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NCT04082676

Height Versus Height and Weight Based Spinal Bupivacaine on Maternal Haemodynamics for Elective Cesarean in Short Stature Patients

Completed Phase 4 Last updated 22 March 2022
What this trial tests

Phase 4 trial testing Hyperbaric bupivacaine spinal in Maternal Hypotension After Spinal Anesthesia in 112 participants. Completed in 1 September 2021.

Timeline
30 November 2019
Primary endpoint
1 September 2021
1 September 2021

Quick facts

Lead sponsorB.P. Koirala Institute of Health Sciences
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment112
Start date30 November 2019
Primary completion1 September 2021
Estimated completion1 September 2021
Sites1 location across Nepal

Drugs / interventions tested

Conditions studied

Sponsor

B.P. Koirala Institute of Health Sciences

Who can join

Adults 18 to 40, female only, with Maternal Hypotension After Spinal Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Doses of intrathecal bupivacaine based on patients either height or height and weight has shown to lower the risk of maternal hypotension with similar quality of anesthesia compared to conventional doses. In clinical practice there is a tendency of reducing the dose of bupivacaine as either low fixed dose or using the doses based on either height and weight or height (0.06mg/cm) alone in parturient with short stature. However, there is lack of evidence regarding the appropriate dose required in this group of patients. Therefore, our aim is to compare the height versus height and weight based intrathecal bupivacaine dose for elective caesarean on maternal haemodynamics in short stature patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Effect of height versus height/weight-based spinal bupivacaine on maternal hemodynamics for elective cesarean in short stature patients: a randomized clinical trial.
    Subedi A, Thapa P, Prajapati R, Schyns-van den Berg AMJV. · · 2023 · cited 2× · PMID 37709952 · DOI 10.1007/s00540-023-03252-x

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