Isobaric Spinal Ropivacaine Versus Hyperbaric Spinal Bupivacaine in Total Knee Arthroplasty in Geriatric Patients

M

Mohamed Sayed Mohamed Abbas

Status

Completed

Conditions

Spinal Anesthesia
Total Knee Arthroplasty in Geriatric Patients

Treatments

Drug: Isobaric ropivacaine
Drug: Hyperbaric bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02764723
MSAT-3

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of spinal anesthesia with isobaric ropivacaine, compared with hyperbaric bupivacaine in geriatric patients undergoing lower limb orthopedic surgery.

Full description

52 patients physical status II-III according to the American Society of Anesthesiologists classification aged 65 years and above of average height, and scheduled for total knee replacement under spinal anesthesia. Patients were randomly assigned into two equal groups of 26 patients each according to the type of local anesthetic injected in the subarachnoid space , Group I : patients who received an intrathecal injection of 12.5 mg of 0.5% hyperbaric bupivacaine , Group II: patients who received an intrathecal injection of 15 mg of 0.5% ropivacaine. The investigators compared both groups as regards the extent and duration of sensory and motor block and hemodynamics including heart rate (HR) , non invasive mean arterial blood pressure (MAP) and respiratory depression.

Enrollment

52 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

American Society of Anesthesiologists physical status II-III aged 65 years and above of average height, and scheduled for total knee replacement under spinal anesthesia.

Exclusion criteria

Known hypersensitivity to amide local anesthetics and contraindications to spinal anesthesia.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

52 participants in 2 patient groups

Hyperbaric bupivacaine
Active Comparator group
Description:
12.5 mg of 0.5% hyperbaric bupivacaine
Treatment:
Drug: Hyperbaric bupivacaine
Isobaric ropivacaine
Experimental group
Description:
15 mg of 0.5% isobaric ropivacaine
Treatment:
Drug: Isobaric ropivacaine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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