LidocaineNCT05690087
Lidocaine Infusion on Optic Nerve Sheath Diameter in Laparoscopic Hysterectomy in Trendelenburg Position
A study testing Lidocaine and sodium chloride 0.9% solution in people with Lidocaine and Optic Nerve Sheath Diameter, run by Tanta University at 1 site in Egypt.
Trial summary
We hypothesize that intravenous lidocaine infusion may have beneficial effect to patients undergoing laparoscopic surgeries in Trendelenburg position by preventing ICP elevation. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women only
- Conditions the study is for
- Lidocaine, Optic Nerve Sheath Diameter, Laparoscopic Hysterectomy
- What is being tested?
- Lidocaine and sodium chloride 0.9% solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 1 Jan 2024
- 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 35 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 35 to 65 years
- American society of anesthesiology (ASA) physical status I - II
- Body mass index (BMI) between 18.5 to 28.0 kg/m2
- Scheduled for total laparoscopic hysterectomy taking approximately 2 h with a 30° Trendelenburg position for management of uterine fibroids or refractory dysfunctional uterine bleeding.
Who cannot join
- Patients with eye diseases, central nervous system diseases, cardiovascular diseases, cerebrovascular diseases or diabetes.
- If these events occurred intraoperative:
- Ultrasound scans or measurements failed to clearly show the structure of Optic Nerve Sheath Diameter (ONSD).
- Surgical time less than 1 h.
- Interruption of carbon dioxide (CO2) pneumoperitoneum and Trendelenburg position.
- Peak airway pressure exceeding 35 cm H2O
- Patients with a history of allergy to lidocaine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Systemic Lidocaine Infusion on Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Hysterectomy in Trendelenburg Position
We hypothesize that intravenous lidocaine infusion may have beneficial effect to patients undergoing laparoscopic surgeries in Trendelenburg position by preventing ICP elevation.
Read the detailed description
Lidocaine use, both intravenous (IV) and laryngotracheal (LT), has been reported to blunt the ICP elevations during intubation. Also, Lidocaine injected IV has been shown in models to induce cerebral vasoconstriction leading to a decrease in cerebral blood volume and thus ICP. Furthermore, IV lidocaine leads to sodium channel inhibition and thus a reduction in cerebral activity and metabolic demands, as well as excitotoxicity, leading to a potential ICP reduction effect.
- Being tested
- Lidocaine, sodium chloride 0.9% solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
intravenous lidocaine 2% bolus of 1.5 mg/kg over 5 min before induction of anesthesia followed by lidocaine infusion at 1.5 mg/kg/h intraoperatively until desufflation
sodium chloride 0.9% solutionDrug
intravenous sodium chloride 0.9% solution volume matched bolus and infusion.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine group | Experimental | Intravenous lidocaine 2% bolus of 1.5 mg/kg over 5 min before induction of anesthesia followed by lidocaine infusion at 1.5 mg/kg/h intraoperatively until desufflation. Receives: Drug: Lidocaine |
| Control group | Placebo comparator | Intravenous sodium chloride 0.9% solution volume matched in bolus and infusion. Receives: Drug: sodium chloride 0.9% solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic Nerve Sheath Diameter (ONSD)
ONSD at 5 min before induction of anesthesia in supine position (T1), 5 min after CO2 pneumoperitoneum in Trendelenburg position (T2), 30 min after CO2 pneumoperitoneum in Trendelenburg position (T3), 60 min after CO2 pneumoperitoneum in Trendelenburg position (T4) and 5 min after the closure of pneumoperitoneum in supine position (T5).
Measured: 5 min before induction of anesthesia till 5 min after the closure of pneumoperitoneum
Secondary outcomes (3)
Heart rate
Heart rate at 5 min before induction of anesthesia in supine position (T1), 5 min after CO2 pneumoperitoneum in Trendelenburg position (T2), 30 min after CO2 pneumoperitoneum in Trendelenburg position (T3), 60 min after CO2 pneumoperitoneum in Trendelenburg position (T4) and 5 min after the closure of pneumoperitoneum in supine position (T5).
Measured: 5 min before induction of anesthesia till 5 min after the closure of pneumoperitoneum
Mean arterial blood pressure
Mean arterial blood pressure at 5 min before induction of anesthesia in supine position (T1), 5 min after CO2 pneumoperitoneum in Trendelenburg position (T2), 30 min after CO2 pneumoperitoneum in Trendelenburg position (T3), 60 min after CO2 pneumoperitoneum in Trendelenburg position (T4) and 5 min after the closure of pneumoperitoneum in supine position (T5).
Measured: 5 min before induction of anesthesia till 5 min after the closure of pneumoperitoneum
The incidence of postoperative adverse reactions
The incidence of adverse reactions, such as dizziness, postoperative nausea and vomiting (PONV) and postoperative headache (POHA) within 3 hours after surgery will be recorded in both groups.
Measured: Within 3 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start1 Feb 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LidocaineStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Rehab, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690087
- Sponsor's protocol ID
- 36204/12/22
- Status last verified
- Mar 2023
- First submitted
- 10 Jan 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Systemic Lidocaine Infusion on Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Hysterectomy in Trendelenburg Position
- ClinicalTrials.gov ID
- NCT05690087
- Acronym / sponsor ID
- 36204/12/22
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 19 Jan 2023 (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.
We hypothesize that intravenous lidocaine infusion may have beneficial effect to patients undergoing laparoscopic surgeries in Trendelenburg position by preventing ICP elevation.
Detailed description
Lidocaine use, both intravenous (IV) and laryngotracheal (LT), has been reported to blunt the ICP elevations during intubation. Also, Lidocaine injected IV has been shown in models to induce cerebral vasoconstriction leading to a decrease in cerebral blood volume and thus ICP. Furthermore, IV lidocaine leads to sodium channel inhibition and thus a reduction in cerebral activity and metabolic demands, as well as excitotoxicity, leading to a potential ICP reduction effect.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine group | Experimental | Drug: LidocaineIntravenous lidocaine 2% bolus of 1.5 mg/kg over 5 min before induction of anesthesia followed by lidocaine infusion at 1.5 mg/kg/h intraoperatively until desufflation. |
| Control group | Placebo comparator | Drug: sodium chloride 0.9% solutionIntravenous sodium chloride 0.9% solution volume matched in bolus and infusion. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 35 to 65 years
- American society of anesthesiology (ASA) physical status I - II
- Body mass index (BMI) between 18.5 to 28.0 kg/m2
- Scheduled for total laparoscopic hysterectomy taking approximately 2 h with a 30° Trendelenburg position for management of uterine fibroids or refractory dysfunctional uterine bleeding.
Key exclusion criteria (7 listed)
- Patients with eye diseases, central nervous system diseases, cardiovascular diseases, cerebrovascular diseases or diabetes.
- If these events occurred intraoperative:
- Patients with a history of allergy to lidocaine.
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 |
|---|---|---|
| Lidocaineintravenous lidocaine 2% bolus of 1.5 mg/kg over 5 min before induction of anesthesia followed by lidocaine infusion at 1.5 mg/kg/h intraoperatively until desufflation | Drug | Lidocaine group |
| sodium chloride 0.9% solutionintravenous sodium chloride 0.9% solution volume matched bolus and infusion. | Drug | Control group |
Primary outcome
Optic Nerve Sheath Diameter (ONSD)
Time frame: 5 min before induction of anesthesia till 5 min after the closure of pneumoperitoneum
ONSD at 5 min before induction of anesthesia in supine position (T1), 5 min after CO2 pneumoperitoneum in Trendelenburg position (T2), 30 min after CO2 pneumoperitoneum in Trendelenburg position (T3), 60 min after CO2 pneumoperitoneum in Trendelenburg position (T4) and 5 min after the closure of pneumoperitoneum in supine position (T5).
3 secondary outcomes
Heart rate
Time frame: 5 min before induction of anesthesia till 5 min after the closure of pneumoperitoneum
Mean arterial blood pressure
Time frame: 5 min before induction of anesthesia till 5 min after the closure of pneumoperitoneum
The incidence of postoperative adverse reactions
Time frame: Within 3 hours after surgery
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 3 Jan 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the corresponding author
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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. 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 Lidocaine and sodium chloride 0.9% solution in people with Lidocaine and Optic Nerve Sheath Diameter, run by Tanta 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 7 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 3 Jan 2024. 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?
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?
Optic Nerve Sheath Diameter (ONSD) (time frame: 5 min before induction of anesthesia till 5 min after the closure of pneumoperitoneum). 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 3 Jan 2024.