Premedication and Haemodynamics After Spinal Anesthesia

Medical University of Gdansk

Status: Completed

Conditions: Hemodynamics After Spinal Anesthesia

Treatments: Drug: Midazolam; Drug: Morphine hydrochloride; Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT01066247

GUMed-Ow-001

Details and patient eligibility

About

Blood pressure drop following spinal anesthesia is connected with sympathetic/parasympathetic activity which may be determinated by Heart Rate Variability (HRV) assessment. Sympathetic predomination expressed as LF/HF ratio above 2.5 is strongly connected with deeper blood pressure fall. As drugs given for premedication may have impact on HRV variables, the investigators would like to determine if pharmacological premedication may modify hemodynamic changes following spinal blockade. Two drugs will be compared - midazolam which is known to lead to increase in LF/HF ratio and morphine - opioid which provokes opposite effect.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• spinal blockade for elective surgery

Exclusion criteria

• contraindications for spinal anesthesia
• hypertension
• heart failure
• chronic respiratory failure
• hypersensitivity for midazolam or morphine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Midazolam

Active Comparator group

Description:

intramuscular midazolam 15 mg given 30 minutes before spinal blockade performing

Treatment:

Drug: Midazolam

Morphine

Active Comparator group

Description:

intramuscular morphine 10 mg given 30 minutes before spinal blockade performing

Treatment:

Drug: Morphine hydrochloride; Midazolam