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Efficacy of morphine as an adjuvant therapy to early anti-hypertensive drugs in intra-cerebral hemorrhage patients

Efficacy of morphine as an adjuvant therapy to early anti-hypertensive drugs in intra-cerebral hemorrhage patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210530051440N2
Enrollment
66
Registered
2022-12-14
Start date
2022-12-22
Completion date
Unknown
Last updated
2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intracerebral hemorrhage. Nontraumatic intracerebral hemorrhage

Interventions

Intervention 1: Intervention group: In patients allocated to the experimental group, the overall treatment principle is to apply sufficient morphine: morphine will be administered by 3 mg IV infusion

Sponsors

Zanjan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Acute stroke syndrome due to spontaneous ICH, which is defined as the sudden occurrence of bleeding into the parenchyma of the brain that may extend into the ventricles or subarachnoid space as confirmed by a clinical history and computed tomography (CT) scan Systolic BP =?150 mmHg at least twice (based on brachial artery pressure measured in the upper arm in two measurements conducted =?2 min apart) Age?>?18 years Feasible for emergency antihypertensive treatment and real-time BP monitoring Symptom onset within 24 h (if the time of onset is unknown, the last known time is selected) Special care unit (SCU) or stroke unit admission within 24 h

Exclusion criteria

Exclusion criteria: Subjects with contraindications for emergency-intensified antihypertensive treatment (such as severe carotid, vertebral or cerebral artery stenosis, known Moyamoya disease or multiple arteritis, and severe aortic stenosis or severe kidney failure) Intracranial hemorrhage secondary to intracranial tumor, recent trauma, cerebral infarction and thrombolytic therapy History of ischemic stroke within 30 days before disease onset The presence of dementia (previously diagnosed by a medical institution) or significant post-stroke disability (modified Rankin Scale (mRS) =?3 points [32]) pregnancy or lactating

Design outcomes

Primary

MeasureTime frame
Blood pressure control. Timepoint: Blood pressure will be controlled every 15 minutes for 2 hours at the start of treatment, then every 30 minutes for 6 hours, then every 1 hour for 16 hours, and then every 6 hours for a week. Method of measurement: Physical examination.;National Institutes of Health Stroke Scale (NIHSS) score. Timepoint: At Admission, 24 hours later and at discharge. Method of measurement: Physical Examination.;Modified Rankin Scale (MRS) score. Timepoint: At admission and 3 months after discharge. Method of measurement: Questionnaire.;Mortality. Timepoint: In-hospital and during 3 months after discharge. Method of measurement: Medical records and follow up information.

Secondary

MeasureTime frame
Mechanical ventilation rate. Timepoint: Within 2 days of hospitalization. Method of measurement: Clinical assessment.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAbdoreza Ghoreshi

Zanjan University of Medical Sciences

badalisooharahim@gmail.com+98 45 3361 0308

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026