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Nebulized Dexmedetomidine Versus Neostigmine/Atropine in Postdural Puncture Headache

Primary Purpose

Postdural Puncture Headache

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Neostigmine/atropine
Saline placebo
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postdural Puncture Headache

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

- Clinical diagnosis of postdural puncture headache (PDPH) after elective cesarean section under spinal anesthesia.

Exclusion Criteria:

  • Hypersensitivity of dexmedetomidine, neostigmine or atropine
  • Overactive thyroid gland
  • Myasthenia gravis
  • Closed angle glaucoma
  • High blood pressure and coronary artery disease.
  • withdrawal of consent

Sites / Locations

  • Assiut university hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Dexmedetomidine

Neostigmine/atropine

Saline placebo

Arm Description

Group D (patients will receive ultrasonic nebulization of dexmedetomidine (1 mg/kg diluted in 4 mL saline) twice daily for three days.

Group N (patients will receive nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine mixed in 4 ml) twice daily for three days.

Group S (patients will receive nebulization of saline placebo in 4 ml)twice daily for three days.

Outcomes

Primary Outcome Measures

visual analog scale score (VAS) ≤3 within 72 hour.
change in visual analog scale score (VAS )for the assessment of the degree of headache (with 0 representing no headache and 10 cm representing the worst imaginable headache). a visual analog scale score ≤3 within 72 hour after intervention will be recorded.

Secondary Outcome Measures

Need for Epidural blood patch
Epidural blood patch will be done in failed study drugs, traditional treatment and taking consent from patients after 72h from intervention
Occurence of neck stiffness
If there is occurance of neck stiffness after start of PDPH

Full Information

First Posted
May 25, 2021
Last Updated
September 5, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04910477
Brief Title
Nebulized Dexmedetomidine Versus Neostigmine/Atropine in Postdural Puncture Headache
Official Title
Comparative Effects of Nebulized Dexmedetomidine Versus Neostigmine / Atropine in Treating Postdural Puncture Headache After Cesarean Section: A Double Blind Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In our study, we will compare a new route of nebulization for effectiveness between dexmedetomidine, neostigmine/atropine and saline placebo for females complained of postdural puncture headache (PDPH) after cesarean section.
Detailed Description
A written informed consent will be taken from the patients. The study will involve female adults (age 18-40years) of American society of anesthesiologists (ASA) I-II who are listed for elective cesarean section under spinal anesthesia and suffer from postoperative postdural puncture headache (PDPH). Patients will be assigned randomly to three groups (30 subjects each) after PDPH diagnosis was established. First 90 patients developed PDPH will be assessed for study eligibility. Group D (patients will receive ultrasonic nebulization of dexmedetomidine (1 mg/kg diluted in 4 mL saline) twice daily for three days. Group N (patients will receive nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine mixed in 4 ml) twice daily for three days. Group S (patients will receive nebulization of saline placebo in 4 ml) twice daily for three days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postdural Puncture Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
Group D (patients will receive ultrasonic nebulization of dexmedetomidine (1 mg/kg diluted in 4 mL saline) twice daily for three days.
Arm Title
Neostigmine/atropine
Arm Type
Experimental
Arm Description
Group N (patients will receive nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine mixed in 4 ml) twice daily for three days.
Arm Title
Saline placebo
Arm Type
Placebo Comparator
Arm Description
Group S (patients will receive nebulization of saline placebo in 4 ml)twice daily for three days.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
ultrasonic nebulization of dexmedetomidine (1 mg/kg diluted in 4 mL saline) twice daily for three days.
Intervention Type
Drug
Intervention Name(s)
Neostigmine/atropine
Intervention Description
nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine mixed in 4 ml) twice daily for three days.
Intervention Type
Other
Intervention Name(s)
Saline placebo
Other Intervention Name(s)
Normal saline
Intervention Description
nebulization of saline placebo in 4 ml) twice daily for three days.
Primary Outcome Measure Information:
Title
visual analog scale score (VAS) ≤3 within 72 hour.
Description
change in visual analog scale score (VAS )for the assessment of the degree of headache (with 0 representing no headache and 10 cm representing the worst imaginable headache). a visual analog scale score ≤3 within 72 hour after intervention will be recorded.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Need for Epidural blood patch
Description
Epidural blood patch will be done in failed study drugs, traditional treatment and taking consent from patients after 72h from intervention
Time Frame
Day 4
Title
Occurence of neck stiffness
Description
If there is occurance of neck stiffness after start of PDPH
Time Frame
3 days

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female suffering from PDPH after cesarean section
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Clinical diagnosis of postdural puncture headache (PDPH) after elective cesarean section under spinal anesthesia. Exclusion Criteria: Hypersensitivity of dexmedetomidine, neostigmine or atropine Overactive thyroid gland Myasthenia gravis Closed angle glaucoma High blood pressure and coronary artery disease. withdrawal of consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Soliman
Organizational Affiliation
Omar makram
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university hospital
City
Assiut
ZIP/Postal Code
Assuit universi
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Nebulized Dexmedetomidine Versus Neostigmine/Atropine in Postdural Puncture Headache

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