ClinicalTrials.gg
Status unknownNCT05131854Updated Mar 10, 2022

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

An observational study in Spine Surgery, sponsored by Zagazig University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-10.

Sponsored by Zagazig University · Observational

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Spine Surgery

Keywords

  • spine surgery , bradycardia , cardiac arrest
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In context

Bradycardia

313 studies on the registry are indexed under Bradycardia; 70 are open to participants now.

This study's planned enrollment of 100 is below the median of 250 across 131 observational studies indexed under Bradycardia.

Browse Bradycardia studies →

Lead sponsor

Zagazig University is the lead sponsor of 457 studies on the registry; 77 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

population candidated for spine surgery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Incidence of Haemodynamic Instability during Spine Surgery

    To calculate Incidence of Haemodynamic Instability during Spine Surgery

    Time frame: allover one year

  2. Risk factors of Haemodynamic Instability during Spine Surgery

    To analyze risk factors of Haemodynamic Instability during Spine Surgery

    Time frame: allover one year

  3. outcomes of Haemodynamic Instability during Spine Surgery

    To calculate the rate of mortality of Haemodynamic Instability during Spine Surgery

    Time frame: allover one year

  4. Incidence of cardiac arrest during Spine Surgery

    To calculate Incidence of cardiac arrest during Spine Surgery

    Time frame: allover one year

  5. Risk factors of cardiac arrest during Spine Surgery

    To analyze risk factors of cardiac arrest during Spine Surgery

    Time frame: allover one year

  6. outcomes of Cardiac Arrest during Spine Surgery

    To calculate the rate of mortality of cardiac arrest during Spine Surgery

    Time frame: allover one year

07

Study locations

1 of 1 sites recruiting
  • Zagazig university
    Zagazig, Egypt
    • zagazig university · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05131854
Lead sponsor
Zagazig University
Responsible party
Essamedin Mamdouh Negm (principal investigator, Zagazig University) — Principal investigator
First posted
Nov 23, 2021
Start date
Nov 25, 2021
Primary completion
Oct 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Mar 10, 2022

Study contacts

Essamedin Negm, MD
Contact
alpherdawss@gmail.com
0021098123058
Essam youssef
Contact
0021002815325

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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