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Active, not recruitingNCT06767397Updated Jan 9, 2025

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

An observational study in Pelvic Floor Disorders, sponsored by Superior University. Active, not recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-09.

Sponsored by Superior University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
172
Ages
18 Years to 85 Years
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Pelvic Floor Disorders
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In context

Pelvic Floor Disorders

203 studies on the registry are indexed under Pelvic Floor Disorders; 46 are open to participants now.

This study's enrollment of 172 is above the median of 145 across 60 observational studies indexed under Pelvic Floor Disorders.

Browse Pelvic Floor Disorders studies →

Lead sponsor

Superior University is the lead sponsor of 253 studies on the registry; 25 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
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.

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

  • 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

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
172 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testgeneral anesthesia

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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 Months

  2. 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)

    Time frame: 12 Months

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Study locations

1 site
  • Mardan Medical Complex
    Mardan, Khyber Pakhtunkhwa, Pakistan
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06767397
Responsible party
Muhammad Naveed Babur (Principal Investigator, Superior University) — Principal investigator
First posted
Jan 9, 2025
Start date
Feb 28, 2024
Primary completion
Aug 1, 2024
Completion
Mar 1, 2025 (estimated)
Last update
Jan 9, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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