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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05131854
Other study ID # 8078-13-10-2021
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 25, 2021
Est. completion date December 31, 2022

Study information

Verified date February 2022
Source Zagazig University
Contact Essamedin Negm, MD
Phone 0021098123058
Email alpherdawss@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2022
Est. primary completion date October 31, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Aged more than 18 2. Gender: both. 3. ASA grade I-II (American society of anesthiologists). 4. Prepared to spine surgery under general anesthesia Exclusion Criteria: 1. Ischemic heart patients 2. Hypertensive patients 3. Patients with atrial fibrillation or any previous history of attack of arrhythmias 4. Patients on B.B ( beta-blockers) 5. Chronic use of neuropsychiatric medications 6. Renal Impairment 7. Liver Dysfunction. 8. Any complications during the procedure as massive hemorrhage 9. Surgery for traumatic spinal cord

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Zagazig university Zagazig

Sponsors (1)

Lead Sponsor Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Haemodynamic Instability during Spine Surgery To calculate Incidence of Haemodynamic Instability during Spine Surgery allover one year
Primary Risk factors of Haemodynamic Instability during Spine Surgery To analyze risk factors of Haemodynamic Instability during Spine Surgery allover one year
Primary outcomes of Haemodynamic Instability during Spine Surgery To calculate the rate of mortality of Haemodynamic Instability during Spine Surgery allover one year
Primary Incidence of cardiac arrest during Spine Surgery To calculate Incidence of cardiac arrest during Spine Surgery allover one year
Primary Risk factors of cardiac arrest during Spine Surgery To analyze risk factors of cardiac arrest during Spine Surgery allover one year
Primary outcomes of Cardiac Arrest during Spine Surgery To calculate the rate of mortality of cardiac arrest during Spine Surgery allover one year
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