Adding low-dose IV ketamine to spinal anesthesia to prolong numbness for lower-limb surgery in older adults
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.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 61 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo, Giza Governorate) |
| Trial ID | NCT07520487 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cairo, Giza Governorate
- Cairo university hospitals — Cairo, Giza Governorate, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.