Clinical trial

Opioid-free Anesthesia With a Mixture of Dexmedetomidine-lidocaine-ketamine in Laparoscopic Cholecystectomies

Name

lap-chol-opioid free

Description

The aim of this study will be to investigate the effect of an opioid-free anesthesia regimen with a mixture of dexmedetomidine-lidocaine-ketamine in the same syringe versus fentanyl analgesia in elective laparoscopic cholecystectomies

Trial arms

Trial start

2021-10-11

Estimated PCD

2023-06-30

Trial end

2023-06-30

Status

Recruiting

Treatment

ketamine-lidocaine-dexmedetomidine

In the KLD group, patients will be administered 0,25 mcg/kg Dexmedetomidine in 100 mL of normal saline within 10 minutes. Followingly, they will receive 1mL/10 kg of the solution containing ketamine, lidocaine and dexmedetomidine at predefined concentrations. As maintenance, they will be receiving 1mL/10kg/h of the aforementioned solution.

Arms:

ketamine-lidocaine-dexmedetomidine (KLD) group

Other names:

KLD group

fentanyl

In the fentanyl group, patients will be administered 2 mcg/kg fentanyl in 100 mL of normal saline within 10 minutes. Followingly, they will receive 1mL/10 kg of normal saline solution 0.9%. As maintenance, they will be receiving 1mL/10kg/h of normal saline solution 0.9%.

Arms:

fentanyl (control) group

Other names:

Control 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 patients * American Society of Anesthesiologists (ASA) classification I-II * elective laparoscopic cholecystectomy Exclusion Criteria: * body mass index (BMI) \>35 kg/m2 * contraindications to local anesthetic administration or non-steroidal agents 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': 70, 'type': 'ESTIMATED'}}

Updated at

2023-02-24

1 organization

1 product

1 drug

11 indications

Organization

Aretaieion University Hospital

Product

ketamine-lidocaine-dexmedetomidine

Indication

Pain