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| ID | Type | Description | Link |
|---|---|---|---|
| 6476# | Registry Identifier | Research Ethics Committee, Faculty of Medicine, Suez Canal University |
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Intraoperative hypotension is commonly treated with fluid administration; however, excessive fluid therapy may contribute to postoperative pulmonary complications. This randomized double-blind controlled trial evaluates whether proactive administration of fixed low-dose norepinephrine reduces intraoperative crystalloid administration while maintaining hemodynamic stability in high-risk patients undergoing laparoscopic abdominal surgery. One hundred and thirty patients will be randomized to receive either norepinephrine infusion (0.03 µg/kg/min) or placebo from induction until skin closure within a protocolized hemodynamic strategy guided by mean arterial pressure and pulse pressure variation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Norepinephrine Group | Experimental | Participants will receive continuous norepinephrine infusion at a fixed dose of 0.03 µg/kg/min initiated immediately after induction of anesthesia and continued until skin closure within a protocolized hemodynamic management strategy. |
|
| Control Group | Placebo Comparator | Participants will receive an equivalent volume normal saline infusion initiated immediately after induction of anesthesia and continued until skin closure within the same protocolized hemodynamic management strategy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norepinephrine | Drug | Continuous norepinephrine infusion administered at a fixed dose of 0.03 µg/kg/min from induction of anesthesia until skin closure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total intraoperative crystalloid administration | Total volume of crystalloid administered intraoperatively from induction of anesthesia until skin closure, measured in milliliters. | From induction of anesthesia until skin closure (intraoperative period) |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pulmonary Complications | Incidence of postoperative pulmonary complications defined according to European Perioperative Clinical Outcome (EPCO) criteria using clinical, radiological, and laboratory findings | Within seven postoperative days |
| Acute Kidney Injury |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammad Elhossieny Salama, MD | Contact | +201016865861 | MohammadElhossieny88@med.suez.edu.eg | |
| Mahmoud Hosny Ahmed, MD | Contact | +201097920831 | M.hosnawy@med.suez.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suez Canal University Hospitals | Ismailia | Ismailia Governorate | 41522 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35610620 | Result | Persichini R, Lai C, Teboul JL, Adda I, Guerin L, Monnet X. Venous return and mean systemic filling pressure: physiology and clinical applications. Crit Care. 2022 May 24;26(1):150. doi: 10.1186/s13054-022-04024-x. | |
| 40778974 | Result | Felippe VA, Codeceira R, Irigaray M, Sckaff M, Wegner B, Nascimento T, Darcy C, Dutra L, Santiago B, Buchmann J, Lessa MA. Non-invasive goal-directed fluid therapy with the pleth variability index (PVI): a systematic review and meta-analysis. J Clin Monit Comput. 2025 Oct;39(5):917-927. doi: 10.1007/s10877-025-01334-7. Epub 2025 Aug 8. |
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| Placebo | Other | Equivalent volume normal saline infusion administered from induction of anesthesia until skin closure at the same infusion rate as the active intervention to maintain blinding within a protocolized hemodynamic management strategy. |
|
Incidence of acute kidney injury defined according to KDIGO criteria based on serum creatinine changes and urine output. |
| Within seven postoperative days |
| Lactate Levels | Arterial lactate concentration measured in mmol/L serially during the perioperative period | After induction of anesthesia, at the end of surgery, and 24 hours postoperatively |
| Urine Output | Hourly intraoperative urine output measured from urinary catheter collection and expressed as total mL/kg/hour. | From induction of anesthesia until skin closure (Intraoperative period) |
| Intraoperative Blood Loss | Estimated intraoperative blood loss measured in milliliters using suction canister volume after subtraction of irrigation fluids in addition to surgical field assessment. | From surgical incision until skin closure (Intraoperative period) |
| Rescue Norepinephrine Requirement | Requirement for rescue open-label norepinephrine infusion for persistent hemodynamic instability including cumulative duration of infusion measured in minute | From induction of anesthesia until skin closure (Intraoperative period) |
| Duration of Intraoperative Hypotension | Cumulative duration of intraoperative hypotension defined as mean arterial pressure below 65 mmHg, measured in minutes and recorded from invasive arterial blood pressure monitoring. | From induction of anesthesia until skin closure (Intraoperative period) |
| Intensive Care Unit Admission | Admission to the intensive care unit during the postoperative period. | Within seven postoperative days |
| Length of Hospital Stay | Total postoperative hospital stay measured in days during the first seven postoperative days | Within seven postoperative days |
| Postoperative Surgical Complications | Incidence of postoperative surgical complications assessed according to Clavien-Dindo classification grade II or higher during the first seven postoperative days. | Within seven postoperative days |
| 26162676 | Result | Cecconi M, Hofer C, Teboul JL, Pettila V, Wilkman E, Molnar Z, Della Rocca G, Aldecoa C, Artigas A, Jog S, Sander M, Spies C, Lefrant JY, De Backer D; FENICE Investigators; ESICM Trial Group. Fluid challenges in intensive care: the FENICE study: A global inception cohort study. Intensive Care Med. 2015 Sep;41(9):1529-37. doi: 10.1007/s00134-015-3850-x. Epub 2015 Jul 11. |
| 21045639 | Result | Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a. |
| 21705869 | Result | Cannesson M, Le Manach Y, Hofer CK, Goarin JP, Lehot JJ, Vallet B, Tavernier B. Assessing the diagnostic accuracy of pulse pressure variations for the prediction of fluid responsiveness: a "gray zone" approach. Anesthesiology. 2011 Aug;115(2):231-41. doi: 10.1097/ALN.0b013e318225b80a. |
| 29742967 | Result | Myles PS, Bellomo R, Corcoran T, Forbes A, Peyton P, Story D, Christophi C, Leslie K, McGuinness S, Parke R, Serpell J, Chan MTV, Painter T, McCluskey S, Minto G, Wallace S; Australian and New Zealand College of Anaesthetists Clinical Trials Network and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery. N Engl J Med. 2018 Jun 14;378(24):2263-2274. doi: 10.1056/NEJMoa1801601. Epub 2018 May 9. |
| ID | Term |
|---|---|
| D009638 | Norepinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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