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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.
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.
Age
18 - 45 years
Sex
FEMALE
Healthy Volunteers
Yes
Faculty of Medicine- Cairo University
Cairo, Egypt
Start Date
February 1, 2021
Primary Completion Date
February 1, 2022
Completion Date
May 1, 2022
Last Updated
May 28, 2021
274
ESTIMATED participants
Neostigmine
DRUG
Lead Sponsor
Cairo University
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07476053