Cognitive Dysfunction, PostoperativePhase 2NCT04634656
Lidocaine on Early Cognitive Dysfunction in Shoulder Arthroscopy
A Phase 2 study testing Lidocaine and Normal saline in people with Cognitive Dysfunction, Postoperative, run by Assiut University at 1 site in Egypt.
Trial summary
The beach chair position (BCP) combined with deliberate hypotension impair cerebral perfusion pressure and oxygenation during arthroscopic shoulder surgeries and produce cerebral ischemia. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Cognitive Dysfunction, Postoperative
- What is being tested?
- 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
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jan 2021to 10 Nov 2021
- Phase
- Phase 2
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective arthroscopic shoulder surgery under general anesthesia in beach chair position (BCP),
- Age 20 to 65 years old.
Who cannot join
- Mini-Mental State Examination (MMSE) score < 23 before surgery
- History of neurological disease (such as previous episodes of cerebral ischemia or stroke).
- History of psychological disorder
- Suspected history of adverse reactions to lidocaine
- Drug or alcohol abuse
- History of diabetes mellitus, sever hypertension, severe anemia, hepatic or renal dysfunction
- Unwillingness to comply with protocol.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Seham Mohamed Moeen
Asyut, Asyut Governorate, 71515
Seham M Moeen, MD, 01006386324 ext. 02, seham.moeen@yahoo.com
About this study
Official title: Neuroprotective Effects of Lidocaine on Early Postoperative Cognitive Dysfunction in Patients Undergoing Shoulder Arthroscopy With Beach Chair Position: a Randomized Trial
The beach chair position (BCP) combined with deliberate hypotension impair cerebral perfusion pressure and oxygenation during arthroscopic shoulder surgeries and produce cerebral ischemia.
Read the detailed description
Arthroscopic diagnosis and treatment of shoulder disorders have replaced open procedure as the primary treatment method. The beach chair (BCP) and lateral decubitus (LDP) positions are both considered as reliable techniques for performing effective arthroscopic shoulder surgeries. The usage of BCP for shoulder arthroscopic operations started from early 1980s.
The advantages of BCP include lack of brachial plexus strain, good intra-articular visualization, with the ease of conversion to an open approach if required.
The BCP combined with deliberate hypotension has been used to decrease intraoperative blood loss and allow a relatively blood-free surgical field. However, this combination has the risk to impair cerebral perfusion pressure and oxygenation during surgery and produce cerebral ischemia.
Lidocaine, a commonly used local anesthetic and class IB antiarrhythmic drug, that readily crosses the blood - brain barrier. Evans et al. initially reported cerebral protection of lidocaine in a feline model of cerebral arterial gas embolism. Later on, the effects of lidocaine on perioperative neuroprotection were detected. However, the mechanisms underlying lidocaine treatment-induced neuroprotection remain incompletely understood.
Lidocaine may provide cerebral protection through many mechanisms, including decreasing the cerebral metabolic rate, decelerating the ischemic transmembrane ion shift, and reducing the ischemic excitotoxin release.
- Conditions
- Cognitive Dysfunction, Postoperative
- Being tested
- Lidocaine, Normal saline
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Xylocaine
Patients will receive lidocaine in a loading dose of 1 mg/ kg diluted in 10 ml of normal saline that will be infused over 5 minutes after induction of anesthesia then followed by a continuous infusion at 1.5 mg/ kg/ h diluted in normal saline to a volume of 50 ml until the end of surgery
Normal salineDrug
Patients will receive normal saline after induction of anesthesia with the same volume and rate changes as lidocaine group until the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| Group L | Active comparator | Patients will receive lidocaine in a loading dose of 1 mg/ kg diluted in 10 ml of normal saline that will be infused over 5 minutes after induction of anesthesia then followed by a continuous infusion at 1.5 mg/ kg/ h diluted in normal saline to a volume of 50 ml until the end of surgery. Receives: Drug: Lidocaine |
| Group C | Placebo comparator | Patients will receive normal saline after induction of anesthesia with the same volume and rate changes as lidocaine group until the end of surgery. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative cognitive function
Assessed using Mini-Mental State Examination (MMSE) test
Measured: 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start7 Jan 2021
- Primary completion10 Nov 2021 (estimated)
- Study completion10 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Dysfunction, PostoperativeStudies of the same condition, open and under way.
- More trials run by Assiut 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seham Mohamed Moeen Ibrahim, Assiut University
- Investigators
- Seham M Moeen, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634656
- Sponsor's protocol ID
- SM 2020
- Status last verified
- Jan 2021
- First submitted
- 12 Nov 2020
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroprotective Effects of Lidocaine on Early Postoperative Cognitive Dysfunction in Patients Undergoing Shoulder Arthroscopy With Beach Chair Position: a Randomized Trial
- ClinicalTrials.gov ID
- NCT04634656
- Acronym / sponsor ID
- SM 2020
- Conditions
- Cognitive Dysfunction, Postoperative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 10 Nov 2021 (estimated)
- Study completion
- 10 Nov 2021 (estimated)
- First posted
- 18 Nov 2020 (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.
The beach chair position (BCP) combined with deliberate hypotension impair cerebral perfusion pressure and oxygenation during arthroscopic shoulder surgeries and produce cerebral ischemia.
Detailed description
Arthroscopic diagnosis and treatment of shoulder disorders have replaced open procedure as the primary treatment method. The beach chair (BCP) and lateral decubitus (LDP) positions are both considered as reliable techniques for performing effective arthroscopic shoulder surgeries. The usage of BCP for shoulder arthroscopic operations started from early 1980s.
The advantages of BCP include lack of brachial plexus strain, good intra-articular visualization, with the ease of conversion to an open approach if required.
The BCP combined with deliberate hypotension has been used to decrease intraoperative blood loss and allow a relatively blood-free surgical field. However, this combination has the risk to impair cerebral perfusion pressure and oxygenation during surgery and produce cerebral ischemia.
Lidocaine, a commonly used local anesthetic and class IB antiarrhythmic drug, that readily crosses the blood - brain barrier. Evans et al. initially reported cerebral protection of lidocaine in a feline model of cerebral arterial gas embolism. Later on, the effects of lidocaine on perioperative neuroprotection were detected. However, the mechanisms underlying lidocaine treatment-induced neuroprotection remain incompletely understood.
Lidocaine may provide cerebral protection through many mechanisms, including decreasing the cerebral metabolic rate, decelerating the ischemic transmembrane ion shift, and reducing the ischemic excitotoxin release.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group L | Active comparator | Drug: LidocainePatients will receive lidocaine in a loading dose of 1 mg/ kg diluted in 10 ml of normal saline that will be infused over 5 minutes after induction of anesthesia then followed by a continuous infusion at 1.5 mg/ kg/ h diluted in normal saline to a volume of 50 ml until the end of surgery. |
| Group C | Placebo comparator | Drug: Normal salinePatients will receive normal saline after induction of anesthesia with the same volume and rate changes as lidocaine group until the end of surgery. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing elective arthroscopic shoulder surgery under general anesthesia in beach chair position (BCP),
- Age 20 to 65 years old.
Key exclusion criteria (7 listed)
- Mini-Mental State Examination (MMSE) score < 23 before surgery
- History of neurological disease (such as previous episodes of cerebral ischemia or stroke).
- History of psychological disorder
- Suspected history of adverse reactions to lidocaine
- Drug or alcohol abuse
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 |
|---|---|---|
| LidocaineAlso: XylocainePatients will receive lidocaine in a loading dose of 1 mg/ kg diluted in 10 ml of normal saline that will be infused over 5 minutes after induction of anesthesia then followed by a continuous infusion at 1.5 mg/ kg/ h diluted in normal saline to a volume of 50 ml until the end of surgery | Drug | Group L |
| Normal salinePatients will receive normal saline after induction of anesthesia with the same volume and rate changes as lidocaine group until the end of surgery | Drug | Group C |
Primary outcome
Postoperative cognitive function
Time frame: 3 days after surgery
Assessed using Mini-Mental State Examination (MMSE) test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
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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.
Seham M Moeen, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine and Normal saline in people with Cognitive Dysfunction, Postoperative, run by Assiut 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Jan 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seham M Moeen, MD (01006386324 ext. 02, seham.moeen@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative cognitive function (time frame: 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 8 Jan 2021.