Factors Associated With Post-induction Hypotension in iNPH Patient Undergoing VP and LP Shunt

Completed

• Conditions: The iNPH Patients Scheduled for VP or LP Shunt Procedures
• Interventions: Drug: Ehedrine Norepineprine

• Registration Number: NCT05183061
• Lead Sponsor: Mahidol University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2021-11-30
• Status Verified: 2021-12
• Study Completion: 2021-12-20
• Study First Submitted: 2021-12-21
• Study First Submitted QC: 2021-12-21
• Last Update Submitted: 2021-12-21
• Study First Posted: 2022-01-10
• Last Update Posted: 2022-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 426

Inclusion Criteria

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

Exclusion Criteria

• Emergency cases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypotensive group	Ehedrine Norepineprine	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.

Primary Outcome Measures

Name	Time	Method
Factors associated with post-induction hypotension in iNPH patients undergoing VP or LP shunt procedures	9 months	Risk factors associated with post-induction hypotension after administration of anesthetic agents

Trial Locations

Locations (1)

Anesthesiology Department; 🇹🇭 Bangkok, Thailand