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

NCT ID: NCT02760862

Last Updated: 2020-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

hydrocortisone 100mg.

Intervention Type: DRUG

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

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).

Group Type: ACTIVE_COMPARATOR

mannitol 20% intravenous fluid

Intervention Type: 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.

Interventions

hydrocortisone 100mg.

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

(Hydrocortisone as sodium succinate, vial, equivalent to hydrocortisone 100mg, Egyptian INT, Pharmaceutical Industries CO. ARE,EIPICO.EGYPT); mannitol 20% (Manufactured by Allmed Middle East, Egypt).

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Dr.Ibrahim Mamdouh Esmat

Dr.Ibrahim Mamdouh Esmat

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

1102

Identifier Type: -

Identifier Source: org_study_id