Opioid-based Versus Opioid-free Endotracheal Intubation
NCT Number: NCT06464393
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anesthesia|Anesthesia Intubation|Opioid Use|Analgesic Non-narcotic|Fentanyl
Interventions: DRUG: ketamine-lidocaine-dexmedetomidine|DRUG: fentanyl
Sponsor: Aretaieion University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-03-20
Completion Date: 2025-03-20
Locations: Aretaieion University Hospital, Athens, 11528, Greece

Summary:
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

Primary Outcome Measures: change from baseline in systolic arterial pressure after premedication, baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre, 30 seconds after premedication|change from baseline in systolic arterial pressure immediately after premedication, baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre, immediately after intubation|change from baseline in systolic arterial pressure 1 minute after intubation, baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre, 1 minute after intubation|change from baseline in systolic arterial pressure 3 minutes after intubation, baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre, 3 minutes after intubation|change from baseline in systolic arterial pressure 5 minutes after intubation, baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre, 5 minutes after intubation|change from baseline in diastolic arterial pressure after premedication, baseline diastolic arterial pressure will be measured as soon as the patient settles in the operating theatre, 30 seconds after premedication|change from baseline in diastolic arterial pressure 1 minute after intubation, baseline diastolic arterial pressure will be measured as soon as the patient settles in the operating theatre, 1 minute after intubation|change from baseline in diastolic arterial pressure 3 minutes after intubation, baseline diastolic arterial pressure will be measured as soon as the patient settles in the operating theatre, 3 minutes after intubation|change from baseline in diastolic arterial pressure 5 minutes after intubation, baseline diastolic arterial pressure will be measured as soon as the patient settles in the operating theatre, 5 minutes after intubation|change from baseline in heart rate after premedication, baseline heart rate will be measured as soon as the patient settles in the operating theatre, 30 seconds after premedication|change from baseline in heart rate 1 minute after intubation, baseline heart rate will be measured as soon as the patient settles in the operating theatre, 1 minute after intubation|change from baseline in heart rate 3 minutes after intubation, baseline heart rate will be measured as soon as the patient settles in the operating theatre, 3 minutes after intubation|change from baseline in heart rate 5 minutes after intubation, baseline heart rate will be measured as soon as the patient settles in the operating theatre, 5 minutes after intubation|ST segment change 1 minute post intubation, ST segment elevation or depression after intubation, 1 minute after intubation|ST segment change 3 minutes post intubation, ST segment elevation or depression after intubation, 3 minutes after intubation|ST segment change 5 minutes post intubation, ST segment elevation or depression after intubation, 5 minutes after intubation|duration of nociception level<25 for a 5-minute period after intubation, nociception level (NOL) is a device that measures the status of analgesia intraoperatively. Levels\<25 suggest adequate intraoperatively analgesia, 5 minutes after intubation|time required to achieve a train-of four-ratio of 0, the train-of-four (TOF) ratio measures the ratio of the fourth stimulus to the first stimulus of four twitches of neuromuscular stimulation. When this ration reaches the value of 0, the patient is considered ready for intubation, within 2.5 minutes of neuromuscular blocking agent administration