Comparison in frequency of hypotension during sedation of propofol and remimazolam in spinal anesthesia in hip surgery patients: a randomized controlled clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0006873

Enrollment

Registered

2021-12-27

Start date

2022-02-01

Completion date

Unknown

Last updated

2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : When the patient arrives in the operating room, standard monitoring is performed. Spinal anesthesia is performed while supplying oxygen to all patients via a facial mask. Heavy marcaine 10mg an

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * ASA physical status 1-3 * Age: Adults from 20 to 64 years of age * Patients scheduled for hip surgery under spinal anesthesia and sedation using propofol or remimzolam

Exclusion criteria

Exclusion criteria: * Denial of consent * Uncontrolled hypertension, hyperthyroidism, incommunicable dementia, symptomatic coronary artery disease * Those who are allergic to propofol, fentanyl, or bupivacaine * Contraindications to spinal anesthesia such as coagulopathy, severe aortic stenosis/mitral stenosis, active infection on lumbar region

Design outcomes

Primary

Measure	Time frame
The purpose of this study was to investigate whether there was a difference in the incidence of hypotension during surgery between the two groups. (MBP<65)	—

Secondary

Measure	Time frame
The incidence of intraoperative hypertension (SBP>160) ;Total dose of phenylephrine administered during surgery ;Total amount of fluid infused during surgery ;Number of episodes of hypotension in the PACU( post anesthesia care unit) after surgery (MBP<65) ;postoperative complications ( cardiovascular, neurologica, respiratory, delirium, renal function, postoperative nausea and vomiting, etc) ;Time to recovery after surgery (time until modified observer's alertness/sedation scale (MOAA/S) score of 5 or higher after stopping drug injection)	—

Measure

Time frame

The incidence of intraoperative hypertension (SBP>160) ;Total dose of phenylephrine administered during surgery ;Total amount of fluid infused during surgery ;Number of episodes of hypotension in the PACU( post anesthesia care unit) after surgery (MBP<65) ;postoperative complications ( cardiovascular, neurologica, respiratory, delirium, renal function, postoperative nausea and vomiting, etc) ;Time to recovery after surgery (time until modified observer's alertness/sedation scale (MOAA/S) score of 5 or higher after stopping drug injection)

—

Countries

Korea, Republic of

Contacts

Public ContactYeon Ju Kim

Asan Medical Center

clever8808@naver.com+82-2-3010-1785

Outcome results