Comparison of Hemodynamic Effects of Bupivacaine in Spinal Anesthesia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorLiaquat National Hospital & Medical College
About this trial
To assess hemodynamic changes with hyperbaric bupivacaine with spinal anesthesia
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
ASA III and IV
Refusal of consent
any known renal, hepatic, cardiac or cerebrovascular disease
hypersensitivity to local anaesthetics drug
Trial design
Design model
Crossover
Treatments tested in this trial
Spinal Anesthesia (bupivacaine)
DrugIn this group B spinal Anesthesia will be given in one single shot
Spinal Anesthesia (bupivacaine)
DrugIn 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
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Group B (Bolus)Active comparator 1 intervention
Group B: Group F (Fractionated)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean Arterial Pressure
Difference in mean arterial pressure between Group B and Group F
Time frame
Baseline and up to 120 minutesSecondary outcomes
1
Hypotension and bradycardia
Incidence of hypotension and bradycardia after spinal Anesthesia between Group B and Group F
Time frame
Baseline and up to 120 minutes2
Requirement of vasopressors
Requirements of vasopressors if mean arterial pressure falls below 60mmHg during the procedure and up to 120 minutes
Time frame
Baseline and up to 120 minutesSponsors and contacts
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Source ClinicalTrials.gov
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