Postoperative Nausea and VomitingNCT06865378
The Correlation Between Intraoperative End Tidal Carbon Dioxide, Perfusion Index and Pulse Variability Index on Postoperative Nausea Vomiting and Pain
An observational study of Postoperative Nausea and Vomiting and Postoperative Pain, Acute, run by Naime Yalçın at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pain, which is frequently encountered in laparoscopic operations, has been examined in different studies with end tidal CO2 (end tidal carbon dioxide), total insufflated gas amount and PI (Perfusion index) parameters. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting, Postoperative Pain, Acute, End Tidal Carbon Dioxide
- What is being tested?
- Carbon dioxide (CO2) gas insufflation
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2021to 31 Dec 2025
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: A prospective, randomized, controlled study was initiated at Kanuni Sultan Süleyman E.A.H. to measure the carbon dioxide changes that develop during laparoscopic operations with non-invasive monitoring, to evaluate the correlation between them, and to investigate their effects on postoperative pain and nausea and vomiting.
Who may be able to join
- Planned for elective total laparoscopic hysterectomy
- 20-65 years old
- ASA I - II
Who cannot join
- history of intracranial disease
- lung disease
- systemic hypertension
- ischemic heart disease
- history of postoperative nausea and vomiting in previous operations
- smoking habit
Show all 13Show fewer
- motion sickness
- liver and kidney dysfunction
- abnormal fluid-electrolyte balance
- preoperative use of antiemetic drugs
- severe heart failure
- ASA III and above
- body mass index> 35 kg m2
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sağlık Bilimleri Üniversitesi Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi
Istanbul, 34000
About this study
Official title: The Correlation Between Intraoperative End Tidal Carbon Dioxide, Perfusion Index and Pulse Variability Index on Postoperative Nausea Vomiting and Pain; Prospective Study
Postoperative pain, which is frequently encountered in laparoscopic operations, has been examined in different studies with end tidal CO2 (end tidal carbon dioxide), total insufflated gas amount and PI (Perfusion index) parameters. PONV (postoperative nausea and vomiting), which is encountered more frequently than pain in the postoperative period, has been examined in relation to end tidal CO2. In this study, it was aimed to evaluate the development of postoperative pain and PONV, which affect recovery and patient comfort, by comparing the relationship between end tidal CO2, PI and PVI (Pulse variability index).
Read the detailed description
In recent years, laparoscopic gynecologic surgery has become a preferred technique over traditional open surgery due to its benefits such as better cosmetic results, lower risk of bleeding, minimally invasive surgery, lower postoperative pain and incidence of wound infection, and as a result, earlier discharge.
PI (Perfusion index), the ratio of alternating current component to direct current component, is a representation of the photoplethysmography waveform that quantitatively reflects real-time changes in peripheral blood flow in the monitored region. PVI (Pulse variability index) is another dynamic index and many studies have concluded that it is useful in assessing fluid responsiveness in patients. However, there are still uncertainties in the study regarding the effect of pneumoperitoneum on PVI. PVI, calculated from respiratory variations in perfusion index, has been shown to predict fluid responsiveness in mechanically ventilated patients; however, vasomotor tone changes induced by hypercapnia may affect PI and therefore reduce the accuracy of PVI.
Artificial pneumoperitoneum, which is commonly used in laparoscopic procedures and created with the Trendelenburg position and CO2 (carbon dioxide) insufflation, frequently leads to physiological changes such as PONV (postoperative nausea and vomiting) and pain. Although the mechanisms underlying its development are still unclear, PONV is caused by dopamine and serotonin released as a result of ischemia in the brain and intestinal tract, stimulating the medullary vomiting center. Therefore, ischemia has been shown to be one of the important factors for PONV. Hypocapnia is known to be associated with decreased cardiac output, and increased systematic vascular resistance can reduce blood flow in the brain and intestinal tract. Therefore, this study concluded that intraoperative hypocapnia may increase the risk of PONV. Another study reported that CO2 is a strong vasodilator and that intraoperative hypercarbia may be associated with increased perfusion to regions effective for PONV, including the brain and gastrointestinal tract. In a study examining the relationship between PI and postoperative pain, it was stated that there was a decrease in PI due to the activation of the sympathetic nervous system by pain, contraction in peripheral blood vessels and an increase in vasomotor tone, and an increase in PI values after the use of analgesics.
- Conditions
- Postoperative Nausea and Vomiting, Postoperative Pain, Acute, End Tidal Carbon Dioxide, Perfusion Index and Pleth Variability Index
- Being tested
- Carbon dioxide (CO2) gas insufflation
- Medical subject headings
- Postoperative Nausea and Vomiting, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon dioxide (CO2) gas insufflationProcedure or surgery
Artificial pneumoperitoneum created by the Trendelenburg position and carbon dioxide (CO2) insufflation, which is widely used in laparoscopic procedures, frequently leads to physiological changes such as postoperative nausea and vomiting (PONV) and pain. Therefore, the currently limited usable parameters PI and PVI will be evaluated in correlation with end tidal CO2 in continuous monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Arm Hypocarbia | Not described Receives: Procedure: Carbon dioxide (CO2) gas insufflation | |
| Arm normocarbia | Not described Receives: Procedure: Carbon dioxide (CO2) gas insufflation | |
| Arm hypercarbia | Not described Receives: Procedure: Carbon dioxide (CO2) gas insufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation of the incidence of postoperative nausea, vomiting and pain
Measured: From enrollment to postoperative 1st week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start15 Mar 2021
- Primary completion15 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Naime Yalçın
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Naime Yalçın, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865378
- Sponsor's protocol ID
- KAEK/2021.02.62
- Status last verified
- Mar 2025
- First submitted
- 20 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Intraoperative End Tidal Carbon Dioxide, Perfusion Index and Pulse Variability Index on Postoperative Nausea Vomiting and Pain; Prospective Study
- ClinicalTrials.gov ID
- NCT06865378
- Acronym / sponsor ID
- KAEK/2021.02.62
- Conditions
- Postoperative Nausea and Vomiting, Postoperative Pain, Acute, End Tidal Carbon Dioxide, Perfusion Index and Pleth Variability Index
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Naime YalçınUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Mar 2025 (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.
Postoperative pain, which is frequently encountered in laparoscopic operations, has been examined in different studies with end tidal CO2 (end tidal carbon dioxide), total insufflated gas amount and PI (Perfusion index) parameters. PONV (postoperative nausea and vomiting), which is encountered more frequently than pain in the postoperative period, has been examined in relation to end tidal CO2. In this study, it was aimed to evaluate the development of postoperative pain and PONV, which affect recovery and patient comfort, by comparing the relationship between end tidal CO2, PI and PVI (Pulse variability index).
Detailed description
In recent years, laparoscopic gynecologic surgery has become a preferred technique over traditional open surgery due to its benefits such as better cosmetic results, lower risk of bleeding, minimally invasive surgery, lower postoperative pain and incidence of wound infection, and as a result, earlier discharge.
PI (Perfusion index), the ratio of alternating current component to direct current component, is a representation of the photoplethysmography waveform that quantitatively reflects real-time changes in peripheral blood flow in the monitored region. PVI (Pulse variability index) is another dynamic index and many studies have concluded that it is useful in assessing fluid responsiveness in patients. However, there are still uncertainties in the study regarding the effect of pneumoperitoneum on PVI. PVI, calculated from respiratory variations in perfusion index, has been shown to predict fluid responsiveness in mechanically ventilated patients; however, vasomotor tone changes induced by hypercapnia may affect PI and therefore reduce the accuracy of PVI.
Artificial pneumoperitoneum, which is commonly used in laparoscopic procedures and created with the Trendelenburg position and CO2 (carbon dioxide) insufflation, frequently leads to physiological changes such as PONV (postoperative nausea and vomiting) and pain. Although the mechanisms underlying its development are still unclear, PONV is caused by dopamine and serotonin released as a result of ischemia in the brain and intestinal tract, stimulating the medullary vomiting center. Therefore, ischemia has been shown to be one of the important factors for PONV. Hypocapnia is known to be associated with decreased cardiac output, and increased systematic vascular resistance can reduce blood flow in the brain and intestinal tract. Therefore, this study concluded that intraoperative hypocapnia may increase the risk of PONV. Another study reported that CO2 is a strong vasodilator and that intraoperative hypercarbia may be associated with increased perfusion to regions effective for PONV, including the brain and gastrointestinal tract. In a study examining the relationship between PI and postoperative pain, it was stated that there was a decrease in PI due to the activation of the sympathetic nervous system by pain, contraction in peripheral blood vessels and an increase in vasomotor tone, and an increase in PI values after the use of analgesics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm Hypocarbia | – | Procedure: Carbon dioxide (CO2) gas insufflation |
| Arm normocarbia | – | Procedure: Carbon dioxide (CO2) gas insufflation |
| Arm hypercarbia | – | Procedure: Carbon dioxide (CO2) gas insufflation |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A prospective, randomized, controlled study was initiated at Kanuni Sultan Süleyman E.A.H. to measure the carbon dioxide changes that develop during laparoscopic operations with non-invasive monitoring, to evaluate the correlation between them, and to investigate their effects on postoperative pain and nausea and vomiting.
Key inclusion criteria (3 listed)
- Planned for elective total laparoscopic hysterectomy
- 20-65 years old
- ASA I - II
Key exclusion criteria (13 listed)
- history of intracranial disease
- lung disease
- systemic hypertension
- ischemic heart disease
- history of postoperative nausea and vomiting in previous operations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbon dioxide (CO2) gas insufflationArtificial pneumoperitoneum created by the Trendelenburg position and carbon dioxide (CO2) insufflation, which is widely used in laparoscopic procedures, frequently leads to physiological changes such as postoperative nausea and vomiting (PONV) and pain. Therefore, the currently limited usable parameters PI and PVI will be evaluated in correlation with end tidal CO2 in continuous monitoring. | Procedure or surgery | Arm Hypocarbia, Arm hypercarbia, Arm normocarbia |
Primary outcome
Investigation of the incidence of postoperative nausea, vomiting and pain
Time frame: From enrollment to postoperative 1st week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 and Postoperative Pain, Acute, run by Naime Yalçın at 1 site 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 3 inclusion and 13 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: enrolling by invitation, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigation of the incidence of postoperative nausea, vomiting and pain (time frame: From enrollment to postoperative 1st week). 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 7 Mar 2025.