Antiemetics, Nausea, Postoperative, Pain, Postoperative, Patient Reported Outcomes, Vomiting, Postoperative
Conditions
Brief summary
Evaluate the safety and efficacy of palonosetron versus ondansetron to reduce and control post-operative nausea in bariatric surgery.
Detailed description
Postoperative nausea and vomiting (PONV) is an undesirable clinical condition that increases the likelihood of dehiscence, bleeding, pulmonary aspiration of gastric contents, and electrolyte loss that lead to increased costs, prolonged hospital stays, and delayed recovery. In recent years, selective serotonin 5-hydroxytryptamine sub-type 3 (5-HT3) receptor antagonists such as ondansetron, granisetron, palonosetron have been introduced because they are effective in the prevention and treatment of PONV in bariatric surgery. In this study, the effects of ondansetron and palonosetron on PONV in patients who undergo sleeve gastrectomy will be compared.
Interventions
PROCEDURELaparoscopic sleeve gastrectomy
Sleeve gastrectomy, also called a vertical sleeve gastrectomy, is a surgical weight-loss procedure. This procedure is typically performed laparoscopically, which involves inserting small instruments through multiple small incisions in the upper abdomen. During sleeve gastrectomy, about 80 percent of the stomach is removed, leaving a tube-shaped stomach about the size and shape
DRUGPalonosetron 1mcg/kg
Injectable Palonosetron 1 mcg/kg diluted up to 5 mL with normal saline solution and injected intravenously at the end of the bariatric surgery.
DRUGOndansetron 1 mg/kg, max dose 8 mg
Injectable ondansetron 0.1 mg/kg, maximum of 8 mg was injected intravenously at the end of the bariatric surgery.
Sponsors
Bagcilar Training and Research Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Inclusion criteria
* All morbidity obese patients underwent laparoscopic sleeve gastrectomy
Exclusion criteria
drug allergy, intractable nausea and vomiting, gastroesophageal reflux disease, pregnancy, menstruation, the occurrence of nausea or vomiting episodes in the last 24 h prior to surgery, the use of corticosteroids, smoking, alcoholism, the use of psychoactive drugs or any other drug with antiemetic effects, hypersensitivity to other 5-HT3 antagonists, emergency surgeries and chemotherapy within.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| amount of rescue anti-emetic drugs | postoperative seventh day | Number of anti emetic metoclopramide intravenous injections during hospitalization and the postoperative one week. |
| Nause and vomiting 6hr | postoperative 6 hours | Visual Analog Scale score for nausea and vomiting |
| Nause and vomiting 24hr | postoperative 24 hours | Visual Analog Scale score for nausea and vomiting |
| Nause and vomiting 48hr | postoperative 48 hours | Visual Analog Scale score for nausea and vomiting |
| Nause and vomiting 72hr | postoperative 72 hours | Visual Analog Scale score for nausea and vomiting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain 6hr | postoperative 6 hours | Visual Analog Scale score for pain |
| Pain 24hr | postoperative 24 hours | Visual Analog Scale score for pain |
| Pain 48hr | postoperative 48 hours | Visual Analog Scale score for pain |
| Pain 72hr | postoperative 72 hours | Visual Analog Scale score for pain |
Other
| Measure | Time frame | Description |
|---|---|---|
| Functional living index- Emesis | postoperative seventh day | Quality of life after discharge about emesis using Functional living index- Emesis |
Countries
Turkey (Türkiye)
Outcome results
None listed