Clinical trial NCT06114277: The Relationship Between Intraoperative ETCO2 Levels and Postoperative Pain and Nausea-Vomiting
Official title: The Relationship Between Intraoperative ETCO2 Levels and Postoperative Pain and Nausea-Vomiting in Laparoscopic Robotic Prostatectomy Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Nausea, Postoperative
Vomiting, Postoperative
Keywords: End-tidal carbon dioxide
Laparoscopic Robotic Prostatectomy
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2023-11-02
Enrollment: 109
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative nausea and vomiting (PONV) Score
timeFrame: 0-2-4-8-12-24 hours postoperatively
Secondary outcomes:
measure: Pain on the Numeric Rating Scale (NRS)
timeFrame: 0-2-4-8-12-24 hours postoperatively
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
state: Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle
Study officials:
affiliation: Ankara Etlik City Hospital
name: Yusuf Ozguner
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.