HeadachePhase 2/3NCT04905953
Comparison Of Different Doses Of Intrathecal Neostigmine In Prevention Of Post-Dural Puncture Headache
A Phase 2/3 study testing Neostigmine in people with Headache, run by Cairo University at 1 site in Egypt.
Trial summary
We hypothesized that; intrathecal administration of neostgmine in spinal anesthesia may have a beneficial role in reduction of the incidence or severity of PDPH. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Headache
- What is being tested?
- Neostigmine
- Type of treatment
- Injection or infusion
- How many people
- 274 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 1 May 2022
- Phase
- Phase 2/3
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients indicated for elective caesarean section surgery
Who cannot join
- Contraindications for regional anesthesia including local infection, hemorrhagic disorders, drug hypersensitivity, muscular disorders and central and peripheral neuropathy, and drug abuse history and addiction.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine- Cairo University
Cairo, 11562
Shymaa Fathy, MD, 23649281 ext. 002, pg@kasralainy.edu.eg
About this study
Official title: Comparison Of Different Doses Of Intrathecal Neostigmine In Prevention Of Post-Dural Puncture Headache: Prospective, Randomized, Controlled, Triple-blinded Trial
We hypothesized that; intrathecal administration of neostgmine in spinal anesthesia may have a beneficial role in reduction of the incidence or severity of PDPH.
Read the detailed description
Neostigmine will be administered in two different doses (10 \& 20 mic) in addition to 10mg bupivicaine intrathecally for cesarean section compared to control group where 10 mg bupivicaine in addition to 20mic fentanyl will be administered intrathecally. The primary outcome will be detection of the incidence of postdural puncture headache (PDPH). A 25-gauge Quincke spinal needle will be used for spinal anesthesia.Patients indicated for elective caesarean section surgery will be included in the study. The exclusion criteria are contraindications for regional anesthesia including local infection, hemorrhagic disorders, drug hypersensitivity, muscular disorders and central and peripheral neuropathy, and drug abuse history and addiction.
Other outcomes will include age, ASA class, and duration of surgery. Sensory and motor function will be assessed every minute until T4 level is reached. Hemodynamic status (systolic and diastolic blood pressures, heart rate, and SPO2) will be recorded every 3 minutes throughout the surgery and then 4 hourly thereafter, for 24 h postoperatively. Recovery time from spinal anesthesia (return of motor power of both lower limbs) will be also recorded by anesthesiologist who is unaware of the group. Also the intra-operative and recovery phase complications including nausea, vomiting, itching, dyspnea, respiratory rate less than 10 per min, hypoxia (SPO2 less than 92% on room air), bradycardia (HR less than 60bpm), and hypotension (SPB less than 90) will be recorded.
Postoperative assessment will include pain scores "Overall 24-h VAS score", recorded at 30-min interval for first 4 h and then 4 hourly thereafter, for 24 h postoperatively.
- Conditions
- Headache
- Being tested
- Neostigmine
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeostigmineDrug
Intrathecal injection of two doses of neostigmine (10 \& 20 mic) during spinal anesthesia for cesarean section.
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of PDPH following spinal anesthesia for cesarean section surgery.
Diagnosis of PDPH is as follows, it is severe and described as "searing and spreading like hot metal," involving the back and front of the head, and spreading to the neck and shoulders, sometimes involving neck stiffness.
Measured: 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start1 Feb 2021
- Primary completion1 Feb 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HeadacheStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shymaa Fathy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905953
- Sponsor's protocol ID
- N-128-2020
- Status last verified
- May 2021
- First submitted
- 16 Mar 2021
- Last updated
- 28 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdelaal Ahmed Mahmoud A, Mansour AZ, Yassin HM, Hussein HA, Kamal AM, Elayashy M, Elemady MF, Elkady HW, Mahmoud HE, Cusack B, Hosny H, Abdelhaq M. Addition of Neostigmine and Atropine to Conventional Management of Postdural Puncture Headache: A Randomized Controlled Trial. Anesth Analg. 2018 Dec;127(6):1434-1439. doi: 10.1213/ANE.0000000000003734.
PubMed 30169405
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Different Doses Of Intrathecal Neostigmine In Prevention Of Post-Dural Puncture Headache: Prospective, Randomized, Controlled, Triple-blinded Trial
- ClinicalTrials.gov ID
- NCT04905953
- Acronym / sponsor ID
- N-128-2020
- Conditions
- Headache
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 28 May 2021 (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 hypothesized that; intrathecal administration of neostgmine in spinal anesthesia may have a beneficial role in reduction of the incidence or severity of PDPH.
Detailed description
Neostigmine will be administered in two different doses (10 \& 20 mic) in addition to 10mg bupivicaine intrathecally for cesarean section compared to control group where 10 mg bupivicaine in addition to 20mic fentanyl will be administered intrathecally. The primary outcome will be detection of the incidence of postdural puncture headache (PDPH). A 25-gauge Quincke spinal needle will be used for spinal anesthesia.Patients indicated for elective caesarean section surgery will be included in the study. The exclusion criteria are contraindications for regional anesthesia including local infection, hemorrhagic disorders, drug hypersensitivity, muscular disorders and central and peripheral neuropathy, and drug abuse history and addiction.
Other outcomes will include age, ASA class, and duration of surgery. Sensory and motor function will be assessed every minute until T4 level is reached. Hemodynamic status (systolic and diastolic blood pressures, heart rate, and SPO2) will be recorded every 3 minutes throughout the surgery and then 4 hourly thereafter, for 24 h postoperatively. Recovery time from spinal anesthesia (return of motor power of both lower limbs) will be also recorded by anesthesiologist who is unaware of the group. Also the intra-operative and recovery phase complications including nausea, vomiting, itching, dyspnea, respiratory rate less than 10 per min, hypoxia (SPO2 less than 92% on room air), bradycardia (HR less than 60bpm), and hypotension (SPB less than 90) will be recorded.
Postoperative assessment will include pain scores "Overall 24-h VAS score", recorded at 30-min interval for first 4 h and then 4 hourly thereafter, for 24 h postoperatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients indicated for elective caesarean section surgery
Key exclusion criteria (1 listed)
- Contraindications for regional anesthesia including local infection, hemorrhagic disorders, drug hypersensitivity, muscular disorders and central and peripheral neuropathy, and drug abuse history and addiction.
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 |
|---|---|---|
| NeostigmineIntrathecal injection of two doses of neostigmine (10 \& 20 mic) during spinal anesthesia for cesarean section. | Drug | – |
Primary outcome
The incidence of PDPH following spinal anesthesia for cesarean section surgery.
Time frame: 72 hours.
Diagnosis of PDPH is as follows, it is severe and described as "searing and spreading like hot metal," involving the back and front of the head, and spreading to the neck and shoulders, sometimes involving neck stiffness.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Background: PubMed 30169405Abdelaal Ahmed Mahmoud A, Mansour AZ, Yassin HM, Hussein HA, Kamal AM, Elayashy M, Elemady MF, Elkady HW, Mahmoud HE, Cusack B, Hosny H, Abdelhaq M. Addition of Neostigmine and Atropine to Conventional Management of Postdural Puncture Headache: A Randomized Controlled Trial. Anesth Analg. 2018 Dec;127(6):1434-1439. doi: 10.1213/ANE.0000000000003734.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Neostigmine in people with Headache, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 May 2021. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shymaa Fathy, MD (+201000455897 ext. 002, angel6122003@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of PDPH following spinal anesthesia for cesarean section surgery. (time frame: 72 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04905953, which also lists 1 linked publication.
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 28 May 2021.