Preemptive Versus Preventive Antiemetic Treatment

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Preemptive Versus Preventive Antiemetic Treatment in Patients Undergoing Laparoscopic Cholecystectomy. A Randomized Double Blind Trial.

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Other: Antiemetics perioperatively


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: preemptive group<br>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 | Other: Antiemetics perioperatively<br>* Preemptive group ondansetron 4 mg will be administered 1h before surgery Intraoperative group Ondansetron 4 mg will be administered intraoperatively<br>|
| Other: intraoperative group<br>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 | Other: Antiemetics perioperatively<br>* Preemptive group ondansetron 4 mg will be administered 1h before surgery Intraoperative group Ondansetron 4 mg will be administered intraoperatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PONV (postoperative nausea vomiting combined) | Incidence of combined nausea and vomiting postoperatively | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative nausea frequency and intensity | numerical rating scale of nausea intensity (0-10) | 24 hours | 
| postoperative vomiting frequency | number of vomits | 24 hours | 
| postoperative pain | numerical rating scale of pain intensity (0-10) | 24 hours | 
| retching | if retching exists | 24 hours | 
| PONV (postoperative nausea vomiting combined) | frequency and intensity of nausea and vomiting | 24 hours |