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

November 2, 2023 updated by: Yusuf Özgüner, Ankara Etlik City Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with low ETCO2 levels
Intraoperative ETCO2 values between 26 and 34 in laparoscopic robotic prostatectomy patients were included in this group.
Other: ETCO2 levels
Intraoperative ETCO2 values between 26 and 34 in laparoscopic robotic prostatectomy patients were included in group 1.
Other Names:
  • Patients with low ETCO2 levels
Patients with high ETCO2 levels
Intraoperative ETCO2 values between 35 and 45 in laparoscopic robotic prostatectomy patients were included in this group.
Other: Patients with high ETCO2 levels
Intraoperative ETCO2 values between 35 and 45 in laparoscopic robotic prostatectomy patients were included in group 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0-2-4-8-12-24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0-2-4-8-12-24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Etlik City Hospital

Investigators

  • Principal Investigator: Yusuf Ozguner, Ankara Etlik City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 10, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

October 29, 2023

First Submitted That Met QC Criteria

October 29, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AnkaraEtlikYusufOzguner005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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