SevofluraneNCT07062367
Sevoflurane With or Without Intravenous Lidocaine Infusion Versus Propofol Anesthesia on Intracranial Pressure and Cerebral Oxygenation During Laparoscopic Hysterectomy
A study testing Propofol, Sevoflurane plus lidocaine infusion and Sevoflurane in people with Sevoflurane and Lidocaine, run by Tanta University at 1 site in Egypt.
Trial summary
This study will be conducted to evaluate the effects of different anesthetic modalities [sevoflurane with or without intraoperative lidocaine infusion and Propofol total intravenous anesthesia (TIVA)] on intracranial pressure (ICP) and cerebral oxygenation assessed by non-invasive methods during laparoscopic… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Sevoflurane, Lidocaine, Propofol
- What is being tested?
- Propofol, Sevoflurane plus lidocaine infusion and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 1 Feb 2027
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years.
- American Society of Anesthesiologists (ASA) physical status I and Ⅱ.
- Body mass index (BMI) ≤35.
- Females scheduled for laparoscopic hysterectomy.
Who cannot join
- Patients' refusal to participate in the study.
- Hypersensitivity and allergy to drugs of the study.
- Contraindication for optic nerve sheath diameter assessment. E.g., patient with pre-existing ophthalmic diseases, a history of ophthalmic surgery
- Any central nervous system or cardiovascular disease, severe hepatic or renal impairment
- Intraoperative circumstances, such as inability to perform optic nerve sheath diameter or conversion to open surgery
- If peak inspiratory pressure (PIP) exceeds 35.
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
Tanta University
Tanta, El-Gharbia, 31527
Eman A Elrefaey, Master, 00201008031402, eman.elrefaey@med.tanta.edu.eg
Hesham M Marof, MD
About this study
Official title: Effect of Sevoflurane With or Without Intravenous Lidocaine Infusion Versus Propofol Anesthesia on Intracranial Pressure and Cerebral Oxygenation During Laparoscopic Hysterectomy: A Randomized Controlled Study
This study will be conducted to evaluate the effects of different anesthetic modalities [sevoflurane with or without intraoperative lidocaine infusion and Propofol total intravenous anesthesia (TIVA)] on intracranial pressure (ICP) and cerebral oxygenation assessed by non-invasive methods during laparoscopic hysterectomy (LH).
Read the detailed description
Laparoscopic hysterectomy (LH) requires a Trendelenburg position (TP) and the creation of an artificial pneumoperitoneum (PP) by carbon dioxide insufflation.
Various studies were done to evaluate the effects of different anesthesia techniques on intracranial pressure (ICP) during LH, and most of these studies revealed that propofol total intravenous anesthesia (TIVA) was superior to inhaled anesthesia regarding reduction of ICP (ONSD).
- Conditions
- Sevoflurane, Lidocaine, Propofol, Intracranial Pressure, Cerebral Oxygenation, Laparoscopic Hysterectomy
- Being tested
- Propofol, Sevoflurane plus lidocaine infusion, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Patients' anesthesia will be maintained by manually adjusted propofol infusion at a rate of 100-250 mic/kg/min for bispectral index (BIS) maintained between 40-60.
Sevoflurane plus lidocaine infusionDrug
Sevoflurane with monitored anesthesia care (MAC) adjusted to maintain bispectral index (BIS) between 40-60 plus intravenous lidocaine infusion given as 2mg /kg IV bolus before induction then intraoperative infusion by a rate of 2 mg/kg/h until the end of surgery.
SevofluraneDrug
Patients will receive sevoflurane with monitored anesthesia care (MAC) adjusted to maintain bispectral index (BIS) between 40-60.
| Study group | Role | What they receive |
|---|---|---|
| Propofol group | Active comparator | Patients' anesthesia will be maintained by manually adjusted propofol infusion at a rate of 100-250 mic/kg/min for bispectral index (BIS) maintained between 40-60. Receives: Drug: Propofol |
| Sevoflurane plus lidocaine infusion group | Experimental | Sevoflurane with monitored anesthesia care (MAC) adjusted to maintain bispectral index (BIS) between 40-60 plus intravenous lidocaine infusion given as 2mg /kg IV bolus before induction then intraoperative infusion by a rate of 2 mg/kg/h until the end of surgery. Receives: Drug: Sevoflurane plus lidocaine infusion |
| Sevoflurane group | Experimental | Patients will receive sevoflurane with monitored anesthesia care (MAC) adjusted to maintain bispectral index (BIS) between 40-60. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve sheath diameter
Optic nerve sheath diameter of both eyes is expressed in millimeters and will be assessed at times of: T0; baseline before induction, T1; after insertion of endotracheal tube, T2; just before pneumoperitoneum (PP), T3;30 minutes after PP and Trendelenburg position (TP),T4; 60 minutes after PP and TP,T5; Five minutes after disinflation of PP and T6;after extubating the endotracheal tube.
Measured: After extubating the endotracheal tube (up to one hour)
Secondary outcomes (3)
Cerebral oxygenation
Cerebral oxygenation of both hemispheres by near-infrared spectroscopy (NIRS). normal values 60-70% and will be assessed at times of: T0; baseline before induction, T1; after insertion of endotracheal tube, T2; just before pneumoperitoneum (PP), T3;30 minutes after PP and Trendelenburg position (TP), T4; 60 minutes after PP and TP, T5; Five minutes after disinflation of PP and T6; after extubating the endotracheal tube.
Measured: After extubating the endotracheal tube (up to one hour)
Cognitive function
Cognitive function by standardized mini mental state examination (SMMSE) preoperative, and 4hours postoperatively.
Measured: 4 hours postoperatively
Incidence of postoperative complications
Incidence of postoperative complications such as hypotension, bradycardia, postoperative nausea and vomiting (PONV), and headache 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 posted14 Jul 2025
- Study start1 Feb 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SevofluraneStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Ali Abd-Elsamea Elrefaey, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062367
- Sponsor's protocol ID
- 36265MD329/12/24
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 14 Jul 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 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sevoflurane With or Without Intravenous Lidocaine Infusion Versus Propofol Anesthesia on Intracranial Pressure and Cerebral Oxygenation During Laparoscopic Hysterectomy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07062367
- Acronym / sponsor ID
- 36265MD329/12/24
- Conditions
- Sevoflurane, Lidocaine, Propofol, Intracranial Pressure, Cerebral Oxygenation, Laparoscopic Hysterectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 14 Jul 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 will be conducted to evaluate the effects of different anesthetic modalities [sevoflurane with or without intraoperative lidocaine infusion and Propofol total intravenous anesthesia (TIVA)] on intracranial pressure (ICP) and cerebral oxygenation assessed by non-invasive methods during laparoscopic hysterectomy (LH).
Detailed description
Laparoscopic hysterectomy (LH) requires a Trendelenburg position (TP) and the creation of an artificial pneumoperitoneum (PP) by carbon dioxide insufflation.
Various studies were done to evaluate the effects of different anesthesia techniques on intracranial pressure (ICP) during LH, and most of these studies revealed that propofol total intravenous anesthesia (TIVA) was superior to inhaled anesthesia regarding reduction of ICP (ONSD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Propofol group | Active comparator | Drug: PropofolPatients' anesthesia will be maintained by manually adjusted propofol infusion at a rate of 100-250 mic/kg/min for bispectral index (BIS) maintained between 40-60. |
| Sevoflurane plus lidocaine infusion group | Experimental | Drug: Sevoflurane plus lidocaine infusionSevoflurane with monitored anesthesia care (MAC) adjusted to maintain bispectral index (BIS) between 40-60 plus intravenous lidocaine infusion given as 2mg /kg IV bolus before induction then intraoperative infusion by a rate of 2 mg/kg/h until the end of surgery. |
| Sevoflurane group | Experimental | Drug: SevofluranePatients will receive sevoflurane with monitored anesthesia care (MAC) adjusted to maintain bispectral index (BIS) between 40-60. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18 to 65 years.
- American Society of Anesthesiologists (ASA) physical status I and Ⅱ.
- Body mass index (BMI) ≤35.
- Females scheduled for laparoscopic hysterectomy.
Key exclusion criteria (6 listed)
- Patients' refusal to participate in the study.
- Hypersensitivity and allergy to drugs of the study.
- Contraindication for optic nerve sheath diameter assessment. E.g., patient with pre-existing ophthalmic diseases, a history of ophthalmic surgery
- Any central nervous system or cardiovascular disease, severe hepatic or renal impairment
- Intraoperative circumstances, such as inability to perform optic nerve sheath diameter or conversion to open surgery
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 |
|---|---|---|
| PropofolPatients' anesthesia will be maintained by manually adjusted propofol infusion at a rate of 100-250 mic/kg/min for bispectral index (BIS) maintained between 40-60. | Drug | Propofol group |
| Sevoflurane plus lidocaine infusionSevoflurane with monitored anesthesia care (MAC) adjusted to maintain bispectral index (BIS) between 40-60 plus intravenous lidocaine infusion given as 2mg /kg IV bolus before induction then intraoperative infusion by a rate of 2 mg/kg/h until the end of surgery. | Drug | Sevoflurane plus lidocaine infusion group |
| SevofluranePatients will receive sevoflurane with monitored anesthesia care (MAC) adjusted to maintain bispectral index (BIS) between 40-60. | Drug | Sevoflurane group |
Primary outcome
Optic nerve sheath diameter
Time frame: After extubating the endotracheal tube (up to one hour)
Optic nerve sheath diameter of both eyes is expressed in millimeters and will be assessed at times of: T0; baseline before induction, T1; after insertion of endotracheal tube, T2; just before pneumoperitoneum (PP), T3;30 minutes after PP and Trendelenburg position (TP),T4; 60 minutes after PP and TP,T5; Five minutes after disinflation of PP and T6;after extubating the endotracheal tube.
3 secondary outcomes
Cerebral oxygenation
Time frame: After extubating the endotracheal tube (up to one hour)
Cognitive function
Time frame: 4 hours postoperatively
Incidence of postoperative complications
Time frame: 24 hours postoperatively
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 14 Jul 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.
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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 Propofol, Sevoflurane plus lidocaine infusion and Sevoflurane in people with Sevoflurane and Lidocaine, 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 6 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 14 Jul 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?
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?
Contact Eman A Elrefaey, Master (00201008031402, eman.elrefaey@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic nerve sheath diameter (time frame: After extubating the endotracheal tube (up to one hour)). 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 14 Jul 2025.