Obesity, Morbid
Conditions
Keywords
morbidly obese, ,elective sleeve, gastrectomy, paracetamol, IV Perfelgan
Brief summary
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
Detailed description
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.
Interventions
DRUGIV paracetamol
100 gram paracetamol infusion for moderate pain management
DRUGIV saline (NaCl 0.9 %)
100 ml of Normal Saline (IV NaCl 0.9 %) as placebo
Sponsors
Soroka University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Age ≥18 years * Patients admitted for laparoscopic sleeve gastrectomy * Elective surgery * BMI \> 40 * American Society of Anesthesiology Classification: 1-2
Exclusion criteria
* Patients' refusal to participate in the study * Patients unable to give an informed consent * Pregnancy * Emergency surgery * Patient with known allergy to paracetamol * Patient with hepatic failure * international normalized ratio \>1.7 * Albumin\<3.5g/Dl * Bilirubin \>2mg/dL * Patient with fever \> 37.5 ° C * Patient with hemoglobin \< 8 * Patients chronically treated with steroids or steroid-treated patients over a month in the year preceding surgery. Drug addict
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| measuring of Visual Analogue pain Scale, | up to 48 hours after surgery | Visual Analogue pain Scale to determine patient level of pain , for establish the correct timing of paracetamol administration |
| measuring of Cytokine levels | up to 48 hours after surgery | measuring of Cytokine levels in comparison of timing of paracetamol administration , as a predictor for inflammatory mediators released in response to noxious stimuli |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| septic post-operative complication while in ward | up to 72 hours after surgery | development of fever above 38° C |
| Cardiovascular post-operative complication while in ward | up to 72 hours after surgery | Cardiovascular complication (hemodynamic instability, inotropic support ) |
| Gastrointestinal post-operative complication while in ward | up to 72 hours after surgery | Gastrointestinal complaints as nausea and vomiting, need to use antiemetic drug |
| urinary trak post-operative complication while in ward | up to 72 hours after surgery | Incidence of urinary retention and need for catheterization |
| post-operative pruritus while in ward | up to 72 hours after surgery | Pruritus |
| post-operative hospitalization | up to one week after surgery | length of hospital stay by number of days |
| Total consumption of opiates after surgery | up to 72 hours after surgery | post - operative opioid consumption in manner of dosage and frequency in ward |
| septic post-operative complication while recovering in post anesthesia care unit | up to 5 hours after surgery | Development of fever above 38° C |
| Cardiovascular post-operative complication while recovering in post anesthesia care unit | up to 5 hours after surgery | Cardiovascular complication (hemodynamic instability, inotropic support ) |
| Gastrointestinal post-operative complication while recovering in post anesthesia care unit | up to 5 hours after surgery | Gastrointestinal complication as nausea and vomiting, need to use antiemetic drugs |
| urinary retention post-operative complication while recovering in post anesthesia care unit | up to 5 hours after surgery | incience of urinary retention and need for catheterization |
| post-operative pruritus while recovering in post anesthesia care unit | up to 5 hours after surgery | Pruritus |
| post-operative stay in post anesthesia care unit | up to 5 hours after surgery | length of post anesthesia care unit stay by number of hours |
| Respiratory post-operative complication while recovering in post anesthesia care unit | up to 5 hours after surgery | Respiratory complication need of respiratory support, need of intensive care unit hospitalization) |
| Respiratory post-operative complication while in ward | up to 72 hours after surgery | Respiratory complication (need of respiratory support, need of intensive care unit hospitalization) |
Contacts
Primary ContactYair Binyamin, MD
Backup ContactYair Yaish Reina, MD
Outcome results
None listed