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Patients aged between 20 and 70 years, ASA physical status I-III, and scheduled for laparoscopic cholecystectomy under general anaesthesia will be enrolled in the study.
Patients will be randomized to the preemptive group to receive an antiemetic regime 1h before the start of surgery or to the intraoperative group to receive the same antiemetic drugs in the same doses intraoperatively, 30 min before the end of surgery.
In the operating room standard monitoring and a standardized anesthetic technique will be implemented in all patients. Nausea, vomiting, retching and PONV (cumulative) will be recorded at PACU, at 4h, 8h and 24h postoperatively. Pain scores assessed by NRS (numerical rating scale) will be recorded at the same time points. Also, when patients received fluids and solid food by mouth will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| preemptive group | Active Comparator | The preemptive group will receive the anti-emetic regimen i.v. (4 mg of ondansetron) 1h before the start of surgery. During surgery, 30 min before the end of operation, this group will receive i.v. 0.9% NaCl in equal volumes.The intervention consists of the different time points of antiemetic treatment, thus 1h before surgery vs intraopertively. Intervention: Antiemetic treatment 1h before surgery |
|
| intraoperative group | Other | The preventive group will receive i.v. 0.9% NaCl 1h before surgery and ondansetron 4 mg 30 min before the end of surgery at equal volumes. Intervention: Antiemetic treatment intraoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antiemetics perioperatively | Other | Preemptive group ondansetron 4 mg will be administered 1h before surgery Intraoperative group Ondansetron 4 mg will be administered intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| PONV (postoperative nausea vomiting combined) | Incidence of combined nausea and vomiting postoperatively | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative nausea frequency and intensity | numerical rating scale of nausea intensity (0-10) | 24 hours |
| postoperative vomiting frequency | number of vomits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Argyro Fassoulaki, MD PhD DEAA | Contact | 306936701333 | afassou1@otenet.gr | |
| Chryssoula Staikou, MD, PhD, DESA | Contact | 00306932352742 | c_staikou@yahoo.gr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aretaieio University Hospital | Athens | Attica | 11528 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25370136 | Background | Odom-Forren J, Rayens MK, Gokun Y, Jalota L, Radke O, Hooper V, Wiggins AT, Apfel CC. The Relationship of Pain and Nausea in Postoperative Patients for 1 Week After Ambulatory Surgery. Clin J Pain. 2015 Oct;31(10):845-51. doi: 10.1097/AJP.0000000000000170. | |
| 24356162 | Background | Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002. |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| 24 hours |
| postoperative pain | numerical rating scale of pain intensity (0-10) | 24 hours |
| retching | if retching exists | 24 hours |
| PONV (postoperative nausea vomiting combined) | frequency and intensity of nausea and vomiting | 24 hours |
| 23035051 | Background | Apfel CC, Heidrich FM, Jukar-Rao S, Jalota L, Hornuss C, Whelan RP, Zhang K, Cakmakkaya OS. Evidence-based analysis of risk factors for postoperative nausea and vomiting. Br J Anaesth. 2012 Nov;109(5):742-53. doi: 10.1093/bja/aes276. Epub 2012 Oct 3. |
| 22593126 | Background | Apfel CC, Meyer A, Orhan-Sungur M, Jalota L, Whelan RP, Jukar-Rao S. Supplemental intravenous crystalloids for the prevention of postoperative nausea and vomiting: quantitative review. Br J Anaesth. 2012 Jun;108(6):893-902. doi: 10.1093/bja/aes138. |
| 27270883 | Background | Wallden J, Flodin J, Hultin M. Validation of a prediction model for post-discharge nausea and vomiting after general anaesthesia in a cohort of Swedish ambulatory surgery patients. Eur J Anaesthesiol. 2016 Oct;33(10):743-9. doi: 10.1097/EJA.0000000000000473. |
| 37466110 | Derived | Theodosopoulou P, Staikou C, Fassoulaki A. Preoperative versus intraoperative antiemetic strategies in patients undergoing laparoscopic cholecystectomy: A randomised double-blind study. Eur J Anaesthesiol. 2023 Oct 1;40(10):769-776. doi: 10.1097/EJA.0000000000001888. Epub 2023 Jul 19. |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |