Spine SurgeryNCT05131854
Incidence , Risk Factors and Outcomes of Haemodynamic Instability and Cardiac Arrest During Spine Surgery
An observational study of Spine Surgery, run by Zagazig University at 1 site in Egypt.
Trial summary
Risk factors for cardiac arrest during spine surgery have been well defined, including lumbar fusion, age over 65 years, obesity, cardiovascular disease, ethnicity and ASA status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Surgery
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Nov 2021to 31 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
- Adult, Older adult
Study population: population candidated for spine surgery
Who may be able to join
- Aged more than 18
- Gender: both.
- ASA grade I-II (American society of anesthiologists).
- Prepared to spine surgery under general anesthesia
Who cannot join
- Ischemic heart patients
- Hypertensive patients
- Patients with atrial fibrillation or any previous history of attack of arrhythmias
- Patients on B.B ( beta-blockers)
- Chronic use of neuropsychiatric medications
- Renal Impairment
Show all 9Show fewer
- Liver Dysfunction.
- Any complications during the procedure as massive hemorrhage
- Surgery for traumatic spinal cord
Trial locations and contacts
1 site in 1 country.
Essam youssef contact
Egypt1 site, 1 recruiting
- Recruiting
Zagazig university
Zagazig
zagazig university
About this study
Risk factors for cardiac arrest during spine surgery have been well defined, including lumbar fusion, age over 65 years, obesity, cardiovascular disease, ethnicity and ASA status. Bradycardia and asystole have been described under general anaesthesia in combined surgical cohorts: Proposed mechanisms include unopposed parasympathetic activation, enhanced vasovagal response to decreased venous return, and psychiatric stressors. The investigators prospectively will review patients candidates for spine surgery to explore potential incidence, contributory factors and outcomes to unexpected transient intraoperative haemodynamic instability, arrhythmia, and cardiac arrest during spine surgery as these data are needed to aid risk stratification and improve decision making for spine care teams.
- Conditions
- Spine Surgery
- Keywords
- spine surgery , bradycardia , cardiac arrest
- Medical subject headings
- Bradycardia, Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Haemodynamic Instability during Spine Surgery
To calculate Incidence of Haemodynamic Instability during Spine Surgery
Measured: allover one year
Risk factors of Haemodynamic Instability during Spine Surgery
To analyze risk factors of Haemodynamic Instability during Spine Surgery
Measured: allover one year
outcomes of Haemodynamic Instability during Spine Surgery
To calculate the rate of mortality of Haemodynamic Instability during Spine Surgery
Measured: allover one year
Incidence of cardiac arrest during Spine Surgery
To calculate Incidence of cardiac arrest during Spine Surgery
Measured: allover one year
Risk factors of cardiac arrest during Spine Surgery
To analyze risk factors of cardiac arrest during Spine Surgery
Measured: allover one year
outcomes of Cardiac Arrest during Spine Surgery
To calculate the rate of mortality of cardiac arrest during Spine Surgery
Measured: allover one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start25 Nov 2021
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine SurgeryStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Essamedin Mamdouh Negm, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131854
- Sponsor's protocol ID
- 8078-13-10-2021
- Status last verified
- Feb 2022
- First submitted
- 15 Oct 2021
- Last updated
- 10 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence , Risk Factors and Outcomes of Haemodynamic Instability and Cardiac Arrest During Spine Surgery
- ClinicalTrials.gov ID
- NCT05131854
- Acronym / sponsor ID
- 8078-13-10-2021
- Conditions
- Spine Surgery
- Keywords
- spine surgery , bradycardia , cardiac arrest
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 23 Nov 2021 (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.
Risk factors for cardiac arrest during spine surgery have been well defined, including lumbar fusion, age over 65 years, obesity, cardiovascular disease, ethnicity and ASA status. Bradycardia and asystole have been described under general anaesthesia in combined surgical cohorts: Proposed mechanisms include unopposed parasympathetic activation, enhanced vasovagal response to decreased venous return, and psychiatric stressors. The investigators prospectively will review patients candidates for spine surgery to explore potential incidence, contributory factors and outcomes to unexpected transient intraoperative haemodynamic instability, arrhythmia, and cardiac arrest during spine surgery as these data are needed to aid risk stratification and improve decision making for spine care teams.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- population candidated for spine surgery
Key inclusion criteria (4 listed)
- Aged more than 18
- Gender: both.
- ASA grade I-II (American society of anesthiologists).
- Prepared to spine surgery under general anesthesia
Key exclusion criteria (9 listed)
- Ischemic heart patients
- Hypertensive patients
- Patients with atrial fibrillation or any previous history of attack of arrhythmias
- Patients on B.B ( beta-blockers)
- Chronic use of neuropsychiatric medications
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
Incidence of Haemodynamic Instability during Spine Surgery
Time frame: allover one year
To calculate Incidence of Haemodynamic Instability during Spine Surgery
Risk factors of Haemodynamic Instability during Spine Surgery
Time frame: allover one year
To analyze risk factors of Haemodynamic Instability during Spine Surgery
outcomes of Haemodynamic Instability during Spine Surgery
Time frame: allover one year
To calculate the rate of mortality of Haemodynamic Instability during Spine Surgery
Incidence of cardiac arrest during Spine Surgery
Time frame: allover one year
To calculate Incidence of cardiac arrest during Spine Surgery
Risk factors of cardiac arrest during Spine Surgery
Time frame: allover one year
To analyze risk factors of cardiac arrest during Spine Surgery
outcomes of Cardiac Arrest during Spine Surgery
Time frame: allover one year
To calculate the rate of mortality of cardiac arrest during Spine Surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
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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.
Essam youssef contact
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 Spine Surgery, run by Zagazig University at 1 site in Egypt.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 10 Mar 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Essamedin Negm, MD (0021098123058, alpherdawss@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Haemodynamic Instability during Spine Surgery (time frame: allover one year). The study lists 6 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 10 Mar 2022.