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Patients planned for laparoscopic cholecystectomy will be included in this study. The effects of liberal and restrictive fluid regimens given peroperatively to patients undergoing laparoscopic cholecystectomy will be compared on postoperative nausea and vomiting. The aim of this study is to investigate which regimen is more effective on postoperative nausea and vomiting in laparoscopic cholecystectomy.
Postoperative nausea and vomiting (PONV) is a common and disturbing side effect of anesthesia and surgery, and while its incidence in all surgical procedures varies between 20-77% if antiemetic prophylaxis is not applied, this rate is even higher in people prone to vomiting, such as cyclic vomiting syndrome . Its incidence varies between 53 - 72%, especially in patients undergoing laparoscopic cholecystectomy surgery, if antiemetic prophylaxis is not administered.
Since most existing antiemetics are expensive and cannot completely eliminate PONV, pharmacological PONV prophylaxis may not be cost-effective. For this reason, the incidence of PONV can be reduced by increasing the amount of inexpensive fluid used during surgery instead of prophylactic drug treatment. There are several studies investigating the effect of different perioperative fluid administration schemes on PONV in the adult population, especially in patients undergoing laparoscopic cholecystectomy or gynecological surgery, with variable results.
Based on this point, the inestigetors wanted to examine the effect of perioperative liberal and restrictive fluid treatments on PONV in patients who underwent laparoscopic cholecystectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liberal Fluid Group | Active Comparator | Patients in this group will be administered 20 mL/kg/h ringer lactate intravenously peroperatively. |
|
| Restrictive Fluid Group | Sham Comparator | Patients in this group will be administered 4 mL/kg/h ringer lactate intravenously peroperatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liberal Fluid Grubu | Other | Patients in this group will be administered 20 mL/kg/h ringer lactate intravenously peroperatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative nausea-vomiting | Incidence of nausea and vomiting within 24 hours after surgery. The presence of at least one episode of nausea, retching and vomiting in the first 24 hours postoperatively will be considered a positive result. | Postoperative 24 hours |
| Quality of recovery | Quality of recovery will be evaluated at the 24th hour using the QoR-15 scale. It is a scale consisting of 15 questions and scoring from 0 to 10 for each question. 0 represents the worst and 150 represents the best recovery quality. | Postoperative 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first antiemetic request | Time to first antiemetic request within 24 hours after surgery | Postoperative 24 hours |
| Time to request first oral drink | Time to request first oral drink within 24 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muhammet Korkusuz | Karamanoglu Mehmetbey University, School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karaman Taining and Research Hospital | Karaman | 70200 | Turkey (Türkiye) |
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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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There are two group;
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patients, care providers, and outcome assessors will be blinded.
| Restrictive Fluid Group | Other | Patients in this group will be administered 4 mL/kg/h ringer lactate intravenously peroperatively. |
|
|
| Postoperative 24 hours |
| First mobilization time | First mobilization time after surgery | Postoperative 24 hours |
| Total amount of analgesic | Total amount of rescue analgesic (tramadol) in the 24 hours after surgery | Postoperative 24 hours |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |