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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04910477
Other study ID # 17300608
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 1, 2021
Est. completion date September 3, 2021

Study information

Verified date September 2021
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date September 3, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Intervention

Drug:
Dexmedetomidine
ultrasonic nebulization of dexmedetomidine (1 mg/kg diluted in 4 mL saline) twice daily for three days.
Neostigmine/atropine
nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine mixed in 4 ml) twice daily for three days.
Other:
Saline placebo
nebulization of saline placebo in 4 ml) twice daily for three days.

Locations

Country Name City State
Egypt Assiut university hospital Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 days
Secondary 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 Day 4
Secondary Occurence of neck stiffness If there is occurance of neck stiffness after start of PDPH 3 days
See also
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Suspended NCT02473276 - 2 Dose Neuraxial Morphine for Prevention of PDPH Phase 4
Completed NCT03652714 - The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache Phase 3
Completed NCT02859233 - Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache N/A
Withdrawn NCT02181205 - Sphenopalatine Ganglion Block for Post-Dural Puncture Headache N/A
Completed NCT01977898 - Incidence of Headache Following an Unintentional Dural Puncture N/A
Completed NCT06394024 - Examination of Postdural Puncture Headache Frequency, Predisposing Factors and Treatment
Withdrawn NCT03966547 - Changes in Cerebral Blood Flow (CBF) in Prone and Sitting Position Before and After GSP-block and Before and After Epidural Blood-patch: A Substudy of NCT03652714 N/A
Completed NCT06380764 - Greater Occipital Nerve Block Value in Management of Postdural Puncture Headache N/A
Terminated NCT02365909 - Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH) Early Phase 1
Completed NCT05969119 - Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache Phase 4
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Completed NCT00465166 - Lumbar Spine Ultrasound of Patients With Previous Accidental Dural Puncture During Labour Epidural N/A
Not yet recruiting NCT05212194 - The Relationship Between Post Dural Puncture Headache and Joint Laxity N/A
Completed NCT05777694 - Postdural Punction Headache After Ceserian Section N/A
Withdrawn NCT04515901 - Spenopalatine Ganglion Block for Treatment of Post-dural Puncture Headaches N/A
Completed NCT04892290 - Sphenopalatine Ganglion Block for Postdural Puncture Headache