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NCT04401345

Effect of Glycopyrrolate on Vasopressors Requirement for Non-elective Caesarean Section Under Spinal Anaesthesia

Completed Phase 4 Last updated 21 February 2021
What this trial tests

Phase 4 trial testing Glycopyrrolate 0.2 MG/ML in Glycopyrrolate in 258 participants. Completed in 31 January 2021.

Timeline
1 June 2020
Primary endpoint
31 January 2021
31 January 2021

Quick facts

Lead sponsorRajesh Deshar
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment258
Start date1 June 2020
Primary completion31 January 2021
Estimated completion31 January 2021
Sites1 location across Nepal

Drugs / interventions tested

Conditions studied

Sponsor

Rajesh Deshar — full company profile →

Who can join

Adults 18 to 40, female only, with Glycopyrrolate or Post-spinal Hypotension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is prospective randomised double blind study conducted in parturients planned for non-elective caesarean section under spinal anaesthesia. Glycopyrrolate group will receive 0.2 mg of Glycopyrrolate before start of phenylephrine infusion. Control group will receive 0.2 ml of Normal Saline before start of phenylephrine infusion. Total amount of vasopressors required i.e. ephedrine or phenylephrine will recorded in the form of phenylephrine equivalent during intraoperative period.

Publications & conference data

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

  1. Effect of glycopyrrolate on vasopressor requirements for non-elective cesarean section under spinal anesthesia: a randomized, double-blind, placebo-controlled trial.
    Deshar R, Subedi A, Pokharel K, Sah BP, et al · · 2022 · cited 5× · PMID 36284288 · DOI 10.1186/s12871-022-01882-4

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