Adding low-dose IV ketamine to spinal anesthesia to prolong numbness for lower-limb surgery in older adults
Official title: Effect of Intravenous Ketamine Combined With Spinal Anesthesia on Sensory Block Duration Compared to Spinal Anesthesia Alone in Lower Limb Surgeries in Geriatrics: A Randomized Controlled Double-Blinded Trial.
Run by Cairo University · NCT07520487 · Data updated 2026-11-12
This test will see if giving a small IV ketamine bolus and infusion with spinal anesthesia prolongs the sensory block in people aged 65 and older having elective lower‑limb surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 61 (estimated) |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo, Giza Governorate) |
| Status | Recruiting |
| Started | April 25, 2026 |
| Main results expected | August 2026 |
| Study ends | August 2026 |
| Registry record updated | April 30, 2026 |
| Trial ID | NCT07520487 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 65 years or older of either sex with ASA physical status I–III scheduled for elective lower‑limb surgery in the supine position under spinal anesthesia are ideal candidates.
✕Probably not a fit
Patients with coagulopathy, preexisting neurological disorders, local infection at the puncture site, known hypersensitivity to the drugs used, or who are unwilling to participate are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Older adults scheduled for elective lower‑limb surgery under spinal anesthesia will receive standard spinal anesthesia with hyperbaric bupivacaine 0.5% and be assigned to either an IV ketamine arm (0.2 mg/kg bolus diluted to 5 ml followed by 0.1 mg/kg/hr infusion) or a placebo saline arm (5 ml bolus followed by matching infusion). The primary outcome is duration of sensory block measured by dermatome level over time after spinal injection. Secondary observations include postoperative analgesia requirements and hemodynamic/neurologic safety in the geriatric population. The protocol excludes patients with coagulopathy, preexisting neurologic disorders, local infection at the needle site, known drug allergies, or those who refuse participation.
Why it matters
Potential benefit: If successful, adding low‑dose IV ketamine could prolong postoperative sensory block, reduce opioid needs, and improve pain control after lower‑limb surgery in older adults.
How similar studies have gone: Some prior perioperative ketamine studies have shown reduced opioid use and prolonged analgesia, but IV ketamine specifically combined with spinal bupivacaine in geriatric lower‑limb surgery is relatively under‑studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 65 years and older * Both sexes * American Society of Anesthesiologists (ASA) physical status I, II, III * Scheduled for elective lower limb surgeries under spinal anesthesia in supine position Exclusion Criteria: * Patient's refusal. * Pre-existing neurological disorders. * Coagulopathy (i.e., Platelets ≤ 60,000 and/or INR\> 1.5). * Localized infection at the site of needle insertion. * Known hypersensitivity or allergies to any of the used drugs
Where it's running
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Cairo university hospitals
Cairo, Giza Governorate, Egypt Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.