A Phase 2 interventional study of Lidocaine and Normal saline in Cognitive Dysfunction, Postoperative, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-01-08.
Sponsored by Assiut University · Phase 2, Interventional, and Prevention
The beach chair position (BCP) combined with deliberate hypotension impair cerebral perfusion pressure and oxygenation during arthroscopic shoulder surgeries and produce cerebral ischemia.
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.
264 studies on the registry are indexed under Postoperative Cognitive Complications; 54 are open to participants now.
This study's planned enrollment of 80 is below the median of 110 across 147 interventional studies indexed under Postoperative Cognitive Complications.
Browse Postoperative Cognitive Complications studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
Drug: Lidocaine
Patients will receive normal saline after induction of anesthesia with the same volume and rate changes as lidocaine group until the end of surgery.
Drug: Normal saline
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
Also known as: Xylocaine
Patients will receive normal saline after induction of anesthesia with the same volume and rate changes as lidocaine group until the end of surgery
Postoperative cognitive function
Assessed using Mini-Mental State Examination (MMSE) test
Time frame: 3 days after surgery
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Postoperative Cognitive Complications→
Assiut University