Comparison in Frequency of Hypotension Between Remimazolam and Propofol in Hip Surgery

Anesthesia, Spinal Clinical Trial

Official title:

Comparison in Frequency of Hypotension During Sedation of Propofol and Remimazolam in Spinal Anesthesia in Hip Surgery Patients: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05651399
• Other study ID #: 2021-1713
• Status: Recruiting
• Phase: Phase 4
• Start date: December 26, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Asan Medical Center
• Contact: Hyeokseong Park
• Phone: 01051401323
• Email: phsung509[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the incidence of hypotension between remimazolam and propofol for intraoperative sedation in patients undergoing hip surgery with spinal anesthesia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

Inclusion Criteria:

• ASA physical status 1-3

• Patients scheduled for hip joint surgery under spinal anesthesia and sedation with propofol or remimzolam

Exclusion Criteria:

• Patients who refuse to participate in this study

• Patients with uncontrolled high blood pressure, hyperthyroidism, dementia in the inability to communicate, or symptomatic coronary artery disease

• Patients with an allergy to propofol, fentanyl, or bupivacaine

• Patients contraindicated for spinal anesthesia, such as coagulopathy, severe aortic stenosis/mitral stenosis, and active infection on lumbar region

• Patients judged to be inappropriate for this study

Related Conditions & MeSH terms

• Anesthesia, Spinal
• Hypotension
• Orthopedic Procedures
• Propofol
• Remimazolam
• Sedatives

Intervention

Drug:
• Remimazolam
Patients receive remimazolam at a rate of 1 mg/kg/hr. When a patient's MOAA/S reaches 3 or less, the rate of remomazolam is maintained at a rate between 0.3 mg/kr/hr and 1.0 mg/kg/hr until the end of surgery.
• Propofol
Patients are administered propofol with an effect-site concentration of 1.0 mcg/mL to 2.5 mcg/mL by target controlled infusion.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of hypotension during surgery (1hour)	mean blood pressure less than 65mmHg	up to 1 hour after initiation of drug infusion
Secondary	Frequency of hypotension during surgery	mean blood pressure less than 65mmHg	Throughout the surgery
Secondary	Total administered phenylephrine	total dose of phenylephrine administered during surgery	Throughout the surgery
Secondary	Fluid volume	Total amount of fluid infused during surgery	Throughout the surgery
Secondary	Number of hypotensive episodes in the post-anesthesia care unit after surgery	mean blood pressure less than 65mmHg	up to 1 hour after postanesthesia care unit entry
Secondary	Complications after surgery	Cardiovascular/neurological/respiratory complications, delirium, impaired renal function, or postoperative nausea and vomiting	up to 7 days after surgery