Complication of AnesthesiaNCT05563727
Sedation-related Complications During Gastroenterological Procedures
An observational study of Complication of Anesthesia and Sedation-related Complications, run by Gazi University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Complication of Anesthesia, Sedation-related Complications
- How many people
- 693 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2021to 28 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- All patients who agree to participate in the study will be included
- Patients who will be sedated for an elective procedure in gastroenterology
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University School of Medicine
Ankara, 06500
About this study
Official title: Prospective Evaluation of Sedation-related Complications During Gastroenterological Procedures
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.
Read the 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.
- Keywords
- sedation, gastroenterolojical procedure, complication
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 months
Secondary outcomes (1)
Incidence of sedation related complications in gastroenterology unit
All the complications will be recorded and the most common ones will be revealed.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start25 Dec 2021
- Primary completion25 Dec 2022
- Study completion28 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of AnesthesiaStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 693 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selin Erel, Gazi University
- Investigators
- Selin Erel, Principal investigator, Gazi Üniversitesi Tıp Fakültesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563727
- Sponsor's protocol ID
- 238(23.12.2021)
- Status last verified
- Mar 2025
- First submitted
- 29 Aug 2022
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the data is collected and statistically analyzed, the study will be shared with the literature as an article
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Sedation-related Complications During Gastroenterological Procedures
- ClinicalTrials.gov ID
- NCT05563727
- Acronym / sponsor ID
- 238(23.12.2021)
- Keywords
- sedation, gastroenterolojical procedure, complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 693 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 25 Dec 2021 (actual)
- Primary completion
- 25 Dec 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- All patients who agree to participate in the study will be included
- Patients who will be sedated for an elective procedure in gastroenterology
Key exclusion criteria (7 listed)
- pediatric patients (<18 years)
- who did not want to participate in the study
- mentally retarded patients
- language problems (not knowing turkish)
- emergent interventions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The relationship between different anesthetic drugs and complications will be investigated
Time frame: 8 months
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.
The relationship between comorbidities and complications
Time frame: 8 months
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.
1 secondary outcome
Incidence of sedation related complications in gastroenterology unit
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: Yes. After the data is collected and statistically analyzed, the study will be shared with the literature as an article
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selin Erel principal investigator
Gazi Üniversitesi Tıp Fakültesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication of Anesthesia and Sedation-related Complications, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between different anesthetic drugs and complications will be investigated (time frame: 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.