Clinical trial

Multimodal Opioid-free Anesthesia Versus Opioid-based Anesthesia for Patients Undergoing Cardiac Valve Surgeries: A Randomized Controlled Trial

Name

MD-242-2019

Description

Several studies demonstrated the effectiveness of OFA in patients undergoing non-cardiac surgery. Preoperative use of Cox inhibitors, GABA analogues and acetaminophen have been shown to decrease use of opioids postoperatively . Intraoperative use of agents that lead to opioid sparing effects via sodium channel blockade, blockade of G protein-coupled receptors, NMDA blockade, central alpha-2 agonists and anti-inflammatory effects can make opioid-free anesthesia (OFA) possible. On the other hand, there have been no studies demonstrating the effectiveness of an OFA technique in patients undergoing cardiac surgery except for two case reports who successfully implemented the OFA regimen in two patients undergoing valve replacement surgeries. The investigators therefore propose this prospective randomized controlled trial to investigate whether a multimodal opioid-free anesthesia regimen will be suitable as an alternative to conventional opioid-based regimen in patients undergoing valve surgery

Trial arms

Trial start

2020-12-01

Estimated PCD

2022-08-01

Trial end

2022-10-01

Status

Completed

Phase

Early phase I

Treatment

Dexmedetomidine 0.5 mic/kg/h

In Group I (OFA) the following drugs will be administered preoperatively: Acetaminophen 1 gm and Ketorolac 30 mg in 100 mL i.v. over 10 minutes Dexmedetomidine loading dose of 0.5 mic/kg i.v. over 10 minutes Lidocaine loading dose of 1.5 mg/kg i.v. over 10 minutes The following drugs will be administered as a continuous infusion throughout the operation: * Dexmedetomidine 0.5 mic/kg/h * Lidocaine 0.5 mg/kg/h The following drugs will be administered postoperatively: Acetaminophen 1 gm/6h ketorolac 30 mg/8h Pregabalin 150 mg once at night Celecoxib 200 mg/24 hours

Arms:

Opioid-Free Anesthesia (OFA)

Other names:

Lidocaine 0.5 mg/kg/h, Pregabalin 150 mg, Acetaminophen 1g, Ketorolac 30 mg, Celecoxib 200 mg

Fentanyl 1 mic/kg/hr

In Group II (OA) patients will receive a continuous infusion of Fentanyl (1 mic/kg/h) Morphine 0.1 mg/kg PRN will be administered every 8 hours for postoperative analgesia

Arms:

Opioid Anesthesia (OA)

Other names:

Morphine 0.1 mg/kg/hr

Size

Primary endpoint

Extubation time (min)

24 hours

Eligibility criteria

Inclusion Criteria: 1. Patients undergoing cardiac valve surgeries ( replacement or repair ) . 2. Age (18-80) years 3. Both sexes Exclusion Criteria: * Patient refusal * Known allergy to any of the medications used in the study * Combined valve and CABG surgeries * Redo surgery * Infective endocarditis * Patients in heart failure or heart block or with significant systolic dysfunction (EF \< 40%) or diastolic dysfunction more than grade II * Pregnant females * Patients being treated for chronic pain or with recent use (\< two weeks) of opioids, gabapentin, or pregabalin. * Substance abuse * Patients with renal impairment (creatinine \> 2 mg/dL) or hepatic impairment (ALT \> 2 folds, INR \> 1.5 and/or serum albumin \< 2.5 g/dl)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

Updated at

2023-08-30

1 organization

2 products

1 indication

Organization

Product

Indication

Product