Factors Influencing Hemodynamic Stability and Its Management in Patients Undergoing Pelvic Surgery Under Spinal and GA

Patients are at risk for hemodynamic instability both during and after surgery, as it is an independent predictor of long-term patient morbidity and length of hospital stay. The development of hemodynamic instability is caused by a number of factors. When these risk factors are prevented or treated, patients may experience less hemodynamic instability during pelvic surgery, as well as the morbidity and mortality that come with it in both spinal and general anesthesia.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pelvic Floor Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mardan Medical Complex

Mardan, Khyber Pakhtunkhwa, Pakistan

About this study

The objective of this study was to evaluate the factors that affect the hemodynamic stability and evaluate the effectiveness of different management strategies employed to maintain hemodynamic stability during spinal and general anesthesia.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients aged 18 years and older.
ASA (American Society of Anesthesiologists) physical status classification I and II.
Patients scheduled for elective pelvic surgery.
Can give informed consent or has a legal representative to give consent.
There are no contraindications to spinal or general anesthesia based on preoperative assessment (e.g, severe cardiovascular disease, no previous history of adverse anesthetic reactions).

Exclusion criteria

Age below 18 years.
Emergency procedures or that require immediate intervention.
Pregnancy or breastfeeding status.
Conditions such as spinal cord disease and severe coagulopathy that are recognized contraindications to spinal or general anesthesia.
ASA physical status classification III and above.
History of severe adverse reactions to anesthesia or known allergy to anesthetic agents.
Concurrent involvement in additional clinical trials that could have an impact on the treatment of anesthesia or hemodynamic results.
Individuals with substantial comorbidities (such as uncontrolled hypertension or heart failure) that might complicate hemodynamic responses.

Treatment and study plan

general anesthesia

Diagnostic Test

To evaluate the factors that affect the hemodynamic stability in patients undergoing spinal anesthesia and general anesthesia during pelvic surgery.

Primary outcomes

Hemodynamic instability

Time frame: 12 Months

Hemodynamic instability determined by criteria such as fluctuations of ± 20% in the systolic or diastolic blood pressure from the baseline and measured in millimetre of mercury), fluctuations in heart rate (e.g., pulse rate ± 10% of baseline), and the lack of clinically significant hypotension or episodes of bradycardia.Oxygen saturation measured by pulse oximeter and < 90% of SPO2 was considered desaturated.
Self-designed questionnaire

Time frame: 12 Months

Self-designed questionnaire for the evaluation of the factors like Age in years, weight in kilograms, Physical health status by (ASA) American Society of Anesthesiologists classification where ASA I was physically fit patients having only surgical pathology and ASA II patient with mild systemic disease. scoring from (1-100)

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

Factors Influencing the Hemodynamic Stability and Its Management in Patients Undergoing Pelvic Surgery Under Spinal and General Anesthesia

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Jan 9, 2025
Registry last updated: Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting