The Relationship Between Intraoperative ETCO2 Levels and Postoperative Pain and Nausea-Vomiting

NCT ID: NCT06114277

Last Updated: 2025-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-10

Study Completion Date

2024-08-15

Brief Summary

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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

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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.

Conditions

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Pain, Postoperative Nausea, Postoperative Vomiting, Postoperative

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with low ETCO2 levels

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

ETCO2 levels

Intervention Type OTHER

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

Patients with high ETCO2 levels

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

Patients with high ETCO2 levels

Intervention Type OTHER

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

Interventions

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ETCO2 levels

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

Intervention Type OTHER

Patients with high ETCO2 levels

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

Intervention Type OTHER

Other Intervention Names

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Patients with low ETCO2 levels

Eligibility Criteria

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Inclusion Criteria

1. Individuals between the ages of 18 and 80.
2. Patients with American Society of Anesthesiologists (ASA) scores I, II, or III.
3. Patients who have undergone robotic laparoscopic prostatectomy in the operating room.

Exclusion Criteria

1. Patients under 18 years old or over 80 years old.
2. Patients with American Society of Anesthesiologists (ASA) scores IV and above.
3. Patients who refuse to participate in the study.
4. Patients undergoing emergency surgery.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Yusuf Özgüner

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yusuf Ozguner

Role: PRINCIPAL_INVESTIGATOR

Ankara Etlik City Hospital

Locations

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Ankara Etlik City Hospital

Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 30938121 (View on PubMed)

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.

Reference Type RESULT
PMID: 33045886 (View on PubMed)

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.

Reference Type RESULT
PMID: 28389799 (View on PubMed)

Other Identifiers

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AnkaraEtlikYusufOzguner005

Identifier Type: -

Identifier Source: org_study_id

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