Effects of Remimazolam on the Intraoperative Hemodynamics in Bypass Surgery

Intraoperative Hypotension Clinical Trial

Official title:

Effects of Remimazolam on the Intraoperative Hemodynamic Parameters in Patients Undergoing Extracranial-intracranial Bypass Surgery: a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05557253
• Other study ID #: Bypass-RMDZ
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: October 2022
• Source: Seoul National University Hospital
• Contact: Chang-Hoon Koo
• Phone: +821085098841
• Email: vollock9[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized, controlled trial. A total of 72 patients will be randomized to receive remimazolam anesthesia or balanced anesthesia (propofol + desflurane) during extracranial-intracranial bypass surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patients who undergo elective extracranial-intracranial bypass surgery

• American Society of Anesthesiologists grade 1,2,3

• Age > 18 years old

Exclusion Criteria:

• Refuse to participate to the study

• American Society of Anesthesiologists grade 4

• Body Mass Index < 18.5 kg/m2 or > 35 kg/m2

• Allergic history of benzodiazepine

• Pregnant

• Acute narrow-angle glaucoma

• Shock or Coma

• Acute alcohol addicted

• Obstructive sleep apnea

• dependency on alcohol or drug

• Severe acute respiratory insufficiency

• Hypersensitivity to Dextran 40

Related Conditions & MeSH terms

• Hypotension
• Intraoperative Hypotension

Intervention

Drug:
• Remimazolam
Anesthesia induction: remimazolam 6-12 mg/kg/h Anesthesia maintenance: remimazolam 1-2 mg/kg/h
• Balanced Anesthesia
Anesthesia induction: propofol 1.5-2 mg/kg Anesthesia maintenance: Desflurane 6-8 vol%

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative hypotension	Target Systolic Blood Pressure < 80%	During surgery
Secondary	Inotropic requirements	Dose of inotropics administered during surgery	During surgery
Secondary	Incidence of bradycardia	heart rate < 40 /min	During surgery
Secondary	Incidence of tachycardia	heart rate > 100 /min	During surgery
Secondary	Maximum systolic blood pressure	Maximal systolic blood pressure during surgery (mmHg)	During surgery
Secondary	Minimum systolic blood pressure	Minimal systolic blood pressure during surgery (mmHg)	During surgery
Secondary	Brain relaxation score	1=perfectly relaxed, 2=satisfactorily relaxed, 3=firm brain, 4=bulging brain	Immediately after dura opening