Postoperative Nausea and Vomiting
Conditions
Brief summary
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.
Interventions
OTHERAntiemetics perioperatively
Preemptive group ondansetron 4 mg will be administered 1h before surgery Intraoperative group Ondansetron 4 mg will be administered intraoperatively
Sponsors
University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* ASA physical status I-III patients * Surgical procedure: scheduled for laparoscopic cholecystectomy * Type of anesthesia: general
Exclusion criteria
* Antihistamines the last three days * Antiemetic drugs the last three days * Hiatus hernia * reflux * Gastrointestinal disease * Pregnancy * BMI \> 35 * parkinson * known allergy to the drugs of the protocol * epilepsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PONV (postoperative nausea vomiting combined) | 24 hours | Incidence of combined nausea and vomiting postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative nausea frequency and intensity | 24 hours | numerical rating scale of nausea intensity (0-10) |
| postoperative vomiting frequency | 24 hours | number of vomits |
| postoperative pain | 24 hours | numerical rating scale of pain intensity (0-10) |
| retching | 24 hours | if retching exists |
| PONV (postoperative nausea vomiting combined) | 24 hours | frequency and intensity of nausea and vomiting |
Countries
Greece
Contacts
Primary ContactArgyro Fassoulaki, MD PhD DEAA
Backup ContactChryssoula Staikou, MD, PhD, DESA
Outcome results
None listed