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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
100 gram paracetamol infusion for moderate pain management
100 ml of Normal Saline (IV NaCl 0.9 %) as placebo
measuring of Visual Analogue pain Scale,
Visual Analogue pain Scale to determine patient level of pain , for establish the correct timing of paracetamol administration
Time frame: 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
Time frame: up to 48 hours after surgery
Total consumption of opiates after surgery
post - operative opioid consumption in manner of dosage and frequency in ward
Time frame: up to 72 hours after surgery
Respiratory post-operative complication while in ward
Respiratory complication (need of respiratory support, need of intensive care unit hospitalization)
Time frame: up to 72 hours after surgery
septic post-operative complication while in ward
development of fever above 38° C
Time frame: up to 72 hours after surgery
Cardiovascular post-operative complication while in ward
Cardiovascular complication (hemodynamic instability, inotropic support )
Time frame: up to 72 hours after surgery
Gastrointestinal post-operative complication while in ward
Gastrointestinal complaints as nausea and vomiting, need to use antiemetic drug
Time frame: up to 72 hours after surgery
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urinary trak post-operative complication while in ward
Incidence of urinary retention and need for catheterization
Time frame: up to 72 hours after surgery
post-operative pruritus while in ward
Pruritus
Time frame: up to 72 hours after surgery
post-operative hospitalization
length of hospital stay by number of days
Time frame: 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)
Time frame: up to 5 hours after surgery
septic post-operative complication while recovering in post anesthesia care unit
Development of fever above 38° C
Time frame: up to 5 hours after surgery
Cardiovascular post-operative complication while recovering in post anesthesia care unit
Cardiovascular complication (hemodynamic instability, inotropic support )
Time frame: 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
Time frame: 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
Time frame: up to 5 hours after surgery
post-operative pruritus while recovering in post anesthesia care unit
Pruritus
Time frame: 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
Time frame: up to 5 hours after surgery