Postoperative Nausea and VomitingNCT03472209
Comparison of Different EtCO2 Levels in Preventing Postoperative Nausea and Vomiting
An observational study of Postoperative Nausea and Vomiting, run by Karadeniz Technical University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 22 Jan 2018to 1 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients with gynecological laparoscopic surgery
Who may be able to join
- 25-50 age, ASA I / II, BMI: 18-33 kg/m2, operation time: 50-130 min., gynecological laparoscopy
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Karadeniz Teknik Universitesi
Trabzon, 61080
Ahmet Besir, MD, +90 4623775398 ext. 5398, ahmetbesir61@gmail.com
- Not yet recruiting
Karadeniz Technical University, Dept Obs and Gyn / Anestesiology
Trabzon
Ahmet Besir, MD, +904623775396, ahmetbesir61@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Postoperative Nausea and Vomiting, Gynecological Laparoscopic Surgery, End-tidal carbon dioxide
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | ETCO2=26-35 mmHg | |
| Group B | ETCO2=36-45 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
EtCO2
End tidal carbondioxide
Measured: During the operation (in 10 minutes interval)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start22 Jan 2018
- Primary completion15 May 2019
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Besir, Karadeniz Technical University
- Investigators
- Ahmet Besir, MD, Study chair, Karadeniz Teknit Üniversitesi Tıp Fakültesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472209
- Sponsor's protocol ID
- 2017/237
- Status last verified
- Nov 2019
- First submitted
- 14 Mar 2018
- Last updated
- 6 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different EtCO2 Levels in Preventing Postoperative Nausea and Vomiting in Gynecological Patients Undergoing Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT03472209
- Acronym / sponsor ID
- 2017/237
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Postoperative Nausea and Vomiting, Gynecological Laparoscopic Surgery, End-tidal carbon dioxide
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –ETCO2=26-35 mmHg |
| Group B | – | –ETCO2=36-45 mmHg |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with gynecological laparoscopic surgery
Key inclusion criteria (1 listed)
- 25-50 age, ASA I / II, BMI: 18-33 kg/m2, operation time: 50-130 min., gynecological laparoscopy
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EtCO2
Time frame: During the operation (in 10 minutes interval)
End tidal carbondioxide
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet Besir, MD study chair
Karadeniz Teknit Üniversitesi Tıp Fakültesi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Nausea and Vomiting, run by Karadeniz Technical University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmet Besir (+90 4623775398 ext. 5398, ahmetbesir61@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EtCO2 (time frame: During the operation (in 10 minutes interval)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.