Integrated Pulmonary Index in Gastroscopic Procedures

NCT05829486 | Unknown

• 1 other identifier: 147/22
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoscopy

Keywords

sedation; respiratory complications; ambulatory anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ketaprop

At the beginning of anesthesia, 0.25 mg/kg ketamine and 0.75 mg/kg propofol will be administered.

Procedure: gastroscopy

remiprop

At the beginning of anesthesia, 1 mcg/kg of remifentanil and 0.75 mg/kg propofol will be administered.

Procedure: gastroscopy

Interventions

gastroscopy PROCEDURE

anaesthetic management of ambulatory endoscopic procedures

ketaprop; remiprop

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

over the age of 18 who will undergo endoscopic intervention

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpaşa TREH

Istanbul, Gaziosmanpaşa, 34255, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Gastroscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• zuhal çavuş, MD

  gaziosmanpasa TREH

  PRINCIPAL INVESTIGATOR

• döndü genç moralar, MD

  gaziosmanpasa TREH

  STUDY DIRECTOR

Central Study Contacts

sibel bektas, MD

CONTACT

02129453030; sibel-bektas@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, principal investigator

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 25, 2023
• Study Start: February 6, 2023
• Primary Completion: September 30, 2023
• Study Completion: November 5, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08

Locations

TU (1)