ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

hip replacement surgery

Condition category

Condition code

Musculoskeletal

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]

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]

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]

Timepoints are 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 (primary endpoint) minutes after performing spinal block.

Primary outcome [2]

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]

Timepoints are 2, 4, 6, 8, 10 and 12 (primary endpoint) hours after performing spinal block.

Primary outcome [3]

Duration of analgesia. Assessed by anaesthetist review as a measure of time elapsed until first intravenous analgetic is applied.

Timepoint [3]

Timepoints are 2, 4, 6, 8, 10 and 12 (primary endpoint) hours after performing spinal block.

Secondary outcome [1]

Bradycardia measured by pulse oximeter.

Timepoint [1]