Dexmedetomidine as an adjuvant to levobupivacaine for spinal anaesthesia in elderly patients undergoing hip replacement surgery: Prospective, randomised, double-blinded study.

Phase 2

• Conditions: hip replacement surgery; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12623000153617
• Lead Sponsor: niversity Hospital Centre Sestre Milosrdnice

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-16
• Last Update Posted: 27 February 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients undergoing hip replacement surgery.
2. Patients 70 years old or older
3. ASA II, III

Exclusion Criteria

1. Patients height less than 150 cm.
2. Aortic valve stenosis gr 3+
3. Allergies
4. Coagulopathy
5. Patient refusal
6. Elevated ICP
7. Puncture point infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of analgesia. Assessed by anaesthetist review as a measure of time elapsed until first intravenous analgetic is applied.[Timepoints are 2, 4, 6, 8, 10 and 12 (primary endpoint) hours after performing spinal block.];The onset of sensory block will be determined as the timepoint where the patient reports they are unable to feel the sensation of ice touching their skin at the level of the T10 dermatome,<br><br>[Timepoints are 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 (primary endpoint) minutes after performing spinal block.];The duration of sensory block assessed by anaesthetist review. It will be determined as the timepoint where the patient reports they are able to again feel cold sensation on their skin at the level of TH10 dermatome.[Timepoints are 2, 4, 6, 8, 10 and 12 (primary endpoint) hours after performing spinal block.]

Secondary Outcome Measures

Name	Time	Method
Vomiting assessed by patient complaint- data collected from medical records.[Continuously monitored from start of spinal block to 2 hours after surgery completion.];Duration of motoric blockade assessed by anaesthetist review. Time elapsed until complete recovery of motoric function (Bromage scale 4)[Timepoints are 2, 4, 6, 8, 10 and 12 hours after performing spinal block.];Bradycardia measured by pulse oximeter.[Continuously monitored from start of spinal block to 2 hours after surgery completion.];Hypotension measured by sphygmomanometer[Continuously monitored from start of spinal block to 2 hours after surgery completion.];Nausea assessed by patient complaint- data collected from medical records.[Continuously monitored from start of spinal block to 2 hours after surgery completion.];Shivering assessed by patient complaint- data collected from medical records.[Continuously monitored from start of spinal block to 2 hours after surgery completion.]