The Relationship Between Intraoperative ETCO2 Levels and Postoperative Pain and Nausea-Vomiting
1 other identifier
observational
109
1 country
1
Brief 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. The investigators will monitor patients' 24-hour postoperative pain, nausea-vomiting and the consumption of additional analgesic and antiemetic medications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2023
CompletedFirst Posted
Study publicly available on registry
November 2, 2023
CompletedStudy Start
First participant enrolled
June 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2024
CompletedMay 4, 2025
May 1, 2025
2 months
October 29, 2023
May 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
0-2-4-8-12-24 hours postoperatively
Secondary Outcomes (1)
Pain on the Numeric Rating Scale (NRS)
0-2-4-8-12-24 hours postoperatively
Study Arms (2)
Patients with low ETCO2 levels
Intraoperative ETCO2 values between 26 and 35 in laparoscopic robotic prostatectomy patients were included in this group.
Patients with high ETCO2 levels
Intraoperative ETCO2 values between 36 and 45 in laparoscopic robotic prostatectomy patients were included in this group.
Interventions
Intraoperative ETCO2 values between 26 and 35 in laparoscopic robotic prostatectomy patients were included in group 1.
Intraoperative ETCO2 values between 36 and 45 in laparoscopic robotic prostatectomy patients were included in group 2.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara Etlik City Hospital
Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, 06170, Turkey (Türkiye)
Related Publications (3)
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.
PMID: 30938121RESULTBesir 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.
PMID: 33045886RESULTSon 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.
PMID: 28389799RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yusuf Ozguner
Ankara Etlik City Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 29, 2023
First Posted
November 2, 2023
Study Start
June 10, 2024
Primary Completion
August 2, 2024
Study Completion
August 15, 2024
Last Updated
May 4, 2025
Record last verified: 2025-05