Postoperative Delirium (POD)NCT07848113
Effect of Preoperative Ultrasound-Guided Stellate Ganglion Block on Postoperative Delirium in Older Adults Undergoing Elective Peripheral Endovascular Intervention
A study testing ropivacaine in people with Postoperative Delirium (POD) and Peripheral Arterial Disease, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium (POD), Peripheral Arterial Disease
- What is being tested?
- ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 May 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- Severe systemic disease, including Child-Pugh C liver cirrhosis, end-stage renal disease (eGFR <30 mL/min/1.73 m² or dialysis), or NYHA class III-IV heart failure.
- Emergency surgery.
- History of substance abuse
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Preoperative Ultrasound-Guided Stellate Ganglion Block on Postoperative Delirium in Older Adults Undergoing Elective Peripheral Endovascular Interventions: A Randomized Controlled 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).
Read the detailed description
Postoperative delirium is a frequent complication among older adults undergoing surgery and vascular interventions. This study will investigate whether preoperative ultrasound-guided stellate ganglion block can reduce postoperative delirium through modulation of sympathetic activity and potentially inflammatory responses.
Eligible participants aged 60 years or older undergoing elective peripheral endovascular interventions will be randomly allocated in a 1:1 ratio to an active stellate ganglion block group or control group. The active intervention will consist of a right-sided ultrasound-guided stellate ganglion block performed at the C6 level approximately 30 minutes before surgery, using a 22-gauge needle and 5 mL of 0.375% ropivacaine. The control group will receive standard perioperative care and regional anesthesia according to the study protocol, but no stellate ganglion block or sham procedure will be performed
All participants will receive standardized anesthesia consisting of ultrasound-guided combined femoral and sciatic nerve blocks with bupivacaine, supplemented by dexmedetomidine sedation.
The primary outcome will be cumulative incidence of postoperative delirium from postoperative day 1 through postoperative day 3, assessed twice daily using the 3D-CAM. Secondary outcomes will include delirium severity, delirium duration, postoperative pain, opioid consumption, and safety/adverse events.
- Being tested
- ropivacaine
- Keywords
- Postoperative delirium, stellate ganglion block
- Medical subject headings
- Emergence Delirium, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaineDrug
5 mL of 0.375% ropivacaine administered during ultrasound-guided right stellate ganglion block at the C6 level approximately 30 minutes before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided Stellate Ganglion Block | Experimental | Participants will receive a right-sided ultrasound-guided stellate ganglion block at the C6 level approximately 30 minutes before surgery. Under sterile conditions and real-time ultrasound guidance, a 22-gauge needle will be advanced to the prevertebral fascia. After negative aspiration, 5 mL of 0.375% ropivacaine will be injected. Successful sympathetic blockade will be assessed by development of Horner's syndrome and/or a relative increase in ipsilateral skin temperature of ≥1.5°C within 15 minutes after injection Receives: Drug: ropivacaine |
| control group | No intervention | the participants will receive standard perioperative care and regional anesthesia according to the study protocol, but no stellate ganglion block or sham procedure will be performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: postoperative 24 hours , 48 hours , 72 hours.
Secondary outcomes (5)
Delirium severity
the severity of delirium will be graded using Memorial Delirium Assessment Scale (MDAS)
Measured: postoperative 24 hours , 48 hours , 72 hours , among participants diagnosed with postoperative delirium
Duration of postoperative delirium
Number of postoperative days with a positive 3D-CAM assessment
Measured: postoperative 24 hours , 48 hours , 72 hours.
Postoperative pain intensity
Postoperative pain intensity will be assessed by Numerical Rating Scale (NRS)
Measured: Immediate postoperative period 2 hours 6 hours 12 hours 24 hours
Total postoperative opioid consumption
by Morphine milligram equivalents (MME)
Measured: postoperative 24 hours , 48 hours , 72 hours.
Safety and adverse events
Measured: postoperative 24 hours , 48 hours , 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Postoperative Delirium (POD)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Loay Gamal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848113
- Sponsor's protocol ID
- Postoperative Delirium
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gao WB, Wang WH, Zhou ST, Lu ZW, Xiang X, Hu J, Jin TY, Ni CB, Yao M, Ni HD. Efficacy of Repetitive Transcranial Magnetic Stimulation on Postoperative Delirium in Elderly Patients Undergoing Non-Cardiac Major Surgery: A Randomized Controlled Trial. Brain Behav. 2026 Feb;16(2):e71242. doi: 10.1002/brb3.71242.
PubMed 41612909Yoo Y, Lee CS, Kim YC, Moon JY, Finlayson RJ. A Randomized Comparison between 4, 6 and 8 mL of Local Anesthetic for Ultrasound-Guided Stellate Ganglion Block. J Clin Med. 2019 Aug 27;8(9):1314. doi: 10.3390/jcm8091314.
PubMed 31461935Stevens RA, Stotz A, Kao TC, Powar M, Burgess S, Kleinman B. The relative increase in skin temperature after stellate ganglion block is predictive of a complete sympathectomy of the hand. Reg Anesth Pain Med. 1998 May-Jun;23(3):266-70. doi: 10.1016/s1098-7339(98)90053-0.
PubMed 9613538Maldonado JR. Neuropathogenesis of delirium: review of current etiologic theories and common pathways. Am J Geriatr Psychiatry. 2013 Dec;21(12):1190-222. doi: 10.1016/j.jagp.2013.09.005.
PubMed 24206937Cerejeira J, Firmino H, Vaz-Serra A, Mukaetova-Ladinska EB. The neuroinflammatory hypothesis of delirium. Acta Neuropathol. 2010 Jun;119(6):737-54. doi: 10.1007/s00401-010-0674-1. Epub 2010 Mar 24.
PubMed 20309566Deiner S, Silverstein JH. Postoperative delirium and cognitive dysfunction. Br J Anaesth. 2009 Dec;103 Suppl 1(Suppl 1):i41-46. doi: 10.1093/bja/aep291.
PubMed 20007989Marcantonio ER. Delirium in Hospitalized Older Adults. N Engl J Med. 2017 Oct 12;377(15):1456-1466. doi: 10.1056/NEJMcp1605501.
PubMed 29020579Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
PubMed 23992774