Clinical trial

A Comparative Study Between Intrathecal Dexmedetomidine VS Ketamine With Intrathecal Bupivacaine in Orthopedic Lower Limb Surgeries.

Name

Soh-Med-23-02-09

Description

Orthopedic anaesthesia and acute postoperative pain management, two anesthesiology subspecialties,are getting more credit for reducing hospital stays, promoting functional recovery and improving patient satisfaction.

Trial arms

Trial start

2023-03-01

Estimated PCD

2024-02-01

Trial end

2024-02-28

Status

Not yet recruiting

Treatment

Dexmedetomidine

(50 patients) will receive calculated dose of intrathecal hyperbaric bupivacaine 0.5 % according to body weight and 5μg Dexametomidine.

Arms:

Group D

Ketamine

(50 patients) will receive calculated dose of intrathecal hyperbaric bupivacaine 0.5 % according to body weight and 0.1 mg/kg ketamine.

Arms:

Group K

Size

100

Primary endpoint

comparison between duration of analgesia from Ketamine Vs Dexmedtomidine in the Patients with lower limb surgery

1 year

Eligibility criteria

Inclusion Criteria: -The study will include 100 adult patients (18 to 50 years old) with ASA physical status class I and class II undergoing orthopedic lower limb surgeries under itrathecal anathesia . Exclusion Criteria: * Patient refusal. * Drug abuse. * Patient with neurological, psychiatric or neuromuscular disease. * Chronic pain on medicine. * Known allergy to the study medications. * Patients e contraindications to intrathecal anesthesia .

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2023-03-02

1 organization

1 product

1 drug

1 indication

Organization

Product

Indication

Drug