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| ID | Type | Description | Link |
|---|---|---|---|
| 211198 | Registry Identifier | galal eldeen hasan hasan |
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The ongoing opioid crisis represents a significant public health challenge, with surgical prescriptions being a major contributor to chronic opioid use and misuse. Recent epidemiological data indicate that 4-6% of opioid- naïve patients develop persistent opioid use postoperatively, with laparoscopic cholecystectomy patients being particularly vulnerable due to moderate postoperative pain . Despite being a minimally invasive procedure, laparoscopic cholecystectomy consistently ranks among the most common general surgical procedures worldwide, with over 1 million performed annually in the United States alone. This frequency amplifies the population-level impact of postoperative prescribing patterns . Previous studies have demonstrated the efficacy of individual components-dexmedetomidine for hemodynamic stabilization, lidocaine infusions for visceral analgesia, and regional techniques like erector spinae plane (ESP) blocks-but their synergistic effects remain underexplored . A recent scoping review highlighted that while opioid-sparing (OS) effects are frequently reported, evidence for clinically meaningful outcomes (e.g., reduced ventilation time, accelerated functional recovery) remains limited . The pathophysiology of post-cholecystectomy pain involves both somatic (abdominal wall) and visceral (diaphragmatic irritation, biliary spasm) components, necessitating a multimodal approach. Opioids inadequately address inflammatory mediators while introducing risks of respiratory depression, postoperative nausea and vomiting (PONV), ileus, and hemodynamic instability. Emerging evidence suggests that α-2 agonists (e.g., dexmedetomidine) and NMDA ant
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OpioidSparingGroup OS) | Active Comparator |
| |
| ControlGroup (CG) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| opoid free anesthesia | Other | Maintenance Dexmedetomidine 0.2-0.5 µg/kg/h + Lidocaine 1.5 mg/kg/h + Magnesium 10 mg/kg/h; Sevoflurane as required; Atracurium 0.1 mg/kg IV PRN |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity at rest postoperatively (Visual Analog Scale, VAS, 0-10) | Pain intensity at rest will be measured using the Visual Analog Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain. | 48 hours post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative opioid use (MME) | Cumulative opioid consumption will be measured in morphine milligram equivalents (MME) administered to each patient. | 48 hours post operative |
| Time to extubating | Time to extubating; time to Aldrete ≥9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ola Mahmoud Wahba Gnedy, Assistant Prof. | Contact | 01151121981 | +2 | ola.genadi@med.aun.edu.eg |
| Mohamed Bakr Eid, prof | Contact | 01223213370 | +2 | bakr@aun.edu.eg |
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| Label | URL |
|---|---|
| Aldrete, J. A. (1995). The post-anesthesia recovery score revisited. Journal of Clinical Anesthesia, \*7\*(1), 89-91. | View source |
| .National Institutes of Health. HEAL Initiative: Preventing Opioid Use Disorder After Surgery. NIH Guide NOT-DA-22-052. 2022. | View source |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D020927 | Dexmedetomidine |
| D008274 | Magnesium |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Type of the study: Prospective, triple-blind, parallel-group, superiority block randomized controlled trial. Study Setting and design features.
• Allocation: Computer-generated 1:1 block randomization with allocation concealment (block size = 6), stratified by ASA status (I vs II/III).
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Blinding: Participants, anesthetist/ clinicians obserevers and data analysts will be blinded to group allocation.
|
| 24 hours post operative |
| Time to first rescue analgesia | time to first demand for rescue analgesia | 24 hours post operative |
| Bowel recovery (first flatus) | Time in hours from completion of surgery until the patient passes first flatus, representing bowel recovery. | 48 hours post operative |
| Ambulation tolerance | Assessment of the patient's ability to ambulate, measured as distance walked in feet or meters within specified postoperative periods. | 48 hours post operative |
| . Huskisson, E. C. (1974). Measurement of pain. The Lancet, \*304\*(7889), 1127-1131. | View source |
| Aniline Compounds |
| D000588 | Amines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |