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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06114277
• Other study ID #: AnkaraEtlikYusufOzguner005
• Status: Recruiting
• Start date: November 10, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2024
• Source: Ankara Etlik City Hospital
• Contact: Yusuf Ozguner
• Phone: 05427150725
• Email: y.ozguner[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nausea
• Nausea, Postoperative
• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Vomiting
• Vomiting, Postoperative

Intervention

Other:
• ETCO2 levels
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 group 2.

Locations

Country	Name	City	State
Turkey	Ankara Etlik City Hospital	Ankara	Varlik Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Etlik City Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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 Analge — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative nausea and vomiting (PONV) Score	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	Pain on the Numeric Rating Scale (NRS)	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