Back to resultsComparative Study Between Hydrocortisone and Mannitol in Treatment of Postdural Puncture Headache
Primary Purpose
Headache
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
hydrocortisone 100mg.
mannitol 20% intravenous fluid
Sponsored by
About this trial
This is an interventional treatment trial for Headache
Eligibility Criteria
Inclusion Criteria:
- aged 18-50 years old.
- both sex.
- ASA physical status I and II.
- 70-90 kg body weight.
- height 160-180 cm.
- Elective lower abdominal and pelvic surgery e.g. repair of inguinal hernia, repair of incisional hernia, varicocele and hydrocele.
Exclusion Criteria:
- Patients with impaired kidney or liver functions.
- history of cardiac or central nervous system disease.
- uncontrolled medical disease (diabetes mellitus and hypertension)
- history of intake of non-steroidal anti-inflammatory drugs or opioids within 24 h before surgery
- allergy to the used medications
- patient's refusal
- duration of surgery more than 120 minutes.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group (I) (N=25)
Group (II) (N=25)
Arm Description
Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours (Hydrocortisone as sodium succinate, vial, equivalent to hydrocortisone 100mg, Egyptian INT, Pharmaceutical Industries CO. ARE,EIPICO.EGYPT).
group (II), received mannitol 20% intravenous fluid (100ml intravenously which was given over 30 minutes and followed by 100 ml on a 12hour basis for 48 hours) (Manufactured by Allmed Middle East, Egypt).
Outcomes
Primary Outcome Measures
Number of Patients (in Digits) Got Earlier Relief of PDPH (in Hours) After Use of Hydrocortisone or Mannitol.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02760862
Brief Title
Comparative Study Between Hydrocortisone and Mannitol in Treatment of Postdural Puncture Headache
Official Title
Comparative Study Between Hydrocortisone and Mannitol in Treatment of Postdural Puncture Headache: a Randomized Double-blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
5. Study Description
Brief Summary
Fifty patients of both sex, aged 18-50 years and ASA I and II undergoing elective lower abdominal and pelvic surgery under spinal anesthesia were included in this randomized double-blind study. Patients were randomly divided into 2 groups 25 each; group (I) received intravenous hydrocortisone 100mg every 8 hours for 48 hours and group (II) received intravenous infusion of mannitol 20% 100ml over 30 minutes followed by 100ml every 12hours. Mean (+/- SD) of headache intensity at 0, 6, 12, 24 and 48 hours after beginning of treatment was assessed using visual analog scale.
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
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group (I) (N=25)
Arm Type
Active Comparator
Arm Description
Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours (Hydrocortisone as sodium succinate, vial, equivalent to hydrocortisone 100mg, Egyptian INT, Pharmaceutical Industries CO. ARE,EIPICO.EGYPT).
Arm Title
Group (II) (N=25)
Arm Type
Active Comparator
Arm Description
group (II), received mannitol 20% intravenous fluid (100ml intravenously which was given over 30 minutes and followed by 100 ml on a 12hour basis for 48 hours) (Manufactured by Allmed Middle East, Egypt).
Intervention Type
Drug
Intervention Name(s)
hydrocortisone 100mg.
Other Intervention Name(s)
(Hydrocortisone as sodium succinate, vial, equivalent to hydrocortisone 100mg, Egyptian INT, Pharmaceutical Industries CO. ARE,EIPICO.EGYPT)
Intervention Description
Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours
Intervention Type
Drug
Intervention Name(s)
mannitol 20% intravenous fluid
Other Intervention Name(s)
mannitol 20% (Manufactured by Allmed Middle East, Egypt).
Intervention Description
group (II), received mannitol 20% 100ml intravenously which was given over 30 minutes and followed by 100 ml on a 12hour basis. Urinary catheter was inserted for patients in group (II) under complete aseptic conditions by the anesthesia resident before the start of mannitol infusion and removed after its discontinuation, accompanied by the intravenous fluid infusion over 48 hours of 500ml of normal saline or Ringer's solution every 8 hours and the input/output fluid chart for evaluation of fluid balance.
Primary Outcome Measure Information:
Title
Number of Patients (in Digits) Got Earlier Relief of PDPH (in Hours) After Use of Hydrocortisone or Mannitol.
Time Frame
within 48 hours after starting of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 18-50 years old.
both sex.
ASA physical status I and II.
70-90 kg body weight.
height 160-180 cm.
Elective lower abdominal and pelvic surgery e.g. repair of inguinal hernia, repair of incisional hernia, varicocele and hydrocele.
Exclusion Criteria:
Patients with impaired kidney or liver functions.
history of cardiac or central nervous system disease.
uncontrolled medical disease (diabetes mellitus and hypertension)
history of intake of non-steroidal anti-inflammatory drugs or opioids within 24 h before surgery
allergy to the used medications
patient's refusal
duration of surgery more than 120 minutes.
12. IPD Sharing Statement
Learn more about this trial
Comparative Study Between Hydrocortisone and Mannitol in Treatment of Postdural Puncture Headache
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