Preemptive Versus Preventive Antiemetic Treatment

Not Applicable

• Conditions: Postoperative Nausea and Vomiting

• 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

Study Timeline

• Study First Submitted: 2017-01-13
• Study First Submitted QC: 2017-01-13
• Study First Posted: 2017-01-18
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-31
• Study Start: 2018-11
• Last Update Posted: 2018-11-02
• Primary Completion: 2020-11
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 115

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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