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Not yet recruiting NCT07616882

Comparison of Hemodynamic Effects of Bupivacaine in Spinal Anesthesia

Phase II Interventional Hemondynamic Changes in Spinal Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spinal Anesthesia (bupivacaine), Spinal Anesthesia (bupivacaine).
Who it may be relevant to
Registry conditions: Hemondynamic Changes in Spinal Anesthesia. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of Hemodynamic Effects of Fractionated Dose Versus Bolus Dose of Hyperbaric Bupivacaine (0.5%) in Spinal Anesthesia for Lower Limb Surgery

Overview

To assess hemodynamic changes with hyperbaric bupivacaine with spinal anesthesia

Detailed description

Assesment of hemodynamic changes like heart rate and blood pressure with hyperbaric bupivacaine in spinal anesthesia when given in fractionanted versus bolus dose manner

Interventions

  • Drug Spinal Anesthesia (bupivacaine)
    In this group B spinal Anesthesia will be given in one single shot
  • Drug Spinal Anesthesia (bupivacaine)
    In this intervention spinal Anesthesia of bupivacaine will be given in a fractionated manner that is 2/3 of dose initially and then 1/3 after 90 seconds

Primary outcome measures

  • Mean Arterial Pressure [Time frame: Baseline and up to 120 minutes]
Secondary outcome measures (2)
  • Hypotension and bradycardia [Time frame: Baseline and up to 120 minutes]
  • Requirement of vasopressors [Time frame: Baseline and up to 120 minutes]

Eligibility criteria

Inclusion criteria

  • ASA I and II
  • Adults 18 to 60 years of age of either gender
  • height from 160 to 182cm and BMI from 15 to 29.9kg/m2

Exclusion criteria

  • ASA III and IV
  • Refusal of consent
  • any known renal, hepatic, cardiac or cerebrovascular disease
  • hypersensitivity to local anaesthetics drug
  • spinal deformity or any contra indications to spinal anesthesia

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Prevention

Study locations

Pakistan · 1 center
  • Liaquat National Hospital — Karachi

Identifiers

NCT: NCT07616882 · 1369-2026-LNH-ERC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗