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The use of antioxidant agents in the prevention or decreasing the severity of postoperative systemic inflammatory response syndrome after colonic surgeries adopted nowadays. Therefore, it is of interest to investigate safety and efficacy of administrating short term intravenous (IV) N acetyl cysteine as add on to l alany l glutamine and total parenteral nutrition on the marker of oxidative stress malondialdehyde and anti- inflammatory marker tumor necrosis factor alpha in patients undergoing colonic surgeries through a prospective, randomized, double blinded, controlled clinical trial
A prospective, randomized, double blinded, controlled clinical trial will be carried out on 60 patients, who will admit to the critical care unit, Ain Shams hospitals, Cairo, Egypt, following colon surgeries. Before the start of the study, eligible patients were randomized using computer generated list in order to allocate participants to either Group I (n acetyl cysteine group) or Group II (control group) in an equal manner No medication will take before the surgery and only oral fluids were allowed on the day before the operation. All eligible patients underwent bowel preparation with oral 1.745 g/ 30 ml magnesium citrate, and phosphate containing enema on the day before surgery. All patients received the general anesthesia with endotracheal intubation and muscle relaxant.
Data management and analysis were performed using the Statistical Package for Social Sciences (SPSS) software for Windows version 18
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N acetylcysteine group | Active Comparator | N Acetyl L Cysteine IV bolus (100 mg/kg dissolved in dextrose5%) infused over 15 minutes, followed by continuous infusion of 50mg/kg/day dissolved in dextrose 5% starting 1hr before induction of anesthesia, and continued for 48 hours after operation |
|
| placebo group | Placebo Comparator | received equal volume of dextrose 5% administrated at the same rate and duration as in the study group as a placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N Acetyl L Cysteine | Drug | 100 mg/kg n acetyl cysteine dissolved in dextrose5% |
| |
| Measure | Description | Time Frame |
|---|---|---|
| assessing a change in the level of tumor necrosis factor alpha (TNF alpha) as ant-inflammatory marker reflecting n acetyl cysteine efficacy | TNF alpha was measured using ELISA technique | Venous blood samples were obtained before surgery (baseline evaluation), and on day two after surgery for measuring changes in TNF ALPHA |
| assessing a change in the level of malondialdehyde as antioxidant marker in the venous blood sample reflecting n acetyl cysteine efficacy | malondialdehyde was measured using colorimetric method for assay | Venous blood samples were obtained before surgery (baseline evaluation), and on day two after surgery for measuring changes in malondialdehyde level |
| Measure | Description | Time Frame |
|---|---|---|
| measuring safety of N acetyl cysteine (adverse effects) | recording any adverse effects that may appear | from the beginning of the study till the patient is discharged from the hospital(up to one week) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| manal elhammsy, prof | Ain Shams University , faculty of pharmacy | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31381364 | Derived | Hamamsy ME, Bondok R, Shaheen S, Eladly GH. Safety and efficacy of adding intravenous N-acetylcysteine to parenteral L-alanyl-L-glutamine in hospitalized patients undergoing surgery of the colon: a randomized controlled trial. Ann Saudi Med. 2019 Jul-Aug;39(4):251-257. doi: 10.5144/0256-4947.2019.251. Epub 2019 Aug 5. |
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All the individual participant data will be stored on the computer and will be available on request only
it will be available once the trial ends, and for 3 months after publication
data will be available on request
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| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| dextrose 5% |
| Other |
|
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |