Sedation-related Complications During Gastroenterological Procedures

NCT05563727 | Completed

• 1 other identifier: 238(23.12.2021)
• Study Type: observational
• Target: 693
• Locations: 1 country
• Sites: 1

Brief Summary

Applications of non-operating room anesthesia for diagnosis and treatment are required in a variety of disciplines nowadays. Although it is not painful, sedation may be required in the gastrointestinal unit during procedures that put the patient through discomfort and stress, in order to reduce anxiety and provide analgesia. The purpose of this study is to evaluate the sedation used in our hospital's gastrointestinal endoscopy unit in light of intraoperative hemodynamic variables and perioperative problems. There are studies about non-operating room anesthesia in the literature, but there aren't many of them in our country, and none of them include a number of participants. The size of this study will exceed any study in Turkey.

Conditions

Complication of Anesthesia; Sedation-related Complications

Keywords

sedation; gastroenterolojical procedure; complication

Outcome Measures

Primary Outcomes (2)

• The relationship between different anesthetic drugs and complications will be investigated

  During gastroenterological procedures, drugs such as propofol, ketamine, fentanyl, lidocaine, and midazolam are used in different combinations. Which anesthetic medicines induce complications like hypertension, hypotension, hypoxia, apnea, bradycardia, nausea, vomiting, and agitation to be more noticeable will be investigated in our study. Hypertension is defined as an elevation in blood pressure more than 20% compared to perioperative values. Hypotension is defined as degradation in blood pressure more than 20% compared to perioperative values. Bradycardia is defined as less than 50 heartbeats per minute. Peripheral oxygen saturation below 90 will be referred to as hypoxia. Apnea is defined as "no respiratory effort for more than 20 seconds" or "a halt of breathing for more than 10 seconds. For statistical analyses, a binomial logistic regression model will be established to determine the risk factors for complications according to drug type and complications.

  8 months

• The relationship between comorbidities and complications

  Patients who will undergo a gastroenterological procedure may have different comorbidities such as hypertension, chronic arterial disease, diabetes, COPD, and chronic kidney disease. We want to investigate which comorbidities are more likely to result in particular complications in our study. For statistical analyses, a binomial logistic regression model will be established to determine the risk factors for complications according to comorbidities.

  8 months

Secondary Outcomes (1)

• Incidence of sedation related complications in gastroenterology unit

  8 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients participating in the study will be required to sign a voluntary consent form. Patients who will undergo gastroenterological intervention (such as will be included. endoscopy, colonoscopy, endocolon, endoscopic ultrasonography, endoscopic submucosal dissection, endoscopic retrograde cholangiopancreatography) in a single central gastroenterology intervention unit in our hospital.

You may qualify if:

• All patients who agree to participate in the study will be included
• Patients who will be sedated for an elective procedure in gastroenterology

You may not qualify if:

• pediatric patients (\<18 years)
• who did not want to participate in the study
• mentally retarded patients
• language problems (not knowing turkish)
• emergent interventions
• allergy to the anesthetics
• need for endotracheal intubation or general anesthesia

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University School of Medicine

Ankara, 06500, Turkey (Türkiye)

Location

Study Officials

• Selin Erel

  Gazi Üniversitesi Tıp Fakültesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Anesthesiologist in Gazi University School of Medicine

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: October 3, 2022
• Study Start: December 25, 2021
• Primary Completion: December 25, 2022
• Study Completion: December 28, 2022
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 1 year

Locations

TU (1)