Nebulized Dexmedetomidine Versus Neostigmine/Atropine in Postdural Puncture Headache

NCT ID: NCT04910477

Last Updated: 2021-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2021-09-03

Brief Summary

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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

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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.

Conditions

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Postdural Puncture Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Dexmedetomidine

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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

Neostigmine/atropine

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 Type EXPERIMENTAL

Neostigmine/atropine

Intervention Type DRUG

nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine mixed in 4 ml) twice daily for three days.

Saline placebo

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

Group Type PLACEBO_COMPARATOR

Saline placebo

Intervention Type OTHER

nebulization of saline placebo in 4 ml) twice daily for three days.

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Neostigmine/atropine

nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine mixed in 4 ml) twice daily for three days.

Intervention Type DRUG

Saline placebo

nebulization of saline placebo in 4 ml) twice daily for three days.

Intervention Type OTHER

Other Intervention Names

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Precedex Normal saline

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Omar Makram Soliman

Lecturer of anesthesia and ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Omar Soliman

Role: PRINCIPAL_INVESTIGATOR

Omar makram

Locations

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Assiut university hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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17300608

Identifier Type: -

Identifier Source: org_study_id

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