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

NCT06865378 | Enrolling By Invitation

• 1 other identifier: KAEK/2021.02.62
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Postoperative Nausea and Vomiting; Postoperative Pain, Acute; End Tidal Carbon Dioxide; Perfusion Index and Pleth Variability Index

Outcome Measures

Primary Outcomes (1)

• Investigation of the incidence of postoperative nausea, vomiting and pain

  From enrollment to postoperative 1st week

Study Arms (3)

Arm Hypocarbia

Procedure: Carbon dioxide (CO2) gas insufflation

Arm normocarbia

Procedure: Carbon dioxide (CO2) gas insufflation

Arm hypercarbia

Procedure: Carbon dioxide (CO2) gas insufflation

Interventions

Carbon dioxide (CO2) gas insufflation PROCEDURE

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 Hypocarbia; Arm hypercarbia; Arm normocarbia

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Naime Yalçın: lead

Study Sites (1)

Sağlık Bilimleri Üniversitesi Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Pain, Postoperative

Interventions

Carbon Dioxide

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Carbon Compounds, Inorganic; Inorganic Chemicals; Gases; Oxides; Oxygen Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist Anesthesiology and Reanimation, Principal Investigator

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 7, 2025
• Study Start: March 15, 2021
• Primary Completion: December 15, 2025
• Study Completion: December 31, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

TU (1)