Comparison of two methods of administering a short-acting sedative drug during hip and knee replacement surgery under spinal anesthesia

A randomized controlled trial comparing intermittent bolus administration versus target-controlled infusion of remimazolam for moderate sedation in adult patients undergoing hip or knee arthroplasty under spinal anesthesia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11676212

Enrollment

Registered

2026-03-19

Start date

2023-09-01

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Sedation management in adult patients undergoing hip or knee arthroplasty under spinal anesthesia Surgery

Interventions

Participants are randomly assigned in a 1:1:1 ratio using computer-generated block randomisation to one of three intervention arms: intermittent bolus administration of remimazolam, target-controlled

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 18 years or older 2. Scheduled for elective hip or knee arthroplasty 3. Planned to undergo surgery under spinal anesthesia 4. American Society of Anesthesiologists physical status class I–III 5. Able to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Hepatic impairment (alanine aminotransferase or aspartate aminotransferase >100 IU L?¹ or aspartate aminotransferase to alanine aminotransferase ratio =2:1) 2. Known hypersensitivity or allergy to benzodiazepines 3. Chronic or daily use of benzodiazepines 4. Cognitive impairment precluding reliable assessment of sedation level or informed consent 5. Contraindications to spinal anesthesia 6. Contraindications to procedural sedation

Countries

Latvia

Contacts

Public ContactRihards Serzans

rihards.serzans+research@rsu.lv+371 (0)67061579

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 4, 2026