The Correlation Between Intraoperative End Tidal Carbon Dioxide, Perfusion Index and Pulse Variability Index on Postoperative Nausea Vomiting and Pain

The Correlation Between Intraoperative End Tidal Carbon Dioxide, Perfusion Index and Pulse Variability Index on Postoperative Nausea Vomiting and Pain; Prospective Study

Postoperative pain, which is frequently encountered in laparoscopic operations, has been examined in different studies with end tidal CO2 (end tidal carbon dioxide), total insufflated gas amount and PI (Perfusion index) parameters. PONV (postoperative nausea and vomiting), which is encountered more frequently than pain in the postoperative period, has been examined in relation to end tidal CO2. In this study, it was aimed to evaluate the development of postoperative pain and PONV, which affect recovery and patient comfort, by comparing the relationship between end tidal CO2, PI and PVI (Pulse variability index).

Study Overview

• Status: Enrolling by invitation
• Conditions: Postoperative Nausea and Vomiting; Postoperative Pain, Acute; End Tidal Carbon Dioxide; Perfusion Index and Pleth Variability Index
• Intervention / Treatment: Procedure: Carbon dioxide (CO2) gas insufflation

Detailed Description

In recent years, laparoscopic gynecologic surgery has become a preferred technique over traditional open surgery due to its benefits such as better cosmetic results, lower risk of bleeding, minimally invasive surgery, lower postoperative pain and incidence of wound infection, and as a result, earlier discharge.

PI (Perfusion index), the ratio of alternating current component to direct current component, is a representation of the photoplethysmography waveform that quantitatively reflects real-time changes in peripheral blood flow in the monitored region. PVI (Pulse variability index) is another dynamic index and many studies have concluded that it is useful in assessing fluid responsiveness in patients. However, there are still uncertainties in the study regarding the effect of pneumoperitoneum on PVI. PVI, calculated from respiratory variations in perfusion index, has been shown to predict fluid responsiveness in mechanically ventilated patients; however, vasomotor tone changes induced by hypercapnia may affect PI and therefore reduce the accuracy of PVI.

Artificial pneumoperitoneum, which is commonly used in laparoscopic procedures and created with the Trendelenburg position and CO2 (carbon dioxide) insufflation, frequently leads to physiological changes such as PONV (postoperative nausea and vomiting) and pain. Although the mechanisms underlying its development are still unclear, PONV is caused by dopamine and serotonin released as a result of ischemia in the brain and intestinal tract, stimulating the medullary vomiting center. Therefore, ischemia has been shown to be one of the important factors for PONV. Hypocapnia is known to be associated with decreased cardiac output, and increased systematic vascular resistance can reduce blood flow in the brain and intestinal tract. Therefore, this study concluded that intraoperative hypocapnia may increase the risk of PONV. Another study reported that CO2 is a strong vasodilator and that intraoperative hypercarbia may be associated with increased perfusion to regions effective for PONV, including the brain and gastrointestinal tract. In a study examining the relationship between PI and postoperative pain, it was stated that there was a decrease in PI due to the activation of the sympathetic nervous system by pain, contraction in peripheral blood vessels and an increase in vasomotor tone, and an increase in PI values after the use of analgesics.

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey, 34000
    • Sağlık Bilimleri Üniversitesi Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

A prospective, randomized, controlled study was initiated at Kanuni Sultan Süleyman E.A.H. to measure the carbon dioxide changes that develop during laparoscopic operations with non-invasive monitoring, to evaluate the correlation between them, and to investigate their effects on postoperative pain and nausea and vomiting.

Description

Inclusion Criteria:

• Planned for elective total laparoscopic hysterectomy
• 20-65 years old
• ASA I - II

Exclusion Criteria:

• history of intracranial disease
• lung disease
• systemic hypertension
• ischemic heart disease
• history of postoperative nausea and vomiting in previous operations
• smoking habit
• motion sickness
• liver and kidney dysfunction
• abnormal fluid-electrolyte balance
• preoperative use of antiemetic drugs
• severe heart failure
• ASA III and above
• body mass index> 35 kg m2

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm Hypocarbia	Procedure: Carbon dioxide (CO2) gas insufflation; Artificial pneumoperitoneum created by the Trendelenburg position and carbon dioxide (CO2) insufflation, which is widely used in laparoscopic procedures, frequently leads to physiological changes such as postoperative nausea and vomiting (PONV) and pain. Therefore, the currently limited usable parameters PI and PVI will be evaluated in correlation with end tidal CO2 in continuous monitoring.
Arm normocarbia	Procedure: Carbon dioxide (CO2) gas insufflation; Artificial pneumoperitoneum created by the Trendelenburg position and carbon dioxide (CO2) insufflation, which is widely used in laparoscopic procedures, frequently leads to physiological changes such as postoperative nausea and vomiting (PONV) and pain. Therefore, the currently limited usable parameters PI and PVI will be evaluated in correlation with end tidal CO2 in continuous monitoring.
Arm hypercarbia	Procedure: Carbon dioxide (CO2) gas insufflation; Artificial pneumoperitoneum created by the Trendelenburg position and carbon dioxide (CO2) insufflation, which is widely used in laparoscopic procedures, frequently leads to physiological changes such as postoperative nausea and vomiting (PONV) and pain. Therefore, the currently limited usable parameters PI and PVI will be evaluated in correlation with end tidal CO2 in continuous monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Investigation of the incidence of postoperative nausea, vomiting and pain	From enrollment to postoperative 1st week

Collaborators and Investigators

• Sponsor: Naime Yalçın

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Estimated): December 15, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 20, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Pain, Postoperative; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: KAEK/2021.02.62

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes