Clinical trial

The Effect of Opioid-free Anesthesia on Hemodynamic Response and Nociception Level Index During Laryngoscopy and Intubation

Name

548/02-02-2024

Description

The aim of this study will be to investigate the effect of opioid-free induction versus opioid-based induction on hemodynamic response and nociception level index during elective operations

Trial arms

Trial start

2024-03-20

Estimated PCD

2025-03-20

Trial end

2025-03-20

Status

Recruiting

Treatment

ketamine-lidocaine-dexmedetomidine

Patients will be administered 0,8 mcg/kg Dexmedetomidine in 100 mL of normal saline within 10 minutes as premedication. Followingly, they will receive 1mL/10 kg of the solution containing ketamine, lidocaine and dexmedetomidine at predefined concentrations just before induction of anesthesia.

Arms:

ketamine-lidocaine-dexmedetomidine group

Other names:

KLD group

fentanyl

Patients will be administered 2 mcg/kg fentanyl in 100 mL of normal saline within 10 minutes as premedication. Followingly, they will receive 1mL/10 kg of normal saline solution 0.9% just before induction of anesthesia.

Arms:

fentanyl group

Other names:

control group

Size

Primary endpoint

change from baseline in systolic arterial pressure after premedication

30 seconds after premedication

change from baseline in systolic arterial pressure immediately after premedication

immediately after intubation

change from baseline in systolic arterial pressure 1 minute after intubation

1 minute after intubation

change from baseline in systolic arterial pressure 3 minutes after intubation

3 minutes after intubation

change from baseline in systolic arterial pressure 5 minutes after intubation

5 minutes after intubation

change from baseline in diastolic arterial pressure after premedication

30 seconds after premedication

change from baseline in diastolic arterial pressure 1 minute after intubation

1 minute after intubation

change from baseline in diastolic arterial pressure 3 minutes after intubation

3 minutes after intubation

change from baseline in diastolic arterial pressure 5 minutes after intubation

5 minutes after intubation

change from baseline in heart rate after premedication

30 seconds after premedication

change from baseline in heart rate 1 minute after intubation

1 minute after intubation

change from baseline in heart rate 3 minutes after intubation

3 minutes after intubation

change from baseline in heart rate 5 minutes after intubation

5 minutes after intubation

ST segment change 1 minute post intubation

1 minute after intubation

ST segment change 3 minutes post intubation

3 minutes after intubation

ST segment change 5 minutes post intubation

5 minutes after intubation

duration of nociception level<25 for a 5-minute period after intubation

5 minutes after intubation

time required to achieve a train-of four-ratio of 0

within 2.5 minutes of neuromuscular blocking agent administration

Eligibility criteria

Inclusion Criteria: * adult patients * American Society of Anesthesiologists (ASA) classification I-II * Mallampati classification 1, 2 or 3 Exclusion Criteria: * anticipated difficult airway (Mallampati 4 classification, thyromental distance \< 6 cm, mouth opening \< 3 cm, neck extension\< 80 * atrioventricular block * bradycardia (heart rate less than 55/min) * preadministration of beta-blockers * eligibility for rapid-sequence induction * chronic use of opioid medications * known allergy to induction agents * history of psychiatric disease * language or communication barriers or 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

2024-06-18

1 organization

1 product

1 drug

5 indications

Organization

Aretaieion University Hospital

Product

ketamine-lidocaine-dexmedetomidine

Indication

Anesthesia