Comparison Of Different Doses Of Intrathecal Neostigmine In Prevention Of Post-Dural Puncture Headache
Primary Purpose
Headache
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Neostigmine
Sponsored by
About this trial
This is an interventional prevention trial for Headache
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.
Sites / Locations
- Faculty of Medicine- Cairo UniversityRecruiting
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04905953
Brief Title
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
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
274 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Neostigmine
Intervention Description
Intrathecal injection of two doses of neostigmine (10 & 20 mic) during spinal anesthesia for cesarean section.
Primary Outcome Measure Information:
Title
The incidence of PDPH following spinal anesthesia for cesarean section surgery.
Description
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.
Time Frame
72 hours.
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females candidate for elective cesarean section
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shymaa Fathy, MD
Phone
+201000455897
Ext
002
Email
angel6122003@yahoo.com
Facility Information:
Facility Name
Faculty of Medicine- Cairo University
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shymaa Fathy, MD
Phone
23649281
Ext
002
Email
pg@kasralainy.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30169405
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.
Results Reference
background
Learn more about this trial
Comparison Of Different Doses Of Intrathecal Neostigmine In Prevention Of Post-Dural Puncture Headache
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