Procedural sedation in patients undergoing elective lower limb surgery under spinal anaesthesia Surgery
Conditions
Interventions
Participants were randomised in a 1:1 ratio, stratified by age younger than 70 years versus 70 years or older, using random permuted blocks of variable size prepared in advance by an investigator not
Sponsors
Cappagh National Orthopaedic Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years or older 2. Scheduled for elective lower-limb orthopaedic surgery under spinal anaesthesia as the primary anaesthetic technique 3. American Society of Anesthesiologists (ASA) physical status I–III 4. Able to provide written informed consent 5. Able to complete study questionnaires in the validated study language
Exclusion criteria
Exclusion criteria: 1. Cases with planned general anaesthesia in combination with spinal anaesthesia from the outset 2. Known contraindication or documented hypersensitivity to benzodiazepines 3. Known history of severe paradoxical reaction to benzodiazepines 4. Severe cognitive, linguistic, or sensory communication barriers preventing valid questionnaire completion 5. Clinical situations where the attending anaesthetist determines that sedation is mandatory for patient safety prior to randomisation 6. Participation in another interventional clinical trial that may affect the outcomes of this study. Exclusion criteria are intentionally limited to preserve the pragmatic nature of the trial and to ensure that the pilot population is representative of the population that will be enrolled in the definitive trial.
Countries
Ireland
Contacts
Public ContactAlyssa Kaplan
Outcome results
None listed