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This study is designed as a population-based prospective randomized cohort study. A prospective cohort of patients admitted to laparoscopic sleeve gastrectomy due to morbid obesity
All adult consecutive patients admitted to surgical departments for laparoscopic sleeve gastrectomy will be enrolled prospectively.
For the purposes of the current study we want to determine how much paracetamol (acetaminophen) can reduce the cytokines levels in these patients
The study enrollment period is planned to be a year. The follow-up period for each patient will be until discharge from the hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV paracetamol | Experimental | Patients in the first group will receive in the operating room before surgery 1 gram (100 ml) of intravenous paracetamol ( IV paracetamol) for 15 minutes intraoperative |
|
| IV saline (NaCl 0.9 %) | Placebo Comparator | Patients in the second group will receive 100 mL NACL 0.9% (IV NaCl 0.9 %)intraoperative |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV paracetamol | Drug | 100 gram paracetamol infusion for moderate pain management |
|
| Measure | Description | Time Frame |
|---|---|---|
| measuring of Visual Analogue pain Scale, | Visual Analogue pain Scale to determine patient level of pain , for establish the correct timing of paracetamol administration | up to 48 hours after surgery |
| measuring of Cytokine levels | measuring of Cytokine levels in comparison of timing of paracetamol administration , as a predictor for inflammatory mediators released in response to noxious stimuli | up to 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total consumption of opiates after surgery | post - operative opioid consumption in manner of dosage and frequency in ward | up to 72 hours after surgery |
| Respiratory post-operative complication while in ward |
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Inclusion Criteria:
Exclusion Criteria:
Drug addict
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yair Binyamin, MD | Contact | +972586963871 | Yairben1@gmail.com | |
| Yair Yaish Reina, MD | Contact | +972545442655 | yair0026@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael Semionov, MD | Soroka University Medical Center-Department of Anesthesiology | Study Director |
| Alexander Zlotnic, PhdMD | Soroka University Medical Center-Department of Anesthesiology | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27177956 | Background | Ruiz-Tovar J, Munoz JL, Gonzalez J, Zubiaga L, Garcia A, Jimenez M, Ferrigni C, Duran M. Postoperative pain after laparoscopic sleeve gastrectomy: comparison of three analgesic schemes (isolated intravenous analgesia, epidural analgesia associated with intravenous analgesia and port-sites infiltration with bupivacaine associated with intravenous analgesia). Surg Endosc. 2017 Jan;31(1):231-236. doi: 10.1007/s00464-016-4961-3. Epub 2016 May 13. | |
| 23054575 |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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This study is designed as a population-based prospective randomized cohort study. A prospective cohort of patients admitted to laparoscopic sleeve gastrectomy due to morbid obesity
Not provided
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| IV saline (NaCl 0.9 %) | Drug | 100 ml of Normal Saline (IV NaCl 0.9 %) as placebo |
|
|
Respiratory complication (need of respiratory support, need of intensive care unit hospitalization)
| up to 72 hours after surgery |
| septic post-operative complication while in ward | development of fever above 38° C | up to 72 hours after surgery |
| Cardiovascular post-operative complication while in ward | Cardiovascular complication (hemodynamic instability, inotropic support ) | up to 72 hours after surgery |
| Gastrointestinal post-operative complication while in ward | Gastrointestinal complaints as nausea and vomiting, need to use antiemetic drug | up to 72 hours after surgery |
| urinary trak post-operative complication while in ward | Incidence of urinary retention and need for catheterization | up to 72 hours after surgery |
| post-operative pruritus while in ward | Pruritus | up to 72 hours after surgery |
| post-operative hospitalization | length of hospital stay by number of days | up to one week after surgery |
| Respiratory post-operative complication while recovering in post anesthesia care unit | Respiratory complication need of respiratory support, need of intensive care unit hospitalization) | up to 5 hours after surgery |
| septic post-operative complication while recovering in post anesthesia care unit | Development of fever above 38° C | up to 5 hours after surgery |
| Cardiovascular post-operative complication while recovering in post anesthesia care unit | Cardiovascular complication (hemodynamic instability, inotropic support ) | up to 5 hours after surgery |
| Gastrointestinal post-operative complication while recovering in post anesthesia care unit | Gastrointestinal complication as nausea and vomiting, need to use antiemetic drugs | up to 5 hours after surgery |
| urinary retention post-operative complication while recovering in post anesthesia care unit | incience of urinary retention and need for catheterization | up to 5 hours after surgery |
| post-operative pruritus while recovering in post anesthesia care unit | Pruritus | up to 5 hours after surgery |
| post-operative stay in post anesthesia care unit | length of post anesthesia care unit stay by number of hours | up to 5 hours after surgery |
| Yair Binyamin, MD | Soroka University Medical Center-Department of Anesthesiology | Principal Investigator |
| Yair Yaish Reina, MD | Soroka University Medical Center-Department of Anesthesiology | Principal Investigator |
| Result |
| Salihoglu T, Salihoglu Z, Zengin AK, Taskin M, Colakoglu N, Babazade R. The impacts of super obesity versus morbid obesity on respiratory mechanics and simple hemodynamic parameters during bariatric surgery. Obes Surg. 2013 Mar;23(3):379-83. doi: 10.1007/s11695-012-0783-0. |
| 23011043 | Result | Rieg AD, Stoppe C, Rossaint R, Coburn M, Hein M, Schalte G. [EzPAP(R) therapy of postoperative hypoxemia in the recovery room : experiences with the new compact system of end-expiratory positive airway pressure]. Anaesthesist. 2012 Oct;61(10):867-74. doi: 10.1007/s00101-012-2083-4. Epub 2012 Sep 27. German. |
| 22833138 | Result | Cullen A, Ferguson A. Perioperative management of the severely obese patient: a selective pathophysiological review. Can J Anaesth. 2012 Oct;59(10):974-96. doi: 10.1007/s12630-012-9760-2. Epub 2012 Jul 26. |
| 22250276 | Result | Aubrun F, Mazoit JX, Riou B. Postoperative intravenous morphine titration. Br J Anaesth. 2012 Feb;108(2):193-201. doi: 10.1093/bja/aer458. |
| 21823370 | Result | Macintyre PE, Loadsman JA, Scott DA. Opioids, ventilation and acute pain management. Anaesth Intensive Care. 2011 Jul;39(4):545-58. doi: 10.1177/0310057X1103900405. |
| 21516915 | Result | Schug SA, Raymann A. Postoperative pain management of the obese patient. Best Pract Res Clin Anaesthesiol. 2011 Mar;25(1):73-81. doi: 10.1016/j.bpa.2010.12.001. |
| 21252836 | Result | Daszkiewicz A, Wylezol M. Postoperative analgesia in a morbidly obese patient with chronic renal failure. Anestezjol Intens Ter. 2010 Oct-Dec;42(4):197-200. |
| 21224800 | Result | Ahmed S, Morrow E, Morton J. Perioperative considerations when operating on the very obese: tricks of the trade. Minerva Chir. 2010 Dec;65(6):667-75. |
| 20608558 | Result | Pelosi P, Gregoretti C. Perioperative management of obese patients. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):211-25. doi: 10.1016/j.bpa.2010.02.001. |
| 19961114 | Result | Hans GA, Lauwick S, Kaba A, Brichant JF, Joris JL. Postoperative respiratory problems in morbidly obese patients. Acta Anaesthesiol Belg. 2009;60(3):169-75. |
| 11748392 | Result | Bodian CA, Freedman G, Hossain S, Eisenkraft JB, Beilin Y. The visual analog scale for pain: clinical significance in postoperative patients. Anesthesiology. 2001 Dec;95(6):1356-61. doi: 10.1097/00000542-200112000-00013. |
| 21495003 | Result | Heinrich S, Horbach T, Salleck D, Birkholz T, Irouschek A, Schmidt J. [Perioperative anaesthesiological management in 167 patients undergoing bariatric surgery]. Zentralbl Chir. 2011 Dec;136(6):604-11. doi: 10.1055/s-0031-1271382. Epub 2011 Apr 14. German. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |