The Comparison of Hypotension Incidence Between Remimazolam and Propofol in Hypertensive Patients Undergoing Neurosurgery

Not Applicable

Completed

• Conditions: Patients Undergoing Neurosurgery
• Interventions: Drug: propofol; Drug: remimazolam

• Registration Number: NCT05164146
• Lead Sponsor: Yonsei University

Brief Summary

This study aims to find an excellent drug in terms of hemodynamic stability when comparing the propofol and remifentanil with the combined use of remimazolam and remifentanil. When the mean blood pressure falls by 20% or more from the baseline mean blood pressure, it is considered hypotension, and a vasopressor such as ephedrine, phenylephrine, or norpin is used to control the blood pressure to within 20% of the baseline blood pressure. If the blood pressure increases by 20% or more above the baseline mean blood pressure, nicardipine infusion or remimazolam, propofol or remifentanil should be increased to control the blood pressure.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-15
• Study First Submitted QC: 2021-12-17
• Study First Posted: 2021-12-20
• Study Start: 2022-02-23
• Primary Completion: 2022-08-10
• Study Completion: 2022-08-10
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. hypertension
2. patients undergoing neurosurgery
3. ASA I-III
4. 19-75 year-old patients

Exclusion Criteria

1. emergency
2. Patients admitted on the day of surgery
3. cardiac disease
4. liver failure or liver cirrhosis
5. increased intracranial pressure(IICP)
6. mental change
7. Foreigner
8. iliteracy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol group	propofol	During the induction, propofol was controlled according to sedline (Psi target 40)
remimazolam group	remimazolam	During induction, remimazolam dose was controlled according to sedline (Psi target 40)

Primary Outcome Measures

Name	Time	Method
incidence of hypotension events	procedure (during induction before the surgery)	Hypotension is considered when the mean blood pressure is 20% or more below the baseline mean blood pressure.

Secondary Outcome Measures

Name	Time	Method
blood pressure	procedure (during induction before the surgery)	Blood pressure will be recorded from the start of drugs infusion to 10 minutes after intubation every 1 minutes, and they will be compared between two groups.
heart rate	procedure (during induction before the surgery)	heart rate will be recorded from the start of drugs infusion to 10 minutes after intubation every 1 minutes, and they will be compared between two groups.
sedline psi	procedure (during induction before the surgery)	sedline psi will be recorded from the start of drugs infusion to 10 minutes after intubation every 1 minutes, and they will be compared between two groups.

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of