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

Sponsor

Asan Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05651399

Collaborator

(none)

Enrollment

Location

Arms

12.5

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Remimazolam Propofol Orthopedic Procedures Sedatives Anesthesia, Spinal	Drug: Remimazolam Drug: Propofol	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Dec 15, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Remimazolam A maintenance dose of remimazolam is administered for sedation	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.
Active Comparator: Propofol A maintenance dose of propofol is administered for sedation	Drug: Propofol Patients are administered propofol with an effect-site concentration of 1.0 mcg/mL to 2.5 mcg/mL by target controlled infusion.

Arm

Intervention/Treatment

Active Comparator: Remimazolam

A maintenance dose of remimazolam is administered for sedation

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.

Active Comparator: Propofol

A maintenance dose of propofol is administered for sedation

Drug: Propofol

Patients are administered propofol with an effect-site concentration of 1.0 mcg/mL to 2.5 mcg/mL by target controlled infusion.

Outcome Measures

Primary Outcome Measures

Frequency of hypotension during surgery (1hour) [up to 1 hour after initiation of drug infusion]
mean blood pressure less than 65mmHg

Secondary Outcome Measures

Frequency of hypotension during surgery [Throughout the surgery]
mean blood pressure less than 65mmHg
Total administered phenylephrine [Throughout the surgery]
total dose of phenylephrine administered during surgery
Fluid volume [Throughout the surgery]
Total amount of fluid infused during surgery
Number of hypotensive episodes in the post-anesthesia care unit after surgery [up to 1 hour after postanesthesia care unit entry]
mean blood pressure less than 65mmHg
Complications after surgery [up to 7 days after surgery]
Cardiovascular/neurological/respiratory complications, delirium, impaired renal function, or postoperative nausea and vomiting

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of	05505

Sponsors and Collaborators

Asan Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hajung Kim, Clinical assistant professor, Asan Medical Center

ClinicalTrials.gov Identifier:

NCT05651399

Other Study ID Numbers:

2021-1713

First Posted:

Dec 15, 2022

Last Update Posted:

Dec 15, 2022

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypotension

Propofol

Study Results

No Results Posted as of Dec 15, 2022