Back to resultsPostoperative Nausea and Vomiting in Laparoscopic Abdominal Surgery (PONV)
Primary Purpose
Postoperative Nausea, Vomiting
Status
Not yet recruiting
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Aprepitant
Granisetron
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Nausea focused on measuring postoperative nausea and vomiting, laparoscopic surgery
Eligibility Criteria
Inclusion Criteria: ASA I, II patients patients undergoing laparoscopic surgery Exclusion Criteria: ASA III and above patients who refused to participate in the study
Sites / Locations
- Baskent University Ankara Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Aprepitant
Granisetron
Arm Description
Substance P inhibitor chemotherapeutic and also useable for prevention of postoperative nausea and vomiting
5- HT3( 5-hydroksitriptamine 3) antagonist drug for prevention of postoperative nausea and vomiting
Outcomes
Primary Outcome Measures
incidence of nausea
the incidence of nausea between 0-6 and 6-24 hours postoperatively
the need for additional antiemetics
the need for additional antiemetics between 0-6 and 6-24 hours postoperatively
incidence of vomiting
the incidence of vomiting between 0-6 and 6-24 hours postoperatively
Secondary Outcome Measures
additional analgesic need
Detection of additional analgesic needs between 0-6 and 6-24 hours postoperatively.
detection of complications
detection of complications between 0-6 and 6-24 hours postoperatively.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05632224
Brief Title
Postoperative Nausea and Vomiting in Laparoscopic Abdominal Surgery
Acronym
PONV
Official Title
Retrospective Comparison of the Effects of Granisetron and Aprepitant in the Prevention of Postoperative Nausea and Vomiting in Laparoscopic Abdominal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 24, 2022 (Anticipated)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea, Vomiting
Keywords
postoperative nausea and vomiting, laparoscopic surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
group 1:patient who receive aprepitant group 2: patient who receive granisetron
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aprepitant
Arm Type
Active Comparator
Arm Description
Substance P inhibitor chemotherapeutic and also useable for prevention of postoperative nausea and vomiting
Arm Title
Granisetron
Arm Type
Active Comparator
Arm Description
5- HT3( 5-hydroksitriptamine 3) antagonist drug for prevention of postoperative nausea and vomiting
Intervention Type
Drug
Intervention Name(s)
Aprepitant
Other Intervention Name(s)
Emend
Intervention Description
The drug is given 1 hour before the start of the surgery
Intervention Type
Drug
Intervention Name(s)
Granisetron
Other Intervention Name(s)
Sinarex
Intervention Description
The drug is given 10 minutes before the patients's extubation
Primary Outcome Measure Information:
Title
incidence of nausea
Description
the incidence of nausea between 0-6 and 6-24 hours postoperatively
Time Frame
postoperative 24 hours
Title
the need for additional antiemetics
Description
the need for additional antiemetics between 0-6 and 6-24 hours postoperatively
Time Frame
postoperative 24 hours
Title
incidence of vomiting
Description
the incidence of vomiting between 0-6 and 6-24 hours postoperatively
Time Frame
postoperative 24 hours
Secondary Outcome Measure Information:
Title
additional analgesic need
Description
Detection of additional analgesic needs between 0-6 and 6-24 hours postoperatively.
Time Frame
postoperative 24 hours
Title
detection of complications
Description
detection of complications between 0-6 and 6-24 hours postoperatively.
Time Frame
postoperative 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ASA I, II patients patients undergoing laparoscopic surgery
Exclusion Criteria:
ASA III and above patients who refused to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Begüm Ne Gökdemir, MD
Phone
+905389598290
Email
begokdemir@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nedim Çekmen, Professor
Phone
+905307384682
Email
nedimcekmen@yahoo.com
Facility Information:
Facility Name
Baskent University Ankara Hospital
City
Ankara
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nedim Çekmen, Professor;MD
Phone
+905307384682
Email
nedimcekmen@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Postoperative Nausea and Vomiting in Laparoscopic Abdominal Surgery
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