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| Name | Class |
|---|---|
| Egyptian Center for Research and Regenerative Medicine | OTHER_GOV |
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The goal of this observational study is to compare the effectiveness and patient satisfaction of local anesthesia combined with intravenous Dexmedetomidine versus epidural anesthesia in endoscopic lumbar discectomy surgeries
In recent years, with the development of medical instruments, minimally invasive surgical methods for lumbar disc herniation became increasingly popular, such as percutaneous transforaminal endoscopic discectomy (PTED) PTED under local anesthesia (LA) is recommended in consideration of safety. Under LA, patients keep conscious during the procedure, and the surgeon can obtain feedback directly from the patients if the nerve is interfered. However, in clinical practice, we found that many patients couldn't tolerate the pain during operation especially when placing the working channel Dexmedetomidine, a highly selective alpha 2 adrenoreceptor agonist, has unique characteristics in providing sedation and analgesia. Due to its central sympatholytic action, DEX produces dose-dependent sedation, antinociception and anxiolysis, while decreasing intraoperative hypertension and tachycardia episodes Epidural anesthesia is another major method which can keep patients awake during surgery and the surgeons can check the function of the nerve from the maintained motor function of patients' lower limbs
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexmedetomidine group | loading of Dexmedetomidine was done at a dose of 1 mcg/ kg over 10 minutes followed by continuous infusion at a rate of 0.5 mcg/kg/hr , followed by infiltration of the skin with 2-3 ml of lidocaine hydrochloride 1 % first by the surgeon then an 18 -G needle will be introduced to anesthetize the trajectory with 8-10 ml lidocaine 1 %. After reaching the superior articular process, 2-3 ml of lidocaine 1 % was used to anesthetize the facet joint. | ||
| Epidural group | The epidural insertion point was 2 segments upper than the surgical procedure, 10 ml of Bupivacaine 0.25% was injected in the epidural space to adjust the sensory level. The epidural catheter will be removed after 2 hours from the end of the operation |
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| Measure | Description | Time Frame |
|---|---|---|
| we compare numerical rating pain score (NRS) between the two groups immediately at foraminal dilatation maneuver | It refers to the common method used in healthcare where patients rate their pain on a scale from 0 to 10: 0 = No pain 10 = Worst pain imaginable. | from January 2021 to January 2024 |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate (H.R) | We compare the heart rate ( by beats per minute) in the 2 groups every 10 minutes intraoperative | from January 2021 to January 2024 |
| Mean arterial blood pressure (MABP) | we compare mean arterial blood pressure between the 2 groups by millimeter of mercury (mmhg) every 10 minutes intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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Patients are American Society of anesthesiologists' physical status (ASA) I to II aged 18 to 60 years of both sexes with clinical and radiological evidence of soft disc herniation in a single lumber segment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Medical Center | Cairo | Egypt |
"IPD will not be shared due to concerns regarding participant privacy, confidentiality, and regulatory limitations. In addition, appropriate consent for data sharing may not have been obtained from participants at the time of enrollment
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| from January 2021 to January 2024 |
| we compare Bromage scale in the two groups intraoperative during foraminal dilatation by the surgeon | It is a clinical tool used to assess motor function in the lower limbs following epidural or spinal anesthesia (from 0 to 3) 0 means full movement (no motor blockage) 3 means complete motor block - unable to move feet, legs, or raise leg. | from January 2021 to January 2024 |