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

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02760862
• Collaborator: (none)
• Enrollment: 50
• Arms: 2
• Duration (Months): 13

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Headache	Drug: hydrocortisone 100mg.; Drug: mannitol 20% intravenous fluid	Phase 4

Study Design

• Study Type: Interventional
• 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: Oct 1, 2014
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

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 Names: (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 Names: mannitol 20% (Manufactured by Allmed Middle East, Egypt).

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr.Ibrahim Mamdouh Esmat, Dr.Ibrahim Mamdouh Esmat, Ain Shams University
• ClinicalTrials.gov Identifier: NCT02760862
• Other Study ID Numbers: 1102
• First Posted: May 4, 2016
• Last Update Posted: Aug 25, 2020
• Last Verified: Aug 1, 2020

• Additional relevant MeSH terms: Post-Dural Puncture Headache; Headache; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Mannitol

Study Results

Participant Flow

Arm/Group Title	Group (I) (N=25)	Group (II) (N=25)
Arm/Group 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). hydrocortisone 100mg.: Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours	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). 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.
Period Title: Overall Study
STARTED	25	25
COMPLETED	25	25
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Group (I) (N=25)	Group (II) (N=25)	Total
Arm/Group 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). hydrocortisone 100mg.: Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours	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). 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.	Total of all reporting groups
Overall Participants	25	25	50
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	25 100%	25 100%	50 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.4 (9.1)	35.1 (7.7)	35.4 (8.1)
Sex: Female, Male (Count of Participants)
Female	10 40%	11 44%	21 42%
Male	15 60%	14 56%	29 58%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
Egypt	25 100%	25 100%	50 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group (I) (N=25)	Group (II) (N=25)
Arm/Group 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). hydrocortisone 100mg.: Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours	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). 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.
Measure Participants	25	25
Count of Participants [Participants]	25 100%	25 100%

Adverse Events

Arm/Group Title	Group (I) (N=25)		Group (II) (N=25)
Arm/Group 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). hydrocortisone 100mg.: Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours		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). 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.
All Cause Mortality
	Group (I) (N=25)		Group (II) (N=25)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Group (I) (N=25)		Group (II) (N=25)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Group (I) (N=25)		Group (II) (N=25)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/25 (8%)		0/25 (0%)
Skin and subcutaneous tissue disorders
flushing	2/25 (8%)		0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.