Effect of Preoperative Ultrasound-Guided Stellate Ganglion Block on Postoperative Delirium in Older Adults Undergoing Elective Peripheral Endovascular Intervention

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorAssiut University

About this trial

This randomized controlled trial will evaluate whether preoperative ultrasound-guided stellate ganglion block reduces the incidence of postoperative delirium in adults aged 60 years or older undergoing elective peripheral endovascular interventions. Participants will be randomly allocated in a 1:1 ratio to receive either a right-sided ultrasound-guided stellate ganglion block at the C6 level with 5 mL of 0.375% ropivacaine or a control group. Postoperative delirium will be assessed twice daily during the first 3 postoperative days using the 3-Minute Diagnostic Interview for Confusion Assessment Method-defined Delirium (3D-CAM).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥65 years.

Scheduled for elective peripheral endovascular interventions.

American Society of Anesthesiologists (ASA) physical status I-III.

Ability to provide written informed consent or consent through a legal representative

Disqualifiers

Preexisting cognitive impairment (Montreal Cognitive Assessment score below the education-adjusted cutoff) or diagnosed dementia.

Severe visual or hearing impairment or language barrier precluding reliable delirium assessment.

Major psychiatric disorders, including schizophrenia or bipolar disorder.

Contraindications to stellate ganglion block, including local infection at the puncture site, known allergy to local anesthetics, or severe coagulopathy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ropivacaine

    Drug

    5 mL of 0.375% ropivacaine administered during ultrasound-guided right stellate ganglion block at the C6 level approximately 30 minutes before surgery.

Treatment groups

168 Participants
are divided into 2 treatment groups
Group A: Ultrasound-Guided Stellate Ganglion BlockExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Cumulative incidence of postoperative delirium

.Postoperative delirium will be assessed twice daily during the first 3 postoperative days using the 3-Minute Diagnostic Interview for Confusion Assessment Method-defined Delirium (3D-CAM). A participant will be considered to have developed postoperative delirium if at least one postoperative delirium assessment is positive during the first 3 postoperative days.

Time frame
postoperative 24 hours , 48 hours , 72 hours.

Secondary outcomes

1

Delirium severity

the severity of delirium will be graded using Memorial Delirium Assessment Scale (MDAS)

Time frame
postoperative 24 hours , 48 hours , 72 hours , among participants diagnosed with postoperative delirium
2

Duration of postoperative delirium

Number of postoperative days with a positive 3D-CAM assessment

Time frame
postoperative 24 hours , 48 hours , 72 hours.
3

Postoperative pain intensity

Postoperative pain intensity will be assessed by Numerical Rating Scale (NRS)

Time frame
Immediate postoperative period 2 hours 6 hours 12 hours 24 hours
4

Total postoperative opioid consumption

by Morphine milligram equivalents (MME)

Time frame
postoperative 24 hours , 48 hours , 72 hours.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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