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

NCT05164146 | Completed

• 1 other identifier: 4-2021-1456
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients Undergoing Neurosurgery

Outcome Measures

Primary Outcomes (1)

• incidence of hypotension events

  Hypotension is considered when the mean blood pressure is 20% or more below the baseline mean blood pressure.

  procedure (during induction before the surgery)

Secondary Outcomes (3)

• blood pressure

  procedure (during induction before the surgery)

• heart rate

  procedure (during induction before the surgery)

• sedline psi

  procedure (during induction before the surgery)

Study Arms (2)

propofol group

ACTIVE COMPARATOR

During the induction, propofol was controlled according to sedline (Psi target 40)

Drug: propofol

remimazolam group

EXPERIMENTAL

During induction, remimazolam dose was controlled according to sedline (Psi target 40)

Drug: remimazolam

Interventions

propofol DRUG

during the induction, remimazolam dose was controlled according to sedline (Psi target 40)

propofol group

remimazolam DRUG

During induction, remimazolam dose was controlled according to sedline (Psi target 40)

remimazolam group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hypertension
• patients undergoing neurosurgery
• ASA I-III
• year-old patients

You may not qualify if:

• emergency
• Patients admitted on the day of surgery
• cardiac disease
• liver failure or liver cirrhosis
• increased intracranial pressure(IICP)
• mental change
• Foreigner
• iliteracy

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

Related Publications (1)

• Choi SH, Min KT, Park EK, Park S. Comparison of hypotension incidence between remimazolam and propofol in patients with hypertension undergoing neurosurgery: prospective, randomized, single-blind trial. BMC Anesthesiol. 2024 Jun 4;24(1):198. doi: 10.1186/s12871-024-02578-7.

  PMID: 38834996 DERIVED

MeSH Terms

Interventions

Propofol; remimazolam

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Sujung Park

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: December 20, 2021
• Study Start: February 23, 2022
• Primary Completion: August 10, 2022
• Study Completion: August 10, 2022
• Last Updated: November 7, 2022

Record last verified: 2022-11

Locations

KR (1)