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Comparative Study Between Hydrocortisone and Mannitol in Treatment of Postdural Puncture Headache

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ClinicalTrials.gov Identifier: NCT02760862
Recruitment Status : Completed
First Posted : May 4, 2016
Last Update Posted : May 4, 2016
Sponsor:
Information provided by (Responsible Party):
Dr.Ibrahim Mamdouh Esmat, Ain Shams University

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

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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


Arm Intervention/treatment
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).
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)

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).
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 :
  1. 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.

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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