Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 122 for:    Recruiting, Not yet recruiting, Available Studies | Nausea and vomiting
Previous Study | Return to List | Next Study

Comparison of Different EtCO2 Levels in Preventing Postoperative Nausea and Vomiting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03472209
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmet Besir, Karadeniz Technical University

Brief Summary:
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.

Condition or disease
Postoperative Nausea and Vomiting

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison of Different EtCO2 Levels in Preventing Postoperative Nausea and Vomiting in Gynecological Patients Undergoing Laparoscopic Surgery
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : April 15, 2018
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Group A
ETCO2=26-35 mmHg
Group B
ETCO2=36-45 mmHg



Primary Outcome Measures :
  1. EtCO2 [ Time Frame: During the operation (in 10 minutes interval) ]
    End tidal carbondioxide



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with gynecological laparoscopic surgery
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472209


Contacts
Layout table for location contacts
Contact: Ahmet Besir +90 4623775398 ext 5398 ahmetbesir61@gmail.com

Locations
Layout table for location information
Turkey
Karadeniz Teknik Universitesi Recruiting
Trabzon, Turkey, 61080
Contact: Ahmet Besir, MD    +90 4623775398 ext 5398    ahmetbesir61@gmail.com   
Karadeniz Technical University, Dept Obs and Gyn / Anestesiology Not yet recruiting
Trabzon, Turkey
Contact: Ahmet Besir, MD    +904623775396    ahmetbesir61@gmail.com   
Sponsors and Collaborators
Karadeniz Technical University
Investigators
Layout table for investigator information
Study Chair: Ahmet Besir, MD Karadeniz Teknit Üniversitesi Tıp Fakültesi

Layout table for additonal information
Responsible Party: Ahmet Besir, Assistant professor, Karadeniz Technical University
ClinicalTrials.gov Identifier: NCT03472209     History of Changes
Other Study ID Numbers: 2017/237
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ahmet Besir, Karadeniz Technical University:
Postoperative Nausea and Vomiting
Gynecological Laparoscopic Surgery
End-tidal carbon dioxide

Additional relevant MeSH terms:
Layout table for MeSH terms
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes