Pain, PostoperativeNCT06114277
The Relationship Between Intraoperative ETCO2 Levels and Postoperative Pain and Nausea-Vomiting
An observational study of Pain, Postoperative and Nausea, Postoperative, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to investigate the relationship between intraoperative ETCO2 levels and postoperative nausea-vomiting and pain scores in patients undergoing robotic laparoscopic radical prostatectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Pain, Postoperative, Nausea, Postoperative, Vomiting, Postoperative
- What is being tested?
- ETCO2 levels and Patients with high ETCO2 levels
- How many people
- 109 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2024to 15 Aug 2024
- 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The aim of our study is to investigate the relationship between intraoperative ETCO2 levels and postoperative nausea, vomiting, and pain scores in patients undergoing robotic laparoscopic radical prostatectomy. We will monitor patients' 24-hour postoperative pain, nausea, vomiting, and the consumption of additional analgesic and antiemetic medications.
Who may be able to join
- Individuals between the ages of 18 and 80.
- Patients with American Society of Anesthesiologists (ASA) scores I, II, or III.
- Patients who have undergone robotic laparoscopic prostatectomy in the operating room.
Who cannot join
- Patients under 18 years old or over 80 years old.
- Patients with American Society of Anesthesiologists (ASA) scores IV and above.
- Patients who refuse to participate in the study.
- Patients undergoing emergency surgery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, 06170
About this study
Official title: The Relationship Between Intraoperative ETCO2 Levels and Postoperative Pain and Nausea-Vomiting in Laparoscopic Robotic Prostatectomy Patients
The aim of our study is to investigate the relationship between intraoperative ETCO2 levels and postoperative nausea-vomiting and pain scores in patients undergoing robotic laparoscopic radical prostatectomy. The investigators will monitor patients' 24-hour postoperative pain, nausea-vomiting and the consumption of additional analgesic and antiemetic medications.
Read the detailed description
Robotic surgery provides several advantages in the field of surgery, including a three-dimensional view of the surgical site, the elimination of surgeon hand tremors, and enhanced precision in movements. Additionally, it offers benefits such as reduced intraoperative bleeding, faster return to daily functions for patients, and decreased hospitalization duration. Consequently, the use of robots in various surgical procedures has become widespread in contemporary medical practice.
Robot-assisted laparoscopic radical prostatectomy is a surgical technique performed in a head-down Trendelenburg position with intraperitoneal insufflation of carbon dioxide (CO2). This positioning and pneumoperitoneum lead to an increase in intraabdominal pressure, as well as elevated intracranial and intraocular pressures.
End-tidal carbon dioxide (ETCO2) levels can vary during laparoscopic surgery. An increase in ETCO2 levels has been reported to cause an elevation in intracranial pressure, leading to an increased incidence of postoperative nausea and vomiting. Some studies in the literature have investigated the relationship between ETCO2 values and the incidence of postoperative nausea and vomiting in patients. Furthermore, it is believed that hypercarbia (elevated carbon dioxide levels) may have an impact on postoperative pain.
The aim of our study is to investigate the relationship between intraoperative ETCO2 levels and postoperative nausea, vomiting, and pain scores in patients undergoing robotic laparoscopic radical prostatectomy. The investigators will monitor patients' 24-hour postoperative pain, nausea, vomiting, and the consumption of additional analgesic and antiemetic medications.
- Being tested
- ETCO2 levels, Patients with high ETCO2 levels
- Keywords
- End-tidal carbon dioxide, Laparoscopic Robotic Prostatectomy
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETCO2 levelsOther
Also called Patients with low ETCO2 levels
Intraoperative ETCO2 values between 26 and 35 in laparoscopic robotic prostatectomy patients were included in group 1.
Patients with high ETCO2 levelsOther
Intraoperative ETCO2 values between 36 and 45 in laparoscopic robotic prostatectomy patients were included in group 2.
| Study group | Role | What they receive |
|---|---|---|
| Patients with low ETCO2 levels | Intraoperative ETCO2 values between 26 and 35 in laparoscopic robotic prostatectomy patients were included in this group. Receives: Other: ETCO2 levels | |
| Patients with high ETCO2 levels | Intraoperative ETCO2 values between 36 and 45 in laparoscopic robotic prostatectomy patients were included in this group. Receives: Other: Patients with high ETCO2 levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative nausea and vomiting (PONV) Score
Postoperative nausea and vomiting recording in patients.
- 0=no PONV: patient reports no nausea and has had no emesis episodes;
- 1=mild PONV: patient reports nausea but declines antiemetic treatment;
- 2=moderate PONV: patient reports nausea and accepts antiemetic treatment; and
- 3=severe PONV: nausea with any emesis episode (retching or vomiting). Higher scores indicate severe postoperative nausea and vomitting.
Measured: 0-2-4-8-12-24 hours postoperatively
Secondary outcomes (1)
Pain on the Numeric Rating Scale (NRS)
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
Measured: 0-2-4-8-12-24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start10 Jun 2024
- Primary completion2 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yusuf Özgüner, Ankara Etlik City Hospital
- Investigators
- Yusuf Ozguner, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114277
- Sponsor's protocol ID
- AnkaraEtlikYusufOzguner005
- Status last verified
- May 2025
- First submitted
- 29 Oct 2023
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aceto P, Beretta L, Cariello C, Claroni C, Esposito C, Forastiere EM, Guarracino F, Perucca R, Romagnoli S, Sollazzi L, Cela V, Ercoli A, Scambia G, Vizza E, Ludovico GM, Sacco E, Vespasiani G, Scudeller L, Corcione A; Societa Italiana di Anestesia Analgesia Rianimazione e Terapia Intensiva (SIAARTI), Societa Italiana di Ginecologia e Ostetricia (SIGO), and Societa Italiana di Urologia (SIU). Joint consensus on anesthesia in urologic and gynecologic robotic surgery: specific issues in management from a task force of the SIAARTI, SIGO, and SIU. Minerva Anestesiol. 2019 Aug;85(8):871-885. doi: 10.23736/S0375-9393.19.13360-3. Epub 2019 Mar 29.
PubMed 30938121Besir A, Tugcugil E. Comparison of different end-tidal carbon dioxide levels in preventing postoperative nausea and vomiting in gynaecological patients undergoing laparoscopic surgery. J Obstet Gynaecol. 2021 Jul;41(5):755-762. doi: 10.1080/01443615.2020.1789961. Epub 2020 Oct 12.
PubMed 33045886Son JS, Oh JY, Ko S. Effects of hypercapnia on postoperative nausea and vomiting after laparoscopic surgery: a double-blind randomized controlled study. Surg Endosc. 2017 Nov;31(11):4576-4582. doi: 10.1007/s00464-017-5519-8. Epub 2017 Apr 7.
PubMed 28389799
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Intraoperative ETCO2 Levels and Postoperative Pain and Nausea-Vomiting in Laparoscopic Robotic Prostatectomy Patients
- ClinicalTrials.gov ID
- NCT06114277
- Acronym / sponsor ID
- AnkaraEtlikYusufOzguner005
- Keywords
- End-tidal carbon dioxide, Laparoscopic Robotic Prostatectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 2 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 2 Nov 2023 (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.
The aim of our study is to investigate the relationship between intraoperative ETCO2 levels and postoperative nausea-vomiting and pain scores in patients undergoing robotic laparoscopic radical prostatectomy. The investigators will monitor patients' 24-hour postoperative pain, nausea-vomiting and the consumption of additional analgesic and antiemetic medications.
Detailed description
Robotic surgery provides several advantages in the field of surgery, including a three-dimensional view of the surgical site, the elimination of surgeon hand tremors, and enhanced precision in movements. Additionally, it offers benefits such as reduced intraoperative bleeding, faster return to daily functions for patients, and decreased hospitalization duration. Consequently, the use of robots in various surgical procedures has become widespread in contemporary medical practice.
Robot-assisted laparoscopic radical prostatectomy is a surgical technique performed in a head-down Trendelenburg position with intraperitoneal insufflation of carbon dioxide (CO2). This positioning and pneumoperitoneum lead to an increase in intraabdominal pressure, as well as elevated intracranial and intraocular pressures.
End-tidal carbon dioxide (ETCO2) levels can vary during laparoscopic surgery. An increase in ETCO2 levels has been reported to cause an elevation in intracranial pressure, leading to an increased incidence of postoperative nausea and vomiting. Some studies in the literature have investigated the relationship between ETCO2 values and the incidence of postoperative nausea and vomiting in patients. Furthermore, it is believed that hypercarbia (elevated carbon dioxide levels) may have an impact on postoperative pain.
The aim of our study is to investigate the relationship between intraoperative ETCO2 levels and postoperative nausea, vomiting, and pain scores in patients undergoing robotic laparoscopic radical prostatectomy. The investigators will monitor patients' 24-hour postoperative pain, nausea, vomiting, and the consumption of additional analgesic and antiemetic medications.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with low ETCO2 levels | – | Other: ETCO2 levelsIntraoperative ETCO2 values between 26 and 35 in laparoscopic robotic prostatectomy patients were included in this group. |
| Patients with high ETCO2 levels | – | Other: Patients with high ETCO2 levelsIntraoperative ETCO2 values between 36 and 45 in laparoscopic robotic prostatectomy patients were included in this group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The aim of our study is to investigate the relationship between intraoperative ETCO2 levels and postoperative nausea, vomiting, and pain scores in patients undergoing robotic laparoscopic radical prostatectomy. We will monitor patients' 24-hour postoperative pain, nausea, vomiting, and the consumption of additional analgesic and antiemetic medications.
Key inclusion criteria (3 listed)
- Individuals between the ages of 18 and 80.
- Patients with American Society of Anesthesiologists (ASA) scores I, II, or III.
- Patients who have undergone robotic laparoscopic prostatectomy in the operating room.
Key exclusion criteria (4 listed)
- Patients under 18 years old or over 80 years old.
- Patients with American Society of Anesthesiologists (ASA) scores IV and above.
- Patients who refuse to participate in the study.
- Patients undergoing emergency surgery.
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 |
|---|---|---|
| ETCO2 levelsAlso: Patients with low ETCO2 levelsIntraoperative ETCO2 values between 26 and 35 in laparoscopic robotic prostatectomy patients were included in group 1. | Other | Patients with low ETCO2 levels |
| Patients with high ETCO2 levelsIntraoperative ETCO2 values between 36 and 45 in laparoscopic robotic prostatectomy patients were included in group 2. | Other | Patients with high ETCO2 levels |
Primary outcome
Postoperative nausea and vomiting (PONV) Score
Time frame: 0-2-4-8-12-24 hours postoperatively
Postoperative nausea and vomiting recording in patients. * 0=no PONV: patient reports no nausea and has had no emesis episodes; * 1=mild PONV: patient reports nausea but declines antiemetic treatment; * 2=moderate PONV: patient reports nausea and accepts antiemetic treatment; and * 3=severe PONV: nausea with any emesis episode (retching or vomiting). Higher scores indicate severe postoperative nausea and vomitting.
1 secondary outcome
Pain on the Numeric Rating Scale (NRS)
Time frame: 0-2-4-8-12-24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Results publication: PubMed 30938121Aceto P, Beretta L, Cariello C, Claroni C, Esposito C, Forastiere EM, Guarracino F, Perucca R, Romagnoli S, Sollazzi L, Cela V, Ercoli A, Scambia G, Vizza E, Ludovico GM, Sacco E, Vespasiani G, Scudeller L, Corcione A; Societa Italiana di Anestesia Analgesia Rianimazione e Terapia Intensiva (SIAARTI), Societa Italiana di Ginecologia e Ostetricia (SIGO), and Societa Italiana di Urologia (SIU). Joint consensus on anesthesia in urologic and gynecologic robotic surgery: specific issues in management from a task force of the SIAARTI, SIGO, and SIU. Minerva Anestesiol. 2019 Aug;85(8):871-885. doi: 10.23736/S0375-9393.19.13360-3. Epub 2019 Mar 29.
- Results publication: PubMed 33045886Besir A, Tugcugil E. Comparison of different end-tidal carbon dioxide levels in preventing postoperative nausea and vomiting in gynaecological patients undergoing laparoscopic surgery. J Obstet Gynaecol. 2021 Jul;41(5):755-762. doi: 10.1080/01443615.2020.1789961. Epub 2020 Oct 12.
- Results publication: PubMed 28389799Son JS, Oh JY, Ko S. Effects of hypercapnia on postoperative nausea and vomiting after laparoscopic surgery: a double-blind randomized controlled study. Surg Endosc. 2017 Nov;31(11):4576-4582. doi: 10.1007/s00464-017-5519-8. Epub 2017 Apr 7.
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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.
Yusuf Ozguner principal investigator
Ankara Etlik City Hospital
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 Pain, Postoperative and Nausea, Postoperative, run by Ankara Etlik City Hospital 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 4 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: finished, as of the sponsor's last update on 4 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative nausea and vomiting (PONV) Score (time frame: 0-2-4-8-12-24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06114277, which also lists 3 linked publications.
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 4 May 2025.