Infertility FemaleLidoMagGynaNCT07359560
Lidocaine vs Magnesium Sulfate for Hemodynamic Stability During Emergence in Infertility-Related Laparoscopic Surgery"
A study testing Lidocaine (drug), Normal Saline (Intravenous) and magnesium sulfate in people with Infertility Female and Hemodynamic Instability, run by Zagazig University at 1 site in Egypt.
Trial summary
This study is being conducted to compare two medications, intravenous lidocaine and intravenous magnesium sulfate, and their ability to keep blood pressure and heart rate stable during the period of waking up from general anesthesia in infertility-related laparoscopic gynecologic surgeries. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility Female, Hemodynamic Instability
- What is being tested?
- Lidocaine (drug), Normal Saline (Intravenous) and magnesium sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2026to 2 Jul 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 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female patients aged 21 to 40 years
- Body mass index (BMI) between 18.5 and 29 kg/m²
- American Society of Anesthesiologists (ASA) physical status I or II
- Scheduled for elective infertility-related laparoscopic gynecologic surgery (e.g., diagnostic laparoscopy, ovarian cystectomy, adhesiolysis) under general anesthesia
- Expected duration of anesthesia less than 2 hours
- Ability to provide written informed consent
Who cannot join
- Known allergy or contraindication to lidocaine or magnesium sulfate
- History of significant cardiac, renal, or hepatic disease
- Chronic use of analgesics or history of drug dependence
- History of myasthenia gravis
- Pregnancy or positive serum β-hCG test
- -
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
Zagazig University Faculty of Medicine
Zagazig
Amira s Kenawy, lecturer, 01092014663, amira9981@gmail.com
About this study
Official title: Intravenous Lidocaine Versus Magnesium Sulfate for Hemodynamic Stability During Emergence From General Anesthesia in Infertility-related Laparoscopic Gynecologic Surgeries
This study is being conducted to compare two medications, intravenous lidocaine and intravenous magnesium sulfate, and their ability to keep blood pressure and heart rate stable during the period of waking up from general anesthesia in infertility-related laparoscopic gynecologic surgeries.
Laparoscopic gynecologic procedures can cause changes in heart rate and blood pressure, especially during emergence from anesthesia, and these changes may affect patient safety.
Read more
In this randomized, double-blind clinical trial, women scheduled for elective infertility-related laparoscopic surgery will be assigned to one of three groups: lidocaine, magnesium sulfate, or a control group. The study will evaluate mean arterial pressure (primary outcome), heart rate, pain scores, sedation level, nausea and vomiting, and any side effects during and after surgery.
The goal is to determine which medication provides better hemodynamic stability and improves recovery in the early postoperative period.
Read the detailed description
Laparoscopic gynecologic procedures performed for infertility are commonly associated with significant changes in heart rate and blood pressure, especially during the emergence phase of general anesthesia. These hemodynamic fluctuations may increase the risk of discomfort, delayed recovery, or cardiovascular complications. Several medications, including lidocaine and magnesium sulfate, have been suggested to help stabilize these responses because of their analgesic, sympatholytic, and cardioprotective properties. However, there is limited evidence comparing the two drugs in this specific surgical population.This prospective, randomized, double-blind controlled trial aims to evaluate the effects of intravenous lidocaine and intravenous magnesium sulfate on hemodynamic stability during emergence from general anesthesia in women undergoing elective infertility-related laparoscopic gynecologic surgeries. Participants will be randomly assigned to one of three groups: a lidocaine group, a magnesium sulfate group, or a control group receiving normal saline. Study medications will be administered 30 minutes before the anticipated time of extubation.
Hemodynamic measurements will be recorded throughout the perioperative period, with particular focus on mean arterial pressure during emergence (primary outcome). Secondary measures include heart rate, postoperative pain scores, sedation levels, nausea and vomiting, and any adverse events observed within the first 24 hours after surgery. All patients will receive standardized anesthesia management, monitoring, and postoperative care.
The goal of the study is to identify which medication is more effective in maintaining stable hemodynamics and improving early recovery following laparoscopic gynecologic surgery for infertility.
- Conditions
- Infertility Female, Hemodynamic Instability
- Being tested
- Lidocaine (drug), Normal Saline (Intravenous), magnesium sulfate
- Keywords
- lidocaine magnisium, hemodynamic instability, infertility female, laparoscopic surgery
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine (drug)Drug
Also called magnisium sulfate, saline
The intervention described in this clinical study involves a comparative prospective randomized double-blind controlled trial to assess the effects of intravenous Lidocaine versus Magnesium Sulfate compared to a Control group for hemodynamic stability during emergence from general anesthesia in infertility-related laparoscopic gynecologic surgeries.
Normal Saline (Intravenous)Drug
0.9% normal saline, total volume 15 mL, administered intravenously over 15 minutes starting 30 minutes before the anticipated time of extubation.
Lidocaine (drug)Drug
Lidocaine 1.5 mg/kg diluted with 0.9% normal saline to a total volume of 15 mL, administered intravenously over 15 minutes starting 30 minutes before the anticipated time of extubation.
magnesium sulfateDrug
Magnesium sulfate 30 mg/kg diluted with 0.9% normal saline to a total volume of 15 mL, administered intravenously over 15 minutes starting 30 minutes before the anticipated time of extubation.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Control Group (Normal Saline) | Placebo comparator | Participants in this arm will receive 15 mL of 0.9% normal saline intravenously over 15 minutes, starting 30 minutes before the anticipated time of extubation. This serves as the control intervention for comparison with lidocaine and magnesium sulfate. Receives: Drug: Normal Saline (Intravenous) |
| Arm 2: Lidocaine Group | Experimental | Participants in this arm will receive intravenous lidocaine at a dose of 1.5 mg/kg diluted with 0.9% normal saline to a total volume of 15 mL. The infusion will be administered over 15 minutes, starting 30 minutes before the expected time of extubation. Receives: Drug: Lidocaine (drug) |
| Arm 3: Magnesium Sulfate Group | Experimental | Participants in this arm will receive intravenous magnesium sulfate at a dose of 30 mg/kg diluted with 0.9% normal saline to a total volume of 15 mL. The infusion will be administered over 15 minutes, starting 30 minutes before the anticipated time of extubation. Receives: Drug: magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
the mean arterial pressure
MAP mean arterial pressure Measurement Schedule During Emergence MAP will be continuously monitored during the emergence phase of anesthesia. Recordings will be documented at minute 0 (the exact moment of extubation) and 5 minutes after extubation, starting from 5 minutes before extubation
Measured: 6 months
Secondary outcomes (4)
heart rate
HR heart rate serves as an important measure to determine how well the interventions (lidocaine or magnesium sulfate) manage hemodynamic stability during the delicate phase of emergence from anesthesia.
Measured: Preoperative: Baseline HR measurement. Intraoperative: 5 minutes after intubation. After Trendelenburg position. After pneumoperitoneum. Every 5 minutes for 30 minutes after infusion of lidocaine or magnesium sulfate. Emergence from Anesthesia:
Visual Analog Scale (VAS) for Pain
Pain intensity assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain intensity.
Measured: Visual Analog Scale (VAS) for Pain 30 minutes, 2 hours, and 6 hours postoperatively
Ramsay Sedation Score
assess the sedation level in patients recovering from general anesthesia during the postoperative period.The Ramsey Sedation Score is a 6-point scale used to assess the depth of sedation in patients. The score is based on the patient's responsiveness to verbal commands and physical stimuli, which allows clinicians to monitor sedation levels effectively.
Measured: Preoperative (if applicable): Baseline sedation status. Postoperative (PACU): On arrival in PACU: To assess the initial recovery from anesthesia. 30 minutes after arrival in PACU: To evaluate recovery progress and sedation changes. 6 hours postoperat
Incidence of Hypotension:
A decrease in Mean Arterial Pressure (MAP) by more than 20% from the baseline value
Measured: Immediately after induction of anesthesia (post-intubation): Blood pressure (MAP) will be measured to ensure the patient's cardiovascular system is stable after anesthesia induction. After placement in Trendelenburg position (head-down position): Th
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start2 Jan 2026 (estimated)
- Primary completion2 Jul 2026 (estimated)
- Study completion2 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility FemaleStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Model description
- Participants will be randomly allocated into three parallel groups to receive one of the study interventions (intravenous lidocaine, intravenous magnesium sulfate, or normal saline control). Each participant will receive only one intervention, and outcomes will be assessed independently for each group. Randomization and identical preparation of study drugs will maintain blinding of participants, anesthesia providers, and outcome assessors throughout the study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amira S kenawy ,md, Zagazig University
- Investigators
- Amira S Kenawy, lecturer, Principal investigator, Zagazig University Hospitals, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359560
- Sponsor's protocol ID
- ZU-IRB# 1904/2-Nov -2025
- Other IDs
- ethics commitee approval numbe
- Acronym
- LidoMagGyna
- Status last verified
- Dec 2025
- First submitted
- 6 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study is single-center, data contain sensitive patient information, and participant-level access is not planned."
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Lidocaine Versus Magnesium Sulfate for Hemodynamic Stability During Emergence From General Anesthesia in Infertility-related Laparoscopic Gynecologic Surgeries
- ClinicalTrials.gov ID
- NCT07359560
- Acronym / sponsor ID
- LidoMagGyna / ZU-IRB# 1904/2-Nov -2025
- Conditions
- Infertility Female, Hemodynamic Instability
- Keywords
- lidocaine magnisium, hemodynamic instability, infertility female, laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 2 Jan 2026 (estimated)
- Primary completion
- 2 Jul 2026 (estimated)
- Study completion
- 2 Jul 2026 (estimated)
- First posted
- 22 Jan 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.
This study is being conducted to compare two medications, intravenous lidocaine and intravenous magnesium sulfate, and their ability to keep blood pressure and heart rate stable during the period of waking up from general anesthesia in infertility-related laparoscopic gynecologic surgeries.
Laparoscopic gynecologic procedures can cause changes in heart rate and blood pressure, especially during emergence from anesthesia, and these changes may affect patient safety.
In this randomized, double-blind clinical trial, women scheduled for elective infertility-related laparoscopic surgery will be assigned to one of three groups: lidocaine, magnesium sulfate, or a control group. The study will evaluate mean arterial pressure (primary outcome), heart rate, pain scores, sedation level, nausea and vomiting, and any side effects during and after surgery.
The goal is to determine which medication provides better hemodynamic stability and improves recovery in the early postoperative period.
Detailed description
Laparoscopic gynecologic procedures performed for infertility are commonly associated with significant changes in heart rate and blood pressure, especially during the emergence phase of general anesthesia. These hemodynamic fluctuations may increase the risk of discomfort, delayed recovery, or cardiovascular complications. Several medications, including lidocaine and magnesium sulfate, have been suggested to help stabilize these responses because of their analgesic, sympatholytic, and cardioprotective properties. However, there is limited evidence comparing the two drugs in this specific surgical population.This prospective, randomized, double-blind controlled trial aims to evaluate the effects of intravenous lidocaine and intravenous magnesium sulfate on hemodynamic stability during emergence from general anesthesia in women undergoing elective infertility-related laparoscopic gynecologic surgeries. Participants will be randomly assigned to one of three groups: a lidocaine group, a magnesium sulfate group, or a control group receiving normal saline. Study medications will be administered 30 minutes before the anticipated time of extubation.
Hemodynamic measurements will be recorded throughout the perioperative period, with particular focus on mean arterial pressure during emergence (primary outcome). Secondary measures include heart rate, postoperative pain scores, sedation levels, nausea and vomiting, and any adverse events observed within the first 24 hours after surgery. All patients will receive standardized anesthesia management, monitoring, and postoperative care.
The goal of the study is to identify which medication is more effective in maintaining stable hemodynamics and improving early recovery following laparoscopic gynecologic surgery for infertility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly allocated into three parallel groups to receive one of the study interventions (intravenous lidocaine, intravenous magnesium sulfate, or normal saline control). Each participant will receive only one intervention, and outcomes will be assessed independently for each group. Randomization and identical preparation of study drugs will maintain blinding of participants, anesthesia providers, and outcome assessors throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Control Group (Normal Saline) | Placebo comparator | Drug: Normal Saline (Intravenous)Participants in this arm will receive 15 mL of 0.9% normal saline intravenously over 15 minutes, starting 30 minutes before the anticipated time of extubation. This serves as the control intervention for comparison with lidocaine and magnesium sulfate. |
| Arm 2: Lidocaine Group | Experimental | Drug: Lidocaine (drug)Participants in this arm will receive intravenous lidocaine at a dose of 1.5 mg/kg diluted with 0.9% normal saline to a total volume of 15 mL. The infusion will be administered over 15 minutes, starting 30 minutes before the expected time of extubation. |
| Arm 3: Magnesium Sulfate Group | Experimental | Drug: magnesium sulfateParticipants in this arm will receive intravenous magnesium sulfate at a dose of 30 mg/kg diluted with 0.9% normal saline to a total volume of 15 mL. The infusion will be administered over 15 minutes, starting 30 minutes before the anticipated time of extubation. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female patients aged 21 to 40 years
- Body mass index (BMI) between 18.5 and 29 kg/m²
- American Society of Anesthesiologists (ASA) physical status I or II
- Scheduled for elective infertility-related laparoscopic gynecologic surgery (e.g., diagnostic laparoscopy, ovarian cystectomy, adhesiolysis) under general anesthesia
- Expected duration of anesthesia less than 2 hours
Key exclusion criteria (6 listed)
- Known allergy or contraindication to lidocaine or magnesium sulfate
- History of significant cardiac, renal, or hepatic disease
- Chronic use of analgesics or history of drug dependence
- History of myasthenia gravis
- Pregnancy or positive serum β-hCG test
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 |
|---|---|---|
| Lidocaine (drug)Also: magnisium sulfate, salineThe intervention described in this clinical study involves a comparative prospective randomized double-blind controlled trial to assess the effects of intravenous Lidocaine versus Magnesium Sulfate compared to a Control group for hemodynamic stability during emergence from general anesthesia in infertility-related laparoscopic gynecologic surgeries. | Drug | Arm 2: Lidocaine Group |
| Normal Saline (Intravenous)0.9% normal saline, total volume 15 mL, administered intravenously over 15 minutes starting 30 minutes before the anticipated time of extubation. | Drug | Arm 1: Control Group (Normal Saline) |
| Lidocaine (drug)Lidocaine 1.5 mg/kg diluted with 0.9% normal saline to a total volume of 15 mL, administered intravenously over 15 minutes starting 30 minutes before the anticipated time of extubation. | Drug | Arm 2: Lidocaine Group |
| magnesium sulfateMagnesium sulfate 30 mg/kg diluted with 0.9% normal saline to a total volume of 15 mL, administered intravenously over 15 minutes starting 30 minutes before the anticipated time of extubation. | Drug | Arm 3: Magnesium Sulfate Group |
Primary outcome
the mean arterial pressure
Time frame: 6 months
MAP mean arterial pressure Measurement Schedule During Emergence MAP will be continuously monitored during the emergence phase of anesthesia. Recordings will be documented at minute 0 (the exact moment of extubation) and 5 minutes after extubation, starting from 5 minutes before extubation
4 secondary outcomes
heart rate
Time frame: Preoperative: Baseline HR measurement. Intraoperative: 5 minutes after intubation. After Trendelenburg position. After pneumoperitoneum. Every 5 minutes for 30 minutes after infusion of lidocaine or magnesium sulfate. Emergence from Anesthesia:
Visual Analog Scale (VAS) for Pain
Time frame: Visual Analog Scale (VAS) for Pain 30 minutes, 2 hours, and 6 hours postoperatively
Ramsay Sedation Score
Time frame: Preoperative (if applicable): Baseline sedation status. Postoperative (PACU): On arrival in PACU: To assess the initial recovery from anesthesia. 30 minutes after arrival in PACU: To evaluate recovery progress and sedation changes. 6 hours postoperat
Incidence of Hypotension:
Time frame: Immediately after induction of anesthesia (post-intubation): Blood pressure (MAP) will be measured to ensure the patient's cardiovascular system is stable after anesthesia induction. After placement in Trendelenburg position (head-down position): Th
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 22 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study is single-center, data contain sensitive patient information, and participant-level access is not planned."
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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.
Amira S Kenawy, lecturer principal investigator
Zagazig University Hospitals, Zagazig University
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 (drug), Normal Saline (Intravenous) and magnesium sulfate in people with Infertility Female and Hemodynamic Instability, run by Zagazig 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 6 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: opening soon, as of the sponsor's last update on 22 Jan 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?
Contact Amira S principal investigator, lecturer (01092014663, IRB_123@medicine.zu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the mean arterial pressure (time frame: 6 months). 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 22 Jan 2026.