NCT06114277

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

June 10, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2024

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
Last Updated

May 4, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

October 29, 2023

Last Update Submit

May 1, 2025

Conditions

Keywords

End-tidal carbon dioxideLaparoscopic Robotic Prostatectomy

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.

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.

Other: Patients with high ETCO2 levels

Interventions

Intraoperative ETCO2 values between 26 and 35 in laparoscopic robotic prostatectomy patients were included in group 1.

Also known as: Patients with low ETCO2 levels
Patients with low ETCO2 levels

Intraoperative ETCO2 values between 36 and 45 in laparoscopic robotic prostatectomy patients were included in group 2.

Patients with high ETCO2 levels

Eligibility Criteria

Age18 Years - 80 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsRobotic prostate surgery is a procedure performed on male patients.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

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)

Location

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.

  • Besir 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.

  • Son 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.

MeSH Terms

Conditions

Pain, PostoperativePostoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNauseaSigns and Symptoms, DigestiveVomiting

Study Officials

  • Yusuf Ozguner

    Ankara Etlik City Hospital

    PRINCIPAL INVESTIGATOR

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

Locations