Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05563727 |
Other study ID # |
238(23.12.2021) |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
December 25, 2021 |
Est. completion date |
October 25, 2022 |
Study information
Verified date |
September 2022 |
Source |
Gazi University |
Contact |
selin erel |
Phone |
+905052947275 |
Email |
selinerel[@]yahoo.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
Description:
All patients will be informed about the study before the gastroenterological procedure and
the consent form will be signed by the patients who want to participate in the study.
Demographic data of patients (age, weight, height), ASA (American Society of
Anesthesiologists) classification, allergies, comorbidities (hypertension, coronary artery
disease, chronic kidney disease, COPD), Mallampati scores, history of covid, history of covid
vaccine, and history of previous anesthesia will be questioned and recorded before the
gastroenterological procedure. Afterward, participants will be taken to the gastroenterology
intervention room and standard monitorisation (Electrocardiogram, noninvasive blood pressure,
peripheral oxygen saturation, and end-tidal CO2) will be performed. The measurements will be
repeated every 5 minutes following the induction of anesthesia and recorded. Administered
anesthetics and their doses at the induction and maintenance of sedation will be recorded.
The person recording the data will not be the patient's primary anesthesiologist. The data
will be recorded by a second anesthesiologist who will not interfere with the medical
treatment and management of the patient. The presence of perioperative and postoperative
complications (such as hypotension, hypertension, bradycardia, apnea, hypoxia, agitation,
postoperative nausea and vomiting) will be observed by the second anesthesiologist and
recorded. 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. There will be no intervention for the patients. Patients will not be divided
into groups or randomized. The data will be recorded by an impartial observer.