Clinical trial NCT04905953: Comparison Of Different Doses Of Intrathecal Neostigmine In Prevention Of Post-Dural Puncture Headache
Official title: Comparison Of Different Doses Of Intrathecal Neostigmine In Prevention Of Post-Dural Puncture Headache: Prospective, Randomized, Controlled, Triple-blinded Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Headache
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 274
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients indicated for elective caesarean section surgery

Exclusion Criteria:

* Contraindications for regional anesthesia including local infection, hemorrhagic disorders, drug hypersensitivity, muscular disorders and central and peripheral neuropathy, and drug abuse history and addiction.

Primary outcomes:
measure: The incidence of PDPH following spinal anesthesia for cesarean section surgery.
timeFrame: 72 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine- Cairo University
Study officials:
References:
citation: 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.