Clinical trial NCT05563727: Sedation-related Complications During Gastroenterological Procedures
Official title: Prospective Evaluation of Sedation-related Complications During Gastroenterological Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Anesthesia
Sedation-related Complications
Keywords: sedation
gastroenterolojical procedure
complication
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 693
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The relationship between different anesthetic drugs and complications will be investigated
timeFrame: 8 months
measure: The relationship between comorbidities and complications
timeFrame: 8 months
Secondary outcomes:
measure: Incidence of sedation related complications in gastroenterology unit
timeFrame: 8 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University School of Medicine
Study officials:
affiliation: Gazi Üniversitesi Tıp Fakültesi
name: Selin Erel
role: PRINCIPAL_INVESTIGATOR
References: