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Intrathecal Administration of Levobupivacaine and Opioids in Elderly

NCT02385539 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2017-04-04

No results posted yet for this study

Summary

To find the optimal dose and combination of small dose of Levobupivacaine (LB) coadministered intrathecally with Fentanyl (F) or Sufentanil (S) with the highest probability for not developing hypotension and the lowest opioid side effect that would be sufficient to achieve and maintain a sensory block to the tenth thoracic dermatoma (T10) in elderly patients for surgery lasting \> 45 minutes as compared with large dose of Levobupivacaine alone.

Conditions

  • Adverse Reaction to Spinal Anesthetic

Interventions

DRUG

The impact of 10 independent variables on the likelihood of not developing hypotension after intrathecal injection.

The study will be conducted to assess the impact of a 10 independent variables (dose and combination of Levobupivacaine with Fentanyl or Sufentanil, age, basal systolic blood pressure (SBP), basal mean arterial pressure (MAP), time to lowest spinal SBP, upper limit of sensory block (dermatoma level), time intervals of sensory recovery for two consecutive dermatoma level (two-segment regression), time intervals of sensory recovery to the twelfth thoracic dermatoma (T12 regression), time intervals of sensory recovery to the first sacral dermatoma (S1 regression) and Body Mass Index) on the likelihood of not developing hypotension after intrathecal injection.

Sponsors & Collaborators

  • Šarić, Jadranka Pavičić, M.D.

    lead INDIV

Principal Investigators

  • Jadranka Pavičić Šarić, PhD · University Hospital Merkur

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
95 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-09-30
Completion
2016-09-30

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02385539 on ClinicalTrials.gov