Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05108688

Collaborator

(none)

186

Enrollment

Location

Arms

Anticipated Duration (Months)

15.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Postdural puncture headache (PDPH) is a potential complication after spinal anesthesia caused by traction on pain-sensitive structures from low cerebrospinal fluid pressure (intracranial hypotension) following a leak of cerebrospinal fluid at the puncture site. Symptoms of this condition include a bilateral frontal or occipital headache that is worse in the upright position, along with nausea, neck pain, dizziness, visual changes, tinnitus, hearing loss, or radicular symptoms in the arms.

This study will examine the efficacy of mirtazapine in in the treatment of PDPH after obstetric surgery under spinal anesthesia and compared its efficacy with that of sumatriptan.

Condition or Disease	Intervention/Treatment	Phase
Headache	Drug: Mirtazapine Drug: Sumatriptan Other: Placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

186 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache Following Obstetric Surgery Under Spinal Anesthesia: A Randomized Controlled Trial

Actual Study Start Date :

Nov 15, 2021

Anticipated Primary Completion Date :

Nov 15, 2022

Anticipated Study Completion Date :

Nov 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mirtazapine Therapy group (M group)	Drug: Mirtazapine Mirtazapine 30 mg tablet once daily for 3 successive days
Active Comparator: Sumatriptan Therapy group (S group)	Drug: Sumatriptan Sumatriptan 50 mg tablet once daily for 3 successive days
Placebo Comparator: Control group ( C group)	Other: Placebo Placebo tablets once daily for 3 successive days.

Arm

Intervention/Treatment

Active Comparator: Mirtazapine Therapy group (M group)

Drug: Mirtazapine

Mirtazapine 30 mg tablet once daily for 3 successive days

Active Comparator: Sumatriptan Therapy group (S group)

Drug: Sumatriptan

Sumatriptan 50 mg tablet once daily for 3 successive days

Placebo Comparator: Control group ( C group)

Other: Placebo

Placebo tablets once daily for 3 successive days.

Outcome Measures

Primary Outcome Measures

Incidence of headache ((number of patients)(n),% of patients) [72 hours after intervention (Day 0)]
Incidence of headache ((number of patients)(n),% of patients) after 72 hours after intervention (Day 0)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

ASA I and II Patients.
Patients undergoing obstetric surgeries under spinal anesthesia. and complaining from moderate-to-severe PDPH after 25G spinal needle puncture.

Exclusion Criteria:

Refusal of the intervention or participation in the study.
Patient under age of 18 years old.
Psychiatric illness.
Patients with a history of ischemic heart disease, pregnancy-induced hypertension, chronic hypertension, cardiac, vascular, liver or renal impairment.
Patients with a history of migraine.
Patients with known hypersensitivity to study drugs.
Patients currently using ergotamine, monoamine oxidase inhibitors, or selective serotonin reuptake inhibitors.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain-Shams University Hospitals	Cairo		Egypt

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, Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt., Ain Shams University

ClinicalTrials.gov Identifier:

NCT05108688

Other Study ID Numbers: