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NCT Number: NCT07616882

Comparison of Hemodynamic Effects of Bupivacaine in Spinal Anesthesia

To assess hemodynamic changes with hyperbaric bupivacaine with spinal anesthesia

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Liaquat National Hospital

Karachi, Sindh, 74000, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Spinal Anesthesia (bupivacaine)

Drug

In this group B spinal Anesthesia will be given in one single shot

Primary outcomes

  1. Mean Arterial Pressure

    Time frame: Baseline and up to 120 minutes

    Difference in mean arterial pressure between Group B and Group F

Secondary outcomes

  1. Hypotension and bradycardia

    Time frame: Baseline and up to 120 minutes

    Incidence of hypotension and bradycardia after spinal Anesthesia between Group B and Group F

  2. Requirement of vasopressors

    Time frame: Baseline and up to 120 minutes

    Requirements of vasopressors if mean arterial pressure falls below 60mmHg during the procedure and up to 120 minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Usama, MBBS

CONTACT

[email protected]

+923008978791

Sponsors and collaborators

Lead sponsor

Liaquat National Hospital & Medical College

Other

Registry information

Official study title

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

Acronym: Nill

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

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.