Postoperative Nausea and Vomiting
Conditions
Keywords
Postoperative Nausea and Vomiting, Laparoscopic Cholecystectomy
Brief summary
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.
Detailed description
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.
Interventions
OTHERLiberal Fluid Grubu
Patients in this group will be administered 20 mL/kg/h ringer lactate intravenously peroperatively.
OTHERRestrictive Fluid Group
Patients in this group will be administered 4 mL/kg/h ringer lactate intravenously peroperatively.
Sponsors
Karaman Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
patients, care providers, and outcome assessors will be blinded.
Intervention model description
There are two group; 1. Experimental Group: Group L; Liberal Fluid Group; Peroperative 20 mL/kg/h intravenous ringer lactate will be administered. 2. Sham Comparator: Group R; Restrictive Fluid Group; Peroperative 5 mL/kg/h intravenous ringer lactate will be administered.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients planned for laparoscopic cholecystectomy * Patients aged 18-70
Exclusion criteria
* Congestive heart failure. * Diabetes. * Epilepsy. * Heart valve disease. * They are pregnant. * Chronic liver disease. * Chronic kidney disease. Chronic gastrointestinal tract disease. Those who used antiemetic drugs within 24 hours before surgery. Those who developed intraoperative hypertension. Those who develop excessive blood loss. Patients whose surgery procedure takes more than 2 hours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative nausea-vomiting | Postoperative 24 hours | 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. |
| Quality of recovery | Postoperative 24 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first antiemetic request | Postoperative 24 hours | Time to first antiemetic request within 24 hours after surgery |
| Time to request first oral drink | Postoperative 24 hours | Time to request first oral drink within 24 hours after surgery |
| First mobilization time | Postoperative 24 hours | First mobilization time after surgery |
| Total amount of analgesic | Postoperative 24 hours | Total amount of rescue analgesic (tramadol) in the 24 hours after surgery |
Countries
Turkey (Türkiye)
Outcome results
None listed