Postoperative Nausea and Vomiting in Laparoscopic Abdominal Surgery (PONV)

Baskent University

Status and phase: Not yet enrolling; Phase 4

Conditions: Vomiting; Postoperative Nausea

Treatments: Drug: Granisetron; Drug: Aprepitant

Study type: Interventional

Funder types: Other

Identifiers

NCT05632224

KA22/252

Details and patient eligibility

About

The goal of this clinical trial is to compare frequency with postoperative nausea and vomiting in ASA( American Society of Anesthesiologists) I, II patients undergoing laparoscopic surgery.

The main question[s] it aims to answer are:

• Primary Outcome is the incidence of nausea and vomiting between 0-6 and 6-24 hours postoperatively and the need for additional antiemetics
• Secondary outcome is detection of additional analgesic needs and complications between 0-6 and 6-24 hours postoperatively.

Participants will receive aprepitant or granisetron for prevention of postoperative nausea and vomiting.

Full description

The aim of this study is to investigate the effectiveness of drugs used for postoperative nausea and vomiting in laparoscopic surgeries.

In the research; During the operation, the patient's vitals will be recorded intraoperative forms. Vitals are; heart rate, blood pressure, oxygen saturation, end tidal carbon dioxide levels; according to the pain level after awakening from the patient follow-up forms in the service.

The doses and times of analgesics will be screened, the frequencies of postoperative nausea, retching, vomiting, and additional antiemetic doses will be screened, respiratory depression, complications of anesthesia, arrhythmia, laryngospasm, hypo-hypertension, headache, dizziness, allergic reactions anxiety symptoms will be screened too.

we will try to emphasize which antiemetic is more effective than the other and which one has few side effects

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA I, II patients patients undergoing laparoscopic surgery

Exclusion criteria

• ASA III and above patients who refused to participate in the study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Aprepitant

Active Comparator group

Description:

Substance P inhibitor chemotherapeutic and also useable for prevention of postoperative nausea and vomiting

Treatment:

Drug: Aprepitant

Granisetron

Active Comparator group

Description:

5- HT3( 5-hydroksitriptamine 3) antagonist drug for prevention of postoperative nausea and vomiting

Treatment:

Drug: Granisetron