Incidence , Risk Factors and Outcomes of Haemodynamic Instability and Cardiac Arrest During Spine Surgery

Spine Surgery Clinical Trial

Official title:

Incidence , Risk Factors and Outcomes of Haemodynamic Instability and Cardiac Arrest During Spine Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05131854
• Other study ID #: 8078-13-10-2021
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Heart Arrest
• Spine Surgery

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