Obesity and Obesity-related Medical ConditionsNCT07034001
Effect of Anesthesia on Frontal QRS t Angle in Obese Individuals
An observational study of Obesity and Obesity-related Medical Conditions, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this observational study is to determine the effect of anesthesia on frontal qrs-t angle changes in obese individuals. To learn the long-term effects of intervention A in individuals with a body mass index > 30 who received intervention A. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 10 May 2025
- How long will I take part?
- 1 Day
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People between the ages of 18-65 who underwent laparoscopic cholecystectomy surgery
Who may be able to join
- People between the ages of 18-65 who underwent laparoscopic cholecystectomy surgery
Who cannot join
- known coronary artery disease, atrial fibrillation, heart failure, liver failure, kidney failure, preexcitation syndromes, electrolyte disorders, use of drugs that prolong the QT interval, respiratory failure and metabolic diseases were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Anesthesia on Frontal QRS-T Angle in Obese Individuals
The aim of this observational study is to determine the effect of anesthesia on frontal qrs-t angle changes in obese individuals. To learn the long-term effects of intervention A in individuals with a body mass index > 30 who received intervention A. The main question it aims to answer is:
Does frontal qrs-t angle change occur in obese individuals due to anesthesia? Preoperative and intraoperative ECG changes of individuals undergoing surgery will be examined.
Read the detailed description
All patients were routinely administered 500 cc of Ringer's lactated solution intravenously (IV) before anesthesia and taken to the operating room. The body mass index will be calculated according to the formula body weight kg / height cm2. Obese patients with a BMI above 30 kg/m2 were recorded as group 2, and non-obese patients with a BMI below <30 kg/m2 were recorded as group 1. Patients were taken to the operating room and routine ECG, noninvasive blood pressure, pulse, and oxygen saturation monitoring (CARESCAPE™ B650, GE Healthcare, USA) was performed. All patients were hydrated intravenously (IV) with 500 cc of Ringer's lactated solution after a 6-hour fast. For premedication, midazolam 1 mg IV and pantoprazole 40 mg IV were administered. For anesthesia induction, propofol 2 mg/kg, fentanyl 2 mg/kg and rocuronium 0.6 mg/kg were administered intravenously.
- Keywords
- obesity, frontal qrs-t angle
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BMI>30 | BMI>30 | |
| BMI<30 | BMI<30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
EKG
Frontal qrs t angle and qt interval examination on ecg
Measured: 1 day
Frontal qrs-t angle
Frontal qrs t angle examination on ecg
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Dec 2024
- Primary completion30 Apr 2025
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harun Tolga Duran, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034001
- Sponsor's protocol ID
- htdekg
- Status last verified
- Jun 2025
- First submitted
- 15 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: single-center study
Publications
Kaya A, Karahan MA, Bingol Tanriverdi T, Esercan A, Bostanci Erkmen M, Tanriverdi Z. Comparison of the Effects of Spinal Anaesthesia on Frontal QRS-T Angle in Term and Post-Term Pregnancies Planned for Elective Caesarean Section: A Prospective Study. Medicina (Kaunas). 2025 May 19;61(5):919. doi: 10.3390/medicina61050919.
PubMed 40428877
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anesthesia on Frontal QRS-T Angle in Obese Individuals
- ClinicalTrials.gov ID
- NCT07034001
- Acronym / sponsor ID
- htdekg
- Keywords
- obesity, frontal qrs-t angle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 24 Jun 2025 (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.
The aim of this observational study is to determine the effect of anesthesia on frontal qrs-t angle changes in obese individuals. To learn the long-term effects of intervention A in individuals with a body mass index > 30 who received intervention A. The main question it aims to answer is:
Does frontal qrs-t angle change occur in obese individuals due to anesthesia? Preoperative and intraoperative ECG changes of individuals undergoing surgery will be examined.
Detailed description
All patients were routinely administered 500 cc of Ringer's lactated solution intravenously (IV) before anesthesia and taken to the operating room. The body mass index will be calculated according to the formula body weight kg / height cm2. Obese patients with a BMI above 30 kg/m2 were recorded as group 2, and non-obese patients with a BMI below <30 kg/m2 were recorded as group 1. Patients were taken to the operating room and routine ECG, noninvasive blood pressure, pulse, and oxygen saturation monitoring (CARESCAPE™ B650, GE Healthcare, USA) was performed. All patients were hydrated intravenously (IV) with 500 cc of Ringer's lactated solution after a 6-hour fast. For premedication, midazolam 1 mg IV and pantoprazole 40 mg IV were administered. For anesthesia induction, propofol 2 mg/kg, fentanyl 2 mg/kg and rocuronium 0.6 mg/kg were administered intravenously.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMI>30 | – | –BMI>30 |
| BMI<30 | – | –BMI<30 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People between the ages of 18-65 who underwent laparoscopic cholecystectomy surgery
Key inclusion criteria (1 listed)
- People between the ages of 18-65 who underwent laparoscopic cholecystectomy surgery
Key exclusion criteria (1 listed)
- known coronary artery disease, atrial fibrillation, heart failure, liver failure, kidney failure, preexcitation syndromes, electrolyte disorders, use of drugs that prolong the QT interval, respiratory failure and metabolic diseases were excluded from the study
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
EKG
Time frame: 1 day
Frontal qrs t angle and qt interval examination on ecg
Frontal qrs-t angle
Time frame: 1 day
Frontal qrs t angle examination on ecg
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 24 Jun 2025.
- Results publication: PubMed 40428877Kaya A, Karahan MA, Bingol Tanriverdi T, Esercan A, Bostanci Erkmen M, Tanriverdi Z. Comparison of the Effects of Spinal Anaesthesia on Frontal QRS-T Angle in Term and Post-Term Pregnancies Planned for Elective Caesarean Section: A Prospective Study. Medicina (Kaunas). 2025 May 19;61(5):919. doi: 10.3390/medicina61050919.
- Individual participant dataSharing planned: No. single-center study
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Obesity and Obesity-related Medical Conditions, run by Amasya 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 1 inclusion and 1 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 24 Jun 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?
EKG (time frame: 1 day). 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?
On the ClinicalTrials.gov record for NCT07034001, which also lists 1 linked publication.
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 24 Jun 2025.