Clinical trial

The Effect of a Regimen of Opioid Sparing Anesthesia on Postoperative Recovery

Name

254/13-07-2022Β

Description

The aim of this double blind randomized study will be to investigate the effect of an opioid-free anesthesia regimen with a mixture of lidocaine and ketamine in the same syringe versus remifentanyl analgesia in cervical spine surgery.

Trial arms

Trial start

2022-11-01

Estimated PCD

2024-11-01

Trial end

2024-11-01

Status

Recruiting

Treatment

ketamine-lidocaine

In the KL group, patients will be administered in a total volume of 20 mL,1mL/10 kg of the solution containing ketamine, lidocaine at predefined concentrations. As maintenance, they will be receiving 1mL/10kg/h of the aforementioned solution

Arms:

ketamine-lidocaine (KL) group combination of ketamine and lidocaine in one syringe

Other names:

KL group

Remifentanil

In the Remifentanil group, patients will be administered in a total volume of 20 mL, 2 mcg/kg of fentanyl. As maintenance, they will be receiving 1 mL/10kg/h of a remifentanil solution

Arms:

: remifentanil group syringe of remifentanil

Other names:

Remifentanil group

Size

Primary endpoint

pain score on arrival to Post-Anesthesia Care Unit (PACU)

immediately postoperatively]

pain score at discharge from Post-Anesthesia Care Unit (PACU)

at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively

pain score 3 hours postoperatively

3 hours postoperatively

pain score 6 hours postoperatively

6 hours postoperatively

pain score 24 hours postoperatively

24 hours postoperatively

Eligibility criteria

Inclusion Criteria: * Adult patents * American Society of Anesthesiologists (ASA) class I-III * elective spine surgery Exclusion Criteria: * body mass index (BMI) \>35 kg/m2 * contraindications to local anesthetic administration * systematic use of analgesic agents preoperatively * chronic pain syndromes preoperatively * neurological or psychiatric disease on treatment * pregnancy * severe hepatic or renal disease * history of cardiovascular diseases/ arrhythmias/ conduction abnormalities * bradycardia(\<55 beats/minute) * drug or alcohol abuse * language or communication barriers lack of informed consent

Protocol

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

Updated at

2023-02-08

1 organization

2 products

10 indications

Organization

Evangelismos Hospital

Product

ketamine-lidocaine

Indication

Pain

Indication