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

Study Locations

  • Turkey
      • Trabzon, Turkey, 61080
        • Recruiting
        • Karadeniz Teknik Üniversitesi
        • Contact:
      • Trabzon, Turkey
        • Not yet recruiting
        • Karadeniz Technical University, Dept Obs and Gyn / Anestesiology
        • Contact:

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

Karadeniz Technical University

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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