Intralipid InfusionNCT07025343
Does Intralipid Infusion Can Reverse the Spinal Anesthesia Effect in Day Case Surgery?
A study testing Lipid emulsion in people with Intralipid Infusion and Spinal Anesthesia, run by Benha University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effect of intralipid infusion on reversing the spinal anesthesia effect in day case surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intralipid Infusion, Spinal Anesthesia, Day Case Surgery
- What is being tested?
- Lipid emulsion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Scheduled for day-case surgery under spinal anesthesia.
- Time of surgery less than 90 min.
Who cannot join
- Patients with contraindications for outpatient surgery or spinal anesthesia.
- Local anaesthetic (LA) allergy.
- Those receiving anticoagulant therapy.
- Emergency cases.
- Pregnant cases.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the effect of intralipid infusion on reversing the spinal anesthesia effect in day case surgery.
Read the detailed description
The increasing demand for day-case surgery has led to a growing interest in developing strategies to provide patients with a more convenient, cost-effective, and less invasive alternative to traditional inpatient procedures.
Spinal anesthesia, in particular, is a widely used technique in day-case surgery due to its ability to provide excellent analgesia with minimal side effects.
Intravenous lipid emulsion therapy is commonly used to treat local anesthetic systemic toxicity (LAST) and has demonstrated some efficacy in treating other drug toxicities, particularly cardiotoxicity from lipophilic drugs.
- Conditions
- Intralipid Infusion, Spinal Anesthesia, Day Case Surgery
- Being tested
- Lipid emulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid emulsionOther
Patients (>70kg will receive 100 ml, <70 will receive 1.5ml/kg) of 20% intravenous lipid emulsion at the end of surgery as a study group.
| Study group | Role | What they receive |
|---|---|---|
| Group S | Experimental | Patients (>70kg will receive 100 ml, <70 will receive 1.5ml/kg) of 20% intravenous lipid emulsion at the end of surgery as a study group. Receives: Other: Lipid emulsion |
| Group C | No intervention | Patients will not receive intravenous lipid emulsion as a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset time of the motor block
The onset time of the motor block using the modified Bromage scale will be assessed. The motor block will be measured when the maximum dermatomal spread is achieved using the modified Bromage scale (0: no motor block, 1: hip blocked, 2: hip and knee blocked, and 3: hip, knee, and ankle blocked).
Measured: Intraoperatively
Secondary outcomes (7)
Duration of motor block
The motor block will be measured when the maximum dermatomal spread is achieved using the modified Bromage scale (0: no motor block, 1: hip blocked, 2: hip and knee blocked, and 3: hip, knee, and ankle blocked).
Measured: Intraoperatively
Time till home readiness
The time to home readiness will be assessed as the time from the end of surgery until the patients reached a post-anesthesia discharge score (PADS) ≥9 and are able to void spontaneously.
Measured: 24 hours postoperatively
Time to the 1st rescue analgesia
Time to the first request for the rescue analgesia (time from end of surgery to first dose of tramadol administrated).
Measured: 24 hours postoperatively
Total tramadol consumption
Rescue analgesia of 100mg IV tramadol will be given if the numerical rating scale (NRS)> 3 to be repeated after 30 min if pain persists (with maximum dose 400mg) until the NRS < 4.
Measured: 24 hours postoperatively
Degree of pain
Each patient will be instructed about postoperative pain assessment with the numerical rating scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").
Measured: 24 hours postoperatively
Incidence of adverse events
Incidence of adverse events such as bradycardia, urinary retention, leg paralysis, or any other complication will be recorded.
Measured: 24 hours postoperatively
Time from the end of surgery till movement
Time from the end of surgery till movement will be recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Feb 2025
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intralipid InfusionStudies of the same condition, open and under way.
- More trials run by Benha 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Sharara, MD, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025343
- Sponsor's protocol ID
- RC 6-1-2025
- Status last verified
- Dec 2025
- First submitted
- 10 Jun 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Intralipid Infusion Can Reverse the Spinal Anesthesia Effect in Day Case Surgery?
- ClinicalTrials.gov ID
- NCT07025343
- Acronym / sponsor ID
- RC 6-1-2025
- Conditions
- Intralipid Infusion, Spinal Anesthesia, Day Case Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 17 Jun 2025 (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.
This study aims to evaluate the effect of intralipid infusion on reversing the spinal anesthesia effect in day case surgery.
Detailed description
The increasing demand for day-case surgery has led to a growing interest in developing strategies to provide patients with a more convenient, cost-effective, and less invasive alternative to traditional inpatient procedures.
Spinal anesthesia, in particular, is a widely used technique in day-case surgery due to its ability to provide excellent analgesia with minimal side effects.
Intravenous lipid emulsion therapy is commonly used to treat local anesthetic systemic toxicity (LAST) and has demonstrated some efficacy in treating other drug toxicities, particularly cardiotoxicity from lipophilic drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S | Experimental | Other: Lipid emulsionPatients (>70kg will receive 100 ml, <70 will receive 1.5ml/kg) of 20% intravenous lipid emulsion at the end of surgery as a study group. |
| Group C | No intervention | –Patients will not receive intravenous lipid emulsion as a control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age from 18 to 65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Scheduled for day-case surgery under spinal anesthesia.
- Time of surgery less than 90 min.
Key exclusion criteria (5 listed)
- Patients with contraindications for outpatient surgery or spinal anesthesia.
- Local anaesthetic (LA) allergy.
- Those receiving anticoagulant therapy.
- Emergency cases.
- Pregnant cases.
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 |
|---|---|---|
| Lipid emulsionPatients (>70kg will receive 100 ml, <70 will receive 1.5ml/kg) of 20% intravenous lipid emulsion at the end of surgery as a study group. | Other | Group S |
Primary outcome
Onset time of the motor block
Time frame: Intraoperatively
The onset time of the motor block using the modified Bromage scale will be assessed. The motor block will be measured when the maximum dermatomal spread is achieved using the modified Bromage scale (0: no motor block, 1: hip blocked, 2: hip and knee blocked, and 3: hip, knee, and ankle blocked).
7 secondary outcomes
Duration of motor block
Time frame: Intraoperatively
Time till home readiness
Time frame: 24 hours postoperatively
Time to the 1st rescue analgesia
Time frame: 24 hours postoperatively
Total tramadol consumption
Time frame: 24 hours postoperatively
Degree of pain
Time frame: 24 hours postoperatively
Incidence of adverse events
Time frame: 24 hours postoperatively
Time from the end of surgery till movement
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipid emulsion in people with Intralipid Infusion and Spinal Anesthesia, run by Benha 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 5 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: finished, as of the sponsor's last update on 8 Dec 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset time of the motor block (time frame: Intraoperatively). 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 8 Dec 2025.