Preemptive Versus Preventive Antiemetic Treatment

National and Kapodistrian University of Athens

Status: Unknown

Conditions: Postoperative Nausea and Vomiting

Treatments: Other: Antiemetics perioperatively

Study type: Interventional

Funder types: Other

Identifiers

NCT03023306

IRB No 65/19-06-18

Details and patient eligibility

About

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.

Enrollment: 115 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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115 participants in 2 patient groups

preemptive group

Active Comparator group

Description:

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

Treatment:

Other: Antiemetics perioperatively

intraoperative group

Other group

Description:

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

Treatment:

Other: Antiemetics perioperatively