Comparative Study Between Hydrocortisone and Mannitol in Treatment of Postdural Puncture Headache
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| ClinicalTrials.gov Identifier: NCT02760862 |
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Recruitment Status :
Completed
First Posted : May 4, 2016
Last Update Posted : May 4, 2016
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Sponsor:
Ain Shams University
Information provided by (Responsible Party):
Dr.Ibrahim Mamdouh Esmat, Ain Shams University
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Headache | Drug: hydrocortisone 100mg. Drug: mannitol 20% intravenous fluid | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Comparative Study Between Hydrocortisone and Mannitol in Treatment of Postdural Puncture Headache: a Randomized Double-blind Study |
| Study Start Date : | October 2014 |
| Actual Primary Completion Date : | November 2015 |
| Actual Study Completion Date : | November 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Headache
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Group (I) (N=25)
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).
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Drug: hydrocortisone 100mg.
Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours
Other Name: (Hydrocortisone as sodium succinate, vial, equivalent to hydrocortisone 100mg, Egyptian INT, Pharmaceutical Industries CO. ARE,EIPICO.EGYPT) |
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Active Comparator: Group (II) (N=25)
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).
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Drug: mannitol 20% intravenous fluid
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.
Other Name: mannitol 20% (Manufactured by Allmed Middle East, Egypt). |
Primary Outcome Measures :
- 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 ]
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
No Contacts or Locations Provided
| Responsible Party: | Dr.Ibrahim Mamdouh Esmat, Ain Shams University |
| ClinicalTrials.gov Identifier: | NCT02760862 History of Changes |
| Other Study ID Numbers: |
1102 |
| First Posted: | May 4, 2016 Key Record Dates |
| Last Update Posted: | May 4, 2016 |
| Last Verified: | May 2016 |
Additional relevant MeSH terms:
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Post-Dural Puncture Headache Headache Pain Neurologic Manifestations Signs and Symptoms Headache Disorders, Secondary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Hydrocortisone Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Hydrocortisone hemisuccinate Mannitol Anti-Inflammatory Agents Diuretics, Osmotic Diuretics Natriuretic Agents Physiological Effects of Drugs |