- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04709029
Effect of Intravenous Versus Intrathecal Dexamethazone on Postdural Puncture Headache
January 20, 2021 updated by: Ashraf Elsayed Elagamy, Ain Shams University
Effect of Intravenous Versus Intrathecal Dexamethazone in Bupivacaine Spinal Anesthesia on Postdural Puncture Headache
This study will be conducted at Ain Shams University Hospital in Operating Theatre after ethical committe approval number (MS 32/ 2020).
It is a prospective randomized controlled study will be done on patients undergoing lower abdominal and lower limb surgeries under spinal anethesia,Eligible patients will be randomized by computer system to one of two groups, either intravenous dexamethazzoe 8 mg with intrathecal heavy bupivacaine 0.5% or intrathecal 4mg dexamethazone with intrathecal heavy bupivacaine 0.5%. .
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Patients will be randomly divided into two equal groups: Group 1: patients receive intrathecal 3 ml bupivacaine 0. 5% +1 ml normal saline + intravenous 8 mg dexamethazone in 10 ml saline.
Group 2: patients receive intrathecal 3 ml bupivacaine 0. 5% + 4 mg (1 ml) dexamethazone + intravenous 10 ml normal saline.
Upon patients' arrival into the operating room, peripheral oxygen saturation (SPO2), ECG, pulse rate (PR), and systolic and diastolic blood pressures will be monitored one of the researchers and recorded every 5 minutes till the end of surgery.
In a sitting position and with antiseptic techniques, 25 G Quincke needle was inserted intrathecally at L3-L4 or L4-L5 interspace through midline approach.
The study drugs were given by an anesthesiologist not not aware of the type of medications injected.
Subsequently, the patients were put in the supine position, and given oxygen 3 L/minutes by nasal prongs.
Study Type
Interventional
Enrollment (Anticipated)
220
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ashraf Elagamy, E
- Phone Number: oo2o224701953
- Email: elagamy_ashraf@yahoo.com
Study Contact Backup
- Name: Dalia Elfawy
- Phone Number: 0020100401092
- Email: daliamfawy@yahoo.com
Study Locations
-
-
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Cairo, Egypt, 11566
- Ain Shams University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients ASA I or II undergoing lower limb surgeries under spinal anesthesia
- Patients ASAI or II undergoing lower abdominal surgeries under spinal anesthesia.
Exclusion Criteria:
- Emergency surgeries.
- Patients with uncompensated heart diseases.
- Patients with coagulopathy.
- Presence of infection at site of injection of spinal anesthesia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: intravenous dexamethazone group
Patients receive intrathecal 3 ml heavy bupivacaine 0. 5% +1 ml normal saline + intravenous 8 mg dexamethazone in 10 ml saline,to prevent postdural puncture headache.
Spinal anesthesia will be done in a sitting position under complete aseptic techniques, 25 G Quincke needle was inserted intrathecally at L3-L4 or L4-L5 interspace through midline approach.
The study drugs were given by an anesthesiologist not aware of the type of medications injected.
|
Evaluation of intravenous dexamethazone in prevention of postdural puncture headache
|
Active Comparator: intrathecal dexamethazone group
Patients receive intrathecal 3 ml heavy bupivacaine 0.5% + 4 mg (1 ml) dexamethazone + intravenous 10 ml normal saline to prevent postdural puncture headache.
Spinal anesthesia will be done in a sitting position under complete aseptic techniques, 25 G Quincke needle was inserted intrathecally at L3-L4 or L4-L5 interspace through midline approach.
The study drugs were given by an anesthesiologist not aware of the type of medications injected.
|
Evaluation of intrathecal dexamethazone in prevention of postdural puncture headache
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevention of postdural puncture headache
Time Frame: 48 hours after spinal anesthesia
|
prevention of postdural puncture headache after spinal anesthesia in the first 48 hours postoperatively
|
48 hours after spinal anesthesia
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of sensory block
Time Frame: 4 hours from injection of drug in subarachnoid space.
|
Duration of sensory block after spinal anesthesia from injection of drug till regain of sensation at level of T10
|
4 hours from injection of drug in subarachnoid space.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 20, 2021
Primary Completion (Anticipated)
May 20, 2021
Study Completion (Anticipated)
June 20, 2021
Study Registration Dates
First Submitted
January 12, 2021
First Submitted That Met QC Criteria
January 12, 2021
First Posted (Actual)
January 14, 2021
Study Record Updates
Last Update Posted (Actual)
January 22, 2021
Last Update Submitted That Met QC Criteria
January 20, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Headache Disorders
- Headache Disorders, Secondary
- Headache
- Post-Dural Puncture Headache
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Dexamethasone
- Dexamethasone acetate
- BB 1101
Other Study ID Numbers
- FMASU MS 32/2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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