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Clinical Trials/NCT05183061
NCT05183061CompletedNot Applicable

Factors Associated With Post-induction Hypotension in Idiopathic Normal Pressure Hydrocephalus (iNPH) Patient Undergoing Ventriculoperitoneal (VP) and Lumbar Peritoneal (LP) Shunt

Mahidol University1 site in 1 country426 target enrollmentStarted: June 1, 2021Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
426
Locations
1
Primary Endpoint
Factors associated with post-induction hypotension in iNPH patients undergoing VP or LP shunt procedures
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study is a retrospective work involving the review of patients who were scheduled for VP or LP shunt in Siriraj Hospital, Mahidol University, Thailand. The sample size calculation was based on the rule of thumbs of the logistic regression comprising 18 risk factors. The incidence of post-induction hypotension according to our institution's pilot study November 2019-January 2020) was 47%. With 10% addition for missing data and other possible reasons, the sample size was 426. The primary objective of the study is to report the factors associated with post-induction hypotension in iNPH patients undergoing VP or LP shunt procedures. Our secondary objective is to determine the incidence of post-induction hypotension in these patients.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Elective cases of iNPH scheduled for VP and LP shunt
  • •Patients aged > 18 years old

Exclusion Criteria

  • •Emergency cases

Arms & Interventions

Hypotensive group

Hypotenson is defined as systolic blood pressure (SBP) < 80 mmHg or a drop more than 20% from baseline SBP for longer than 10 minutes or a drop that requires treatment either vasopressor or inotropic drugs.

Intervention: Ehedrine Norepineprine (Drug)

Outcomes

Primary Outcomes

Factors associated with post-induction hypotension in iNPH patients undergoing VP or LP shunt procedures

Time Frame: 9 months

Risk factors associated with post-induction hypotension after administration of anesthetic agents

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Phuriphong Songarj

Associate Professor

Mahidol University

Study Sites (1)

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