Clinical trial NCT05829486: Integrated Pulmonary Index in Gastroscopic Procedures
Official title: The Effects of Ketamine and Propofol and Remifentanil and Propofol Combinations on Integrated Pulmonary Index During Sedation in Gastroscopy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endoscopy
Keywords: sedation
respiratory complications
ambulatory anesthesia
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2023-04-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: over the age of 18 who will undergo endoscopic intervention

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: respiratory complications comparing different sedative groups
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpaşa TREH
state: Gaziosmanpaşa
Study officials:
affiliation: gaziosmanpasa TREH
name: zuhal çavuş, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: gaziosmanpasa TREH
name: döndü genç moralar, MD
role: STUDY_DIRECTOR
References: