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Clinical Trials/NCT06114277
NCT06114277
Completed
Not Applicable

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

Ankara Etlik City Hospital1 site in 1 country109 target enrollmentJune 10, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Postoperative
Sponsor
Ankara Etlik City Hospital
Enrollment
109
Locations
1
Primary Endpoint
Postoperative nausea and vomiting (PONV) Score
Status
Completed
Last Updated
12 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 10, 2024
End Date
August 15, 2024
Last Updated
12 months ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
Ankara Etlik City Hospital
Responsible Party
Principal Investigator
Principal Investigator

Yusuf Özgüner

Principal Investigator

Ankara Etlik City Hospital

Eligibility Criteria

Inclusion Criteria

  • Individuals between the ages of 18 and
  • 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.

Outcomes

Primary Outcomes

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

  • Pain on the Numeric Rating Scale (NRS)(0-2-4-8-12-24 hours postoperatively)

Study Sites (1)

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