Premedication and Haemodynamics After Spinal Anesthesia

The Influence of HRV-changing Premedication on Hemodynamic Parameters After Spinal Anesthesia

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01066247

Enrollment

Registered

2010-02-10

Start date

2009-09-30

Completion date

2010-06-30

Last updated

2011-07-26

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

Conditions

Hemodynamics After Spinal Anesthesia

Keywords

spinal anesthesia, heart rate variability, premedication, heart rate, blood pressure

Brief summary

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.

Interventions

DRUGMorphine hydrochloride; Midazolam

intramuscular morphine 10 mg given 30 minutes before spinal blockade performing

DRUGMidazolam

intramuscular midazolam 15 mg given 30 minutes before spinal blockade performing

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
hemodynamics after spinal anesthesia	one hour

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026