 site in Egypt.
Trial summary
dexmedetomidine infusion or lidocaine infusion starting before induction of intravenous general anesthesia and continue as infusion intraoperative can reduce postoperative cognitive dysfunction incidence (primary outcome), postoperative cognitive dilirium, postoperative pain, opioid consumption, postoperative… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Neurocognitive Function of Elderly Patients
- What is being tested?
- Dexmedetomidine, lidocaine and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Dec 2024to 23 Aug 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Inclusion Criteria: The study will include all patients aged 65 years or older of both sex with an ASA I -II - III (as controlled HTN, controlled DM), (MMSE>24) who scheduled for elective ERCP under total intravenous general anesthesia.
Exclusion Criteria :will involve patients lacking informed consents, with severe cardiovascular, respiratory, central nervous system, or kidney dysfunction, communication or assessment impairments, and suspected severe neurocognitive impairment (MMSE score <24). patients with anticipated airway difficulties, alcohol or drug dependence, current sedative, antidepressant, or corticosteroid use, allergy to dexmedetomidine, lidocaine or other used anesthetics, baseline heart rate less than 50 beats per minute due to bradycardia, sick sinus syndrome, or second-degree or higher atrioventricular block without a pacemaker.
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Lidocine Infusion Versus Dexmedemidane Infusion on the Neurocognitive Function of Elderly Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP).
dexmedetomidine infusion or lidocaine infusion starting before induction of intravenous general anesthesia and continue as infusion intraoperative can reduce postoperative cognitive dysfunction incidence (primary outcome), postoperative cognitive dilirium, postoperative pain, opioid consumption, postoperative inflammatory response and postoperative adverse events (secondary outcomes) in elderly patients undergoing ERCP.
Read the detailed description
Randomization will be achieved using a computer-generated random sequence, and group allocation will be concealed using opaque, sealed envelopes. Both patients and study staff, including those administering the interventions and assessing outcomes will be blinded to the group assignments. The tested syringes will be prepared by the responsible nurse in equal volumes of 50 ml. All data of the patients will be confidential with secret codes and private file for each patient, all given data will be used for the current medical research only.
The prefilled 50 mL syringes will contain either dexmedetomidine 4 µg/mL or lidocaine 10 mg/mL or NaCl 0.9%. Ten minutes before anesthesia induction all patients will receive an IV infusion at a rate of 0.9mL/kg/h for 10 minutes. This rate corresponds to 0.6 µg/kg dexmedetomidine or 1.5 mg/kg lidocaine. Afterwards, all patients will receive an infusion at a rate of 0.15mL/kg/h until the end of procedure; this rate corresponds to 1.5 mg/kg/h of lidocaine or 0.6 µg/kg/h of dexmedetomidine.
- Being tested
- Dexmedetomidine, lidocaine, normal saline
- Keywords
- neurocognitive function, POCD, Dexmedetomidine, lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called precedex
patients will receive 0.6 µg/kg dexmedetomidine bolus 10 min before induction then it will be infused intravenously at a rate of 0.6 μg/Kg/h. until end of surgery.
lidocaineDrug
Also called xylocaine
patients will be received 1.5 mg/kg lidocaine bolus 10min before induction of anaesthesia, followed by continuous infusion at a rate of 1.5 mg/Kg/h until end of surgery.
normal salineDrug
Also called 0.9% sodium chloride
patients will receive 0.9% isotonic saline bolus followed by IV infusion at a rate of 0.9 ml/Kg/h till the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| group LIDO | Active comparator | Similar to other local anesthetics, lidocaine acts at sodium ion channels on the internal surface of nerve cell membranes. The uncharged form of lidocaine diffuses through neural sheaths into the axoplasm before ionizing by combining with hydrogen ions. The resulting cation binds reversibly to sodium channels from the inside, locking them in the open state and preventing nerve depolarization. Receives: Drug: lidocaine |
| group DEX | Experimental | The sedative and analgesic effects induced by an α2-adrenergic receptor agonist (medetomidine) were initially used for veterinary anesthesia. Receives: Drug: Dexmedetomidine |
| group CONTROL | Placebo comparator | normal saline 0.9 % Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of POCD
determined by The mini-mental state examination( range from 0 to 30 , scores > 25 interpreted as normal cognitive status) score mini-cog score Richmond Agitation Sedation Scale(range from +4 to -5 , score 0 signifies a calm and alert patient ) .
Measured: 24-72 hours postoperatively
the incidence of post operative cognitive dysfunction
determined by The mini-mental state examination score at post operative day 1 ,post operative day 3 scores >25 interpreted as normal cognitive status.
Measured: change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start23 Dec 2024
- Primary completion23 Apr 2025
- Study completion23 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive Function of Elderly PatientsStudies of the same condition, open and under way.
- More trials run by Benha 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patiants will randomly assigned into 3 groups : lidocaine group , dexmedetomidene group , control group ( receive normal saline).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Sobhy Mohamed, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497009
- Sponsor's protocol ID
- Ms.66.12.2024
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lidocine Infusion Versus Dexmedemidane Infusion on the Neurocognitive Function of Elderly Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP).
- ClinicalTrials.gov ID
- NCT07497009
- Acronym / sponsor ID
- Ms.66.12.2024
- Keywords
- neurocognitive function, POCD, Dexmedetomidine, lidocaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 23 Aug 2025 (actual)
- First posted
- 27 Mar 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.
dexmedetomidine infusion or lidocaine infusion starting before induction of intravenous general anesthesia and continue as infusion intraoperative can reduce postoperative cognitive dysfunction incidence (primary outcome), postoperative cognitive dilirium, postoperative pain, opioid consumption, postoperative inflammatory response and postoperative adverse events (secondary outcomes) in elderly patients undergoing ERCP.
Detailed description
Randomization will be achieved using a computer-generated random sequence, and group allocation will be concealed using opaque, sealed envelopes. Both patients and study staff, including those administering the interventions and assessing outcomes will be blinded to the group assignments. The tested syringes will be prepared by the responsible nurse in equal volumes of 50 ml. All data of the patients will be confidential with secret codes and private file for each patient, all given data will be used for the current medical research only.
The prefilled 50 mL syringes will contain either dexmedetomidine 4 µg/mL or lidocaine 10 mg/mL or NaCl 0.9%. Ten minutes before anesthesia induction all patients will receive an IV infusion at a rate of 0.9mL/kg/h for 10 minutes. This rate corresponds to 0.6 µg/kg dexmedetomidine or 1.5 mg/kg lidocaine. Afterwards, all patients will receive an infusion at a rate of 0.15mL/kg/h until the end of procedure; this rate corresponds to 1.5 mg/kg/h of lidocaine or 0.6 µg/kg/h of dexmedetomidine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- patiants will randomly assigned into 3 groups : lidocaine group , dexmedetomidene group , control group ( receive normal saline).
| Arm | Type | Receives |
|---|---|---|
| group LIDO | Active comparator | Drug: lidocaineSimilar to other local anesthetics, lidocaine acts at sodium ion channels on the internal surface of nerve cell membranes. The uncharged form of lidocaine diffuses through neural sheaths into the axoplasm before ionizing by combining with hydrogen ions. The resulting cation binds reversibly to sodium channels from the inside, locking them in the open state and preventing nerve depolarization. |
| group DEX | Experimental | Drug: DexmedetomidineThe sedative and analgesic effects induced by an α2-adrenergic receptor agonist (medetomidine) were initially used for veterinary anesthesia. |
| group CONTROL | Placebo comparator | Drug: normal salinenormal saline 0.9 % |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
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 |
|---|---|---|
| DexmedetomidineAlso: precedexpatients will receive 0.6 µg/kg dexmedetomidine bolus 10 min before induction then it will be infused intravenously at a rate of 0.6 μg/Kg/h. until end of surgery. | Drug | group DEX |
| lidocaineAlso: xylocainepatients will be received 1.5 mg/kg lidocaine bolus 10min before induction of anaesthesia, followed by continuous infusion at a rate of 1.5 mg/Kg/h until end of surgery. | Drug | group LIDO |
| normal salineAlso: 0.9% sodium chloridepatients will receive 0.9% isotonic saline bolus followed by IV infusion at a rate of 0.9 ml/Kg/h till the end of surgery. | Drug | group CONTROL |
Primary outcome
The incidence of POCD
Time frame: 24-72 hours postoperatively
determined by The mini-mental state examination( range from 0 to 30 , scores > 25 interpreted as normal cognitive status) score mini-cog score Richmond Agitation Sedation Scale(range from +4 to -5 , score 0 signifies a calm and alert patient ) .
the incidence of post operative cognitive dysfunction
Time frame: change from baseline at 12 weeks
determined by The mini-mental state examination score at post operative day 1 ,post operative day 3 scores >25 interpreted as normal cognitive status.
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 31 Mar 2026.
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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 Dexmedetomidine, lidocaine and normal saline in people with Neurocognitive Function of Elderly Patients, run by Benha 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?
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 31 Mar 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?
The incidence of POCD (time frame: 24-72 hours postoperatively). The study lists 2 primary outcomes in all. 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 31 Mar 2026.