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

NCT02760862 | Completed Phase 4 Results

• 1 other identifier: 1102
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Headache

Outcome Measures

Primary Outcomes (1)

• Number of Patients (in Digits) Got Earlier Relief of PDPH (in Hours) After Use of Hydrocortisone or Mannitol.

  within 48 hours after starting of treatment

Study Arms (2)

Group (I) (N=25)

ACTIVE COMPARATOR

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 (II) (N=25)

ACTIVE COMPARATOR

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

Interventions

hydrocortisone 100mg. DRUG

Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours

Also known as: (Hydrocortisone as sodium succinate, vial, equivalent to hydrocortisone 100mg, Egyptian INT, Pharmaceutical Industries CO. ARE,EIPICO.EGYPT)

Group (I) (N=25)

mannitol 20% intravenous fluid DRUG

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.

Also known as: mannitol 20% (Manufactured by Allmed Middle East, Egypt).

Group (II) (N=25)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• aged 18-50 years old.
• both sex.
• ASA physical status I and II.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Headache

Interventions

Hydrocortisone; Mannitol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Results Point of Contact

• Title: Dr. Ibrahim Mamdouh Esmat
• Organization: Ain-Shams University Hospitals

ibrahim_mamdouh@med.asu.edu.eg

01001241928

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Ibrahim Mamdouh Esmat

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: May 4, 2016
• Study Start: October 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: August 25, 2020
• Results First Posted: August 25, 2020

Record last verified: 2020-08