Comparison Of Different Doses Of Intrathecal Neostigmine In Prevention Of Post-Dural Puncture Headache
NCT ID: NCT04905953
Last Updated: 2021-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
274 participants
INTERVENTIONAL
2021-02-01
2022-05-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Interventions
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Neostigmine
Intrathecal injection of two doses of neostigmine (10 \& 20 mic) during spinal anesthesia for cesarean section.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
45 Years
FEMALE
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Shymaa Fathy
Lecturer of anesthesia and SICU
Locations
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Faculty of Medicine- Cairo University
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Shymaa Fathy, MD
Role: primary
References
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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.
Other Identifiers
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N-128-2020
Identifier Type: -
Identifier Source: org_study_id