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.
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
- Recruiting
Cairo university hospitals
Cairo, Giza Governorate
Mai Younes, MD, 01002309065, younesmai555@gmail.com
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.
- Conditions
- IV Ketamine With Spinal Block
- 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 group | Role | What they receive |
|---|---|---|
| ketamine group | Active comparator | 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. 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 group | Placebo comparator | Patients 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.
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)
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
Duration of motor block (defined as time per minutes to reach a modified Bromage score of 0)
Measured: 1st 24 hours after spinal block
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.
- First posted9 Apr 2026
- Study start25 Apr 2026
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IV Ketamine With Spinal BlockStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai younes Taha, Cairo University
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07520487
- Acronym / sponsor ID
- IV Ketamine with spinal block
- Conditions
- IV Ketamine With Spinal Block
- Keywords
- ketamine, spinal block, dermatome, aging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Apr 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effect of Intravenous Ketamine combined with Spinal Anesthesia on Sensory Block
Duration compared to Spinal Anesthesia alone in Lower Limb surgeries in geriatrics:
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketamine group | Active comparator | 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 solutionPatients 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 group | Placebo comparator | Drug: Patients will receive 5 ml of saline followed by infusion 0.1 ml/kg/hr as a 20 ml solution as a control groupPatients will receive 5 ml of saline followed by infusion 0.1 ml/kg/hr as a 20 ml solution as a control group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients aged 65 years and older
Key exclusion criteria (5 listed)
- Patient's refusal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 solutionPatients 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 | Drug | ketamine group |
| Patients will receive 5 ml of saline followed by infusion 0.1 ml/kg/hr as a 20 ml solution as a control groupPatients will receive 5 ml of saline followed by infusion 0.1 ml/kg/hr as a 20 ml solution as a control group | Drug | saline group |
Primary outcome
Duration of 2-segment regression time.
Time frame: post delivery of spinal block during intraoperative 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.
3 secondary outcomes
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.
Time frame: Intraoprtative period after delivery of spinal block
Duration of motor block (defined as time per minutes to reach a modified Bromage score of 0)
Time frame: 1st 24 hours after spinal block
Duration of spinal analgesia (time per minutes to the first request for the rescue analgesia)
Time frame: 1st 24 hours post spinal block
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.