Preventing low blood pressure after spinal anesthesia with a small dose of ketamine in orthopedic surgery
Official title: Impact of Sub-anesthetic Dose of Ketamine in the Prevention of Post Spinal Hypotension in Patients Undergoing Orthopedic Surgeries
Run by Ain Shams University · NCT06995690 · Data updated 2026-11-12
This trial will test if a single sub‑anesthetic IV dose of ketamine given before spinal anesthesia can prevent low blood pressure in adults having elective orthopedic surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | October 1, 2025 |
| Study ends | November 1, 2025 |
| Registry record updated | June 18, 2025 |
| Trial ID | NCT06995690 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with ASA physical status I–II who are scheduled for elective orthopedic surgery under spinal anesthesia, have BMI <35 kg/m2, and expect operations of 1–3 hours are ideal candidates.
✕Probably not a fit
Patients with cardiovascular or pulmonary disease, preexisting hypotension, or those not receiving spinal anesthesia are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double‑blind, placebo‑controlled trial comparing 0.5 mg/kg IV ketamine to volume‑matched normal saline given over 20 minutes before spinal anesthesia for elective orthopedic procedures. All participants receive standard spinal anesthesia with 0.5% heavy bupivacaine plus fentanyl, and the primary outcome is incidence of hypotension defined as a mean arterial pressure drop >20% from baseline. Secondary outcomes include bradycardia, nausea, vomiting, hallucinations, and total vasopressor dose. Participants are ASA I–II adults with BMI <35 kg/m2 and operations lasting 1–3 hours.
Why it matters
Potential benefit: If successful, this approach could reduce the frequency of post‑spinal hypotension and lower the need for rescue vasopressors, improving safety during spinal anesthesia.
How similar studies have gone: Prior small trials and physiologic studies have suggested low‑dose ketamine can support blood pressure during neuraxial anesthesia, but results have been limited and somewhat mixed.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients American Society of Anesthesiologists Physical Status (ASA) I to II undergoing orthopedic surgeries under spinal anesthesia. * Both Sexes. * Patients aged equal to or above 18 years. * Body mass index \<35 kg/m2 * Duration of operation from 1 hour to 3 hours Exclusion Criteria: * Patients' refusal of procedure or participation in the study. * Patients with contraindication to spinal anesthesia. * Patients with cardiovascular or pulmonary disease. * Patients with pre-procedural hypotension (systolic arterial pressure less than 90 mmHg and/or mean arterial pressure less than 60 mmHg). * Patients aged below 18 years. * Duration of operation below 1 hour or above 3 hours.
Where it's running
-
Ain Shams University Hospitals
Cairo, Egypt Recruiting
Study contacts
- Principal investigator: Reem H El Kabarity, M.D — Faculty of Medicine, Ain Shams University
- Study coordinator: Amira G Abdelmoniem Abdalla, M.B.B.Ch.
- Email: am.ga.ab.ab.mo@gmail.com
- Phone: +201277719693
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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.