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Postoperative Nausea and Vomiting in Laparoscopic Abdominal Surgery

NCT ID: NCT05632224

Last Updated: 2022-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-24

Study Completion Date

2023-01-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Postoperative Nausea Vomiting

Keywords

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postoperative nausea and vomiting laparoscopic surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

group 1:patient who receive aprepitant group 2: patient who receive granisetron
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Aprepitant

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

Group Type ACTIVE_COMPARATOR

Aprepitant

Intervention Type DRUG

The drug is given 1 hour before the start of the surgery

Granisetron

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

Group Type ACTIVE_COMPARATOR

Granisetron

Intervention Type DRUG

The drug is given 10 minutes before the patients's extubation

Interventions

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Aprepitant

The drug is given 1 hour before the start of the surgery

Intervention Type DRUG

Granisetron

The drug is given 10 minutes before the patients's extubation

Intervention Type DRUG

Other Intervention Names

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Emend Sinarex

Eligibility Criteria

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Inclusion Criteria

* ASA I, II patients patients undergoing laparoscopic surgery

Exclusion Criteria

* ASA III and above patients who refused to participate in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Begüm Nemika Gökdemir

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Baskent University Ankara Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Begüm Ne Gökdemir, MD

Role: CONTACT

Phone: +905389598290

Email: [email protected]

Nedim Çekmen, Professor

Role: CONTACT

Phone: +905307384682

Email: [email protected]

Facility Contacts

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Nedim Çekmen, Professor;MD

Role: primary

Other Identifiers

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KA22/252

Identifier Type: -

Identifier Source: org_study_id