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IV Ketamine With Spinal BlockNCT07520487

Effect of Intravenous Ketamine Combined With Spinal Anesthesia on Sensory Block Duration Compared to Spinal Anesthesia Alone in Lower Limb Surgeries in Geriatrics.

A study testing Patients will receive 0.2 mg/kg IV of ketamine diluted to 5 ml followed by infusion 0.1 mg/kg/hr as a 20 ml solution in people with IV Ketamine With Spinal Block, run by Cairo University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Effect of Intravenous Ketamine combined with Spinal Anesthesia on Sensory Block Duration compared to Spinal Anesthesia alone in Lower Limb surgeries in geriatrics: Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
IV Ketamine With Spinal Block
What is being tested?
Patients will receive 0.2 mg/kg IV of ketamine diluted to 5 ml followed by infusion 0.1 mg/kg/hr as a 20 ml solution
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
61 participants
Where
1 siteEgypt
Study dates
25 Apr 2026to Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site, 1 recruiting
  • Cairo university hospitals

    Cairo, Giza Governorate

    Mai Younes, MD, 01002309065, younesmai555@gmail.com

    Recruiting

Other trials in Egypt

About this study

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.

Effect of Intravenous Ketamine combined with Spinal Anesthesia on Sensory Block

Duration compared to Spinal Anesthesia alone in Lower Limb surgeries in geriatrics:

Read the detailed description

Spinal anesthesia is a potent anesthetic procedure and is widely used as it has a number of advantages compared to general anesthesia especially in the geriatric population. It is used for both emergency and elective surgeries and involves the injection of a local anesthetic agent into the cerebrospinal fluid, thereby blocking nerve transmission . Regional anesthesia has been suggested as an alternative to general anesthesia in order to evade or decrease general anesthetic exposure . Neuraxial anesthesia offers numerous benefits as it minimizes the surgical stress, reduces the pulmonary compromise (atelectasis, prolonged mechanical ventilation), provides a superior postoperative pain control and reduction of perioperative opioids consumption, hence minimizing opioid side effects. Neuraxial anesthesia results in better peripheral vascular circulation and reduces total blood loss. Finding adjuvants for spinal anesthesia in geriatric patients is crucial because it allows for the use of lower doses of local anesthetics, which helps minimize potential side effects like hypotension and respiratory depression, while still providing effective pain relief during and after surgery. Adjuvants can also improve the quality and duration of the block, leading to better patient outcomes and faster recovery. Hyperbaric bupivacaine 0.5% is widely used in spinal anesthesia. Main disadvantage of spinal anesthesia with bupivacaine 0.5% is it won't prolong duration of post-operative analgesia . Therefore, research for a drug that may decrease the severity of post-operative pain with minimal side effects seems mandatory. A number of adjuvants have been used to improve post-operative analgesia, along with the bupivacaine. These are opioids, epinephrine, clonidine, dexmedetomidine, midazolam, neostigmine and ketamine . While no study to date has directly assessed the effect of intravenous ketamine infusion on two-segment sensory regression time under spinal anesthesia in elderly patients, related literature provides strong indirect support. For instance, Kathirvel et al. (2000) compared intravenous ketamine versus dexmedetomidine as adjuvants to bupivacaine for spinal anesthesia and reported on onset and duration of sensory and motor block, though not specifically two-segment regression Moreover, a recent 2024 meta-analysis found that ketamine added to regional anesthetic techniques significantly prolongs sensory block by an average of 29.1 minutes. While these studies do not exactly mirror our protocol, they support the hypothesis that IV ketamine may enhance block duration. This underscores the novelty and importance of the current trial, which directly evaluates two-segment regression in a geriatric population undergoing lower-limb surgery.

Ketamine, an N-methyl-D-aspartate (NMDA) receptor blocker, has an anesthetic effect and is synergic with bupivacaine . Its beneficial effects on the cardiovascular system and respiratory functions may be combined with the analgesic effects of spinal anesthesia. Ketamine's impact on cognitive function is largely attributed to its noncompetitive antagonism of NMDA receptors, which disrupts excitatory glutamatergic neurotransmission. Additionally, ketamine increases dopamine release in the prefrontal cortex, which contributes to its psychotomimetic effects such as hallucinations or perceptual disturbances. On the other hand, subanesthetic doses of ketamine have been shown to exert anti-inflammatory and neuroprotective properties, particularly by inhibiting microglial activation and reducing pro inflammatory cytokines implicated in postoperative cognitive dysfunction (POCD). These dual and dose-dependent mechanisms highlight why ketamine may induce cognitive disturbances in some elderly patients while potentially protecting against neuroinflammation-induced cognitive decline in others.

Being tested
Patients will receive 0.2 mg/kg IV of ketamine diluted to 5 ml followed by infusion 0.1 mg/kg/hr as a 20 ml solution, Patients will receive 5 ml of saline followed by infusion 0.1 ml/kg/hr as a 20 ml solution as a control group
Keywords
ketamine, spinal block, dermatome, aging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patients will receive 0.2 mg/kg IV of ketamine diluted to 5 ml followed by infusion 0.1 mg/kg/hr as a 20 ml solutionDrug

    Patients will receive 0.2 mg/kg IV of ketamine diluted to 5 ml followed by infusion 0.1 mg/kg/hr as a 20 ml solution

  • Patients will receive 5 ml of saline followed by infusion 0.1 ml/kg/hr as a 20 ml solution as a control groupDrug

    Patients will receive 5 ml of saline followed by infusion 0.1 ml/kg/hr as a 20 ml solution as a control group

Study groups in NCT07520487
Study groupRoleWhat they receive
ketamine groupActive comparatorPatients will receive 0.2 mg/kg IV of ketamine diluted to 5 ml followed by infusion 0.1 mg/kg/hr as a 20 ml solution.
Receives: Drug: Patients will receive 0.2 mg/kg IV of ketamine diluted to 5 ml followed by infusion 0.1 mg/kg/hr as a 20 ml solution
saline groupPlacebo comparatorPatients will receive 5 ml of saline followed by infusion 0.1 ml/kg/hr as a 20 ml solution as a control group
Receives: Drug: Patients will receive 5 ml of saline followed by infusion 0.1 ml/kg/hr as a 20 ml solution as a control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of 2-segment regression time.

    Duration of 2-segment regression time (defined as time per minutes needed for recovery of sensory block by two segments from the highest sensory level achieved in that patient) using pinprick method.

    Measured: post delivery of spinal block during intraoperative time

Secondary outcomes (3)
  1. Total Duration of sensory block (defined as time per minutes beginning from the intrathecal injection of the drug, to recovery of patient's sensation at S2 dermatome bilaterally) using pinprick method.

    Measured: Intraoprtative period after delivery of spinal block

  2. Duration of motor block (defined as time per minutes to reach a modified Bromage score of 0)

    Measured: 1st 24 hours after spinal block

  3. Duration of spinal analgesia (time per minutes to the first request for the rescue analgesia)

    Measured: 1st 24 hours post spinal block

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2026
  2. Study start25 Apr 2026
  3. Primary completionAug 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
61 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07520487
Sponsor's protocol ID
IV Ketamine with spinal block
Status last verified
Apr 2026
First submitted
3 Apr 2026
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Patients will receive 0.2 mg/kg IV of ketamine diluted to 5 ml followed by infusion 0.1 mg/kg/hr as a 20 ml solution in people with IV Ketamine With Spinal Block, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of 2-segment regression time. (time frame: post delivery of spinal block during intraoperative time). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

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