Integrated Pulmonary Index in Gastroscopic Procedures

The Effects of Ketamine and Propofol and Remifentanil and Propofol Combinations on Integrated Pulmonary Index During Sedation in Gastroscopy

Various complications are the leading cause of morbidity in sedation practices in endoscopic procedures, and guidelines recommend continuous monitoring of circulation, respiratory function, and ventilation. Integrated Pulmonary Index (IPI), one of the methods that can be used in this monitoring, gives a single numerical value obtained by continuous and simultaneous joint mathematical analysis of Oxygen saturation, End-tidal carbon dioxide concentration, respiratory rate, and heart rate values and is a good monitorization in these interventions. and provides tracking. In this study, the aim is to determine the role of IPI in the diagnosis and follow-up of respiratory complications in patients who were sedated during gastroscopy procedures.

Study Overview

• Status: Recruiting
• Conditions: Endoscopy
• Intervention / Treatment: Procedure: gastroscopy

Detailed Description

IPI EtCO2 is a monitoring method consisting of respiratory rate, SPO2 and heart rate parameters. While EtCO2 is measured with nasal capnography, SPO2, heart rate, respiratory rate are measured with finger probe and it will show instant measurement of respiratory status. IPI takes values between 1-10. An IPI value of 8 and above will indicate normal values, a value between 5-7 will indicate that the respiratory status of the patient should be carefully examined and intervened if necessary, values of 4 and below will definitely indicate that the patient's respiratory status should be intervened.

Blood pressure measurement will be made with a sphingmomanometer noninvasively at certain time intervals with the help of a cuff that will be placed on the patient's arm area.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: sibel bektas, MD; Phone Number: 02129453030; Email: sibel-bektas@yahoo.com

Study Locations

• Turkey
  • Gaziosmanpaşa
    • Istanbul, Gaziosmanpaşa, Turkey, 34255
      • Recruiting
      • Gaziosmanpaşa TREH
      • Contact: sibel bektaş, prof.MD; Email: sibel-bektas@yahoo.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

over the age of 18 who will undergo endoscopic intervention

Description

Inclusion Criteria:

• ASA 1-2-3 risk scored patients,
• patients over the age of 18 who will undergo endoscopic intervention

Exclusion Criteria:

• Patients who need mechanical ventilator support,
• patients who need emergency endoscopic intervention,
• patients with a history of substance abuse,
• patients with a history of allergy to the drugs to be used,
• pregnant women will be excluded from the study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ketaprop; At the beginning of anesthesia, 0.25 mg/kg ketamine and 0.75 mg/kg propofol will be administered.	Procedure: gastroscopy; anaesthetic management of ambulatory endoscopic procedures
remiprop; At the beginning of anesthesia, 1 mcg/kg of remifentanil and 0.75 mg/kg propofol will be administered.	Procedure: gastroscopy; anaesthetic management of ambulatory endoscopic procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
respiratory complications comparing different sedative groups	Comparison of sedation safety and efficacy of Ketamine and Propofol and Remifentanil and Propofol administration to be applied to patients in endoscopy by using integrated pulmonary index (1-10)	Measurements will be in 4 time frames; before induction anesthesia, 5 minutes after the induction of sedation, 10 minutes after the induction, 5 minutes after the end of the procedure

Collaborators and Investigators

• Sponsor: Gaziosmanpasa Research and Education Hospital
• Investigators: Principal Investigator: zuhal çavuş, MD, Gaziosmanpaşa TREH; Study Director: döndü genç moralar, MD, Gaziosmanpaşa TREH

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): November 5, 2023

Study Registration Dates

• First Submitted: March 31, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: sedation; respiratory complications; ambulatory anesthesia
• Other Study ID Numbers: 147/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No