- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03472209
Comparison of Different EtCO2 Levels in Preventing Postoperative Nausea and Vomiting
November 5, 2019 updated by: Ahmet Besir, Karadeniz Technical University
Comparison of Different EtCO2 Levels in Preventing Postoperative Nausea and Vomiting in Gynecological Patients Undergoing Laparoscopic Surgery
We aimed to evaluate the different ETCO2 levels (with the help of ultrasonographic optic nerve sheath diameter) in preventing gynecological laparoscopic surgeons' postoperative nausea induced by intracranial pressure change due to pneumoperitoneum and trandelenburg position.
Study Overview
Status
Unknown
Conditions
Detailed Description
Although gynecologic laparoscopic surgery is a preferred technique in recent years due to its minimally invasive technique, the incidence of postoperative nausea and vomiting (PONV) is 53-72%.
In such operations, intra-abdominal pressure due to trandelenburg position and carbondioxide insufflation causes intra-cranial venous obstruction and intra-cranial pressure increase.
In addition, intra-cranial blood flow and ultimately intra-cranial pressure increase due to gravity and increased venous return resistance (peripheral vascular resistance).
Intra-cranial CO2 concentration increase results in intra-cranial vascular dilatation, followed by ICP increase.
High intracranial pressure may cause an increase in the incidence of PONV after gynecological laparoscopic surgery.
Measurement of optic nerve sheath diameter with USG, a noninvasive method for detecting intracranial pressure increases, has been used frequently in intensive care units in recent years.
we aimed to evaluate the different ETCO2 levels (during the operation with 10 minute intervals, and also with the help of ultrasonographic optic nerve sheath diameter) in preventing gynecological laparoscopic surgeons' postoperative nausea induced by intracranial pressure change due to pneumoperitoneum and trandelenburg position.
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ahmet Besir
- Phone Number: 5398 +90 4623775398
- Email: ahmetbesir61@gmail.com
Study Locations
-
-
-
Trabzon, Turkey, 61080
- Recruiting
- Karadeniz Teknik Üniversitesi
-
Contact:
- Ahmet Besir, MD
- Phone Number: 5398 +90 4623775398
- Email: ahmetbesir61@gmail.com
-
Trabzon, Turkey
- Not yet recruiting
- Karadeniz Technical University, Dept Obs and Gyn / Anestesiology
-
Contact:
- Ahmet Besir, MD
- Phone Number: +904623775396
- Email: ahmetbesir61@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Patients with gynecological laparoscopic surgery
Description
Inclusion Criteria:
25-50 age, ASA I / II, BMI: 18-33 kg/m2, operation time: 50-130 min., gynecological laparoscopy
Exclusion Criteria:
In previous operations, Patients with postoperative nausea-vomiting (PONV) history, Smoking, Vehicle stays, Liver and kidney dysfunction, Abnormal fluid electrolyte balance, Gastrointestinal system disease, Preoperative antiemetic drug use, Cerebral disease,dysrhythmia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Group A
ETCO2=26-35 mmHg
|
Group B
ETCO2=36-45 mmHg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EtCO2
Time Frame: During the operation (in 10 minutes interval)
|
End tidal carbondioxide
|
During the operation (in 10 minutes interval)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Ahmet Besir, MD, Karadeniz Teknit Üniversitesi Tıp Fakültesi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 22, 2018
Primary Completion (Actual)
May 15, 2019
Study Completion (Anticipated)
November 1, 2020
Study Registration Dates
First Submitted
March 14, 2018
First Submitted That Met QC Criteria
March 20, 2018
First Posted (Actual)
March 21, 2018
Study Record Updates
Last Update Posted (Actual)
November 6, 2019
Last Update Submitted That Met QC Criteria
November 5, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/237
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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