Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000153617
Ethics application status
Approved
Date submitted
29/07/2022
Date registered
16/02/2023
Date last updated
16/02/2023
Date data sharing statement initially provided
16/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Dexmedetomidine as an adjuvant to levobupivacaine for spinal anaesthesia in elderly patients undergoing hip replacement surgery: Prospective, randomised, double-blinded study.
Scientific title
Efficacy of dexmedetomidine as an adjuvant to levobupivacaine for spinal anaesthesia in elderly patients undergoing hip replacement surgery: Prospective, randomised, double-blinded study.
Secondary ID [1] 307629 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hip replacement surgery 327118 0
Condition category
Condition code
Musculoskeletal 324260 324260 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Spinal anesthesia will be performed on thirty ASA Grade II and III
geriatric patients undergoing hip surgery. Before the procedure all patients will receive 500mL of intravenous saline. Noninvasive blood pressure, heart rate and SpO2 were noted every 5 minutes. Patients will be randomly assigned into two groups. Subject group(n=30) will receive once only spinal anesthesia with levobupivacaine by body height nomogram and 5 mcg of dexmedetomidine intrathecally(Doses and effects of levobupivacaine and bupivacaine for spinal anaesthesia M. del-Rio-Vellosillo, J.J. Garcia-Medina, M.D. Pinazo-Duran, A. Abengochea-Cotaina; British Journal of Anaesthesia Volume 113, Issue 3, September 2014, Pages 521-522). Administration will occur 30 minutes prior to the first incision. Dexmedetomidine will be administered intrathecally concurrently with levobupivacaine. Groups will be compared by hemodynamic parameters, use of vasopressors, duration of motoric and sensoric block, duration and quality of postoperative analgesia and side effects: bradycardia, hypotension, respiratory depression.
Intervention code [1] 324079 0
Treatment: Drugs
Comparator / control treatment
Control group (n=30) will once only receive intrathecally levobupivacaine by body height nomogram with 2.5 mcg (0.5 mL) of sufentanil, Sufentanil will be administered concurrently with levobupivacaine intrathecally 30 minutes prior to the first incision.
Control group
Active

Outcomes
Primary outcome [1] 332071 0
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,
Timepoint [1] 332071 0
Timepoints are 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 (primary endpoint) minutes after performing spinal block.
Primary outcome [2] 332072 0
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.
Timepoint [2] 332072 0
Timepoints are 2, 4, 6, 8, 10 and 12 (primary endpoint) hours after performing spinal block.
Primary outcome [3] 332073 0
Duration of analgesia. Assessed by anaesthetist review as a measure of time elapsed until first intravenous analgetic is applied.
Timepoint [3] 332073 0
Timepoints are 2, 4, 6, 8, 10 and 12 (primary endpoint) hours after performing spinal block.
Secondary outcome [1] 412092 0
Bradycardia measured by pulse oximeter.
Timepoint [1] 412092 0
Continuously monitored from start of spinal block to 2 hours after surgery completion.
Secondary outcome [2] 412093 0
Hypotension measured by sphygmomanometer
Timepoint [2] 412093 0
Continuously monitored from start of spinal block to 2 hours after surgery completion.
Secondary outcome [3] 412094 0
Nausea assessed by patient complaint- data collected from medical records.
Timepoint [3] 412094 0
Continuously monitored from start of spinal block to 2 hours after surgery completion.
Secondary outcome [4] 412095 0
Shivering assessed by patient complaint- data collected from medical records.
Timepoint [4] 412095 0
Continuously monitored from start of spinal block to 2 hours after surgery completion.
Secondary outcome [5] 412096 0
Vomiting assessed by patient complaint- data collected from medical records.
Timepoint [5] 412096 0
Continuously monitored from start of spinal block to 2 hours after surgery completion.
Secondary outcome [6] 412097 0
Duration of motoric blockade assessed by anaesthetist review. Time elapsed until complete recovery of motoric function (Bromage scale 4)
Timepoint [6] 412097 0
Timepoints are 2, 4, 6, 8, 10 and 12 hours after performing spinal block.

Eligibility
Key inclusion criteria
1. Patients undergoing hip replacement surgery.
2. Patients 70 years old or older
3. ASA II, III
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
Date of last participant enrolment
Anticipated
31/05/2023
Actual
Date of last data collection
Anticipated
1/06/2023
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 24926 0
Croatia
State/province [1] 24926 0
City of Zagreb

Funding & Sponsors
Funding source category [1] 311893 0
Hospital
Name [1] 311893 0
University Hospital Centre Sestre Milosrdnice
Country [1] 311893 0
Croatia
Primary sponsor type
Hospital
Name
University Hospital Centre Sestre Milosrdnice
Address
City of Zagreb
10000
Vinogradska cesta 29
Country
Croatia
Secondary sponsor category [1] 313373 0
None
Name [1] 313373 0
none
Address [1] 313373 0
none
Country [1] 313373 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311328 0
University hospital centre Sestre Milosrdnice Ethical Committee
Ethics committee address [1] 311328 0
Vinogradska cesta 29
City of Zagreb
10000
Ethics committee country [1] 311328 0
Croatia
Date submitted for ethics approval [1] 311328 0
28/12/2021
Approval date [1] 311328 0
13/01/2022
Ethics approval number [1] 311328 0
003 -06122-03 I 00 1

Summary
Brief summary
Spinal anesthesia is a preferred method of anesthesia for lower limb
surgery. Antinociceptive synergism between local anesthetics and opioids is well studied.
Together they provide superior and effective anesthesia, prolong the duration and effectiveness of postoperative analgesia without prolonging motoric block but with possible side effects (hemodynamic instability, respiratory depression). Dexmedetomidine, selective alpha2-agonist, is well examined as an adjuvant to peripheral nerve blocks, but relatively new as a intrathecal agent. The main goal of this study is to compare opioids with dexmedetomidine as adjuvant to spinal anesthesia, especially their effect on hemodynamic stability in elderly patients. Hypothesis of this study is that dexmedetomidine offers equal quality of spinal anesthesia with lower incidence of side effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120730 0
Dr Bruna Bodulica
Address 120730 0
University Hospital Centre Sestre milosrdnice, Vinogradska 29
City of Zagreb
10000
Country 120730 0
Croatia
Phone 120730 0
+385958505835
Fax 120730 0
Email 120730 0
brunabod@gmail.com
Contact person for public queries
Name 120731 0
Dr Bruna Bodulica
Address 120731 0
University Hospital Centre Sestre milosrdnice, Vinogradska 29
City of Zagreb
10000
Country 120731 0
Croatia
Phone 120731 0
+385958505835
Fax 120731 0
Email 120731 0
brunabod@gmail.com
Contact person for scientific queries
Name 120732 0
Dr Bruna Bodulica
Address 120732 0
University Hospital Centre Sestre milosrdnice, Vinogradska 29
City of Zagreb
10000
Country 120732 0
Croatia
Phone 120732 0
+385958505835
Fax 120732 0
Email 120732 0
brunabod@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.