Preemptive Versus Preventive Antiemetic Treatment
- Conditions
- Postoperative Nausea and Vomiting
- Interventions
- Other: Antiemetics perioperatively
- Registration Number
- NCT03023306
- Lead Sponsor
- University of Athens
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 115
- ASA physical status I-III patients
- Surgical procedure: scheduled for laparoscopic cholecystectomy
- Type of anesthesia: general
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description preemptive group Antiemetics perioperatively 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 Antiemetics perioperatively 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
- Primary Outcome Measures
Name Time Method PONV (postoperative nausea vomiting combined) 24 hours Incidence of combined nausea and vomiting postoperatively
- Secondary Outcome Measures
Name Time Method postoperative vomiting frequency 24 hours number of vomits
postoperative nausea frequency and intensity 24 hours numerical rating scale of nausea intensity (0-10)
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
Trial Locations
- Locations (1)
Aretaieio University Hospital
🇬🇷Athens, Attika, Greece