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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pelvic Floor Disorders
• Intervention / Treatment: Diagnostic test: general anesthesia

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 172

Contacts and Locations

Study Locations

• Pakistan
  • Khyber Pakhtunkhwa
    • Mardan, Khyber Pakhtunkhwa, Pakistan
      • Mardan Medical Complex

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Intraoperatively hemodunamic instability during spinal and general anesthesia was adressed and also evaluate its management.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic instability	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.	12 Months
Self-designed questionnaire	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)	12 Months

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2024
• Primary Completion (Actual): August 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: January 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 5, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Pelvic Floor Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: MSAHS/Batch-Spring23/035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No