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NCT Number: NCT06114277

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

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.

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Key information

Conditions

Pain, Postoperative Nausea Nausea, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting Vomiting, Postoperative

Age range

18 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

Ankara Etlik City Hospital

Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, 06170, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

ETCO2 levels

Other

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

Other names: Patients with low ETCO2 levels

Patients with high ETCO2 levels

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pain on the Numeric Rating Scale (NRS)

    Time frame: 0-2-4-8-12-24 hours postoperatively

    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.

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

The Relationship Between Intraoperative ETCO2 Levels and Postoperative Pain and Nausea-Vomiting in Laparoscopic Robotic Prostatectomy Patients

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 2, 2023
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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