Opioid-based Versus Opioid-free Endotracheal Intubation

Not Applicable

Recruiting

• Conditions: Anesthesia; Fentanyl; Anesthesia Intubation; Opioid Use; Analgesic Non-narcotic
• Interventions: Drug: ketamine-lidocaine-dexmedetomidine; Drug: fentanyl

• Registration Number: NCT06464393
• Lead Sponsor: Aretaieion University Hospital

Brief 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

Detailed Description

Laryngoscopy and intubation stimuli can cause a sustained sympathetic response manifested as hypertension and tachycardia. Therefore, preadministration of opioid medication aiming at blunting this hemodynamic response is common in everyday anesthetic practice.

Opioid-based anesthesia is associated with side-effects, such as respiratory depression, postoperative nausea and vomiting and occasional induction of tolerance and hyperalgesia.

Research in recent years has focused on the quest for non-opioid-based regimens (opioid-sparing and opioid-free techniques). Most of the relevant studies however focus on the advantages that opioid-free techniques bear on early and late postoperative patient recovery. Literature on the effect of opioid-free techniques especially on laryngoscopy, intubation and subsequent hemodynamic response.

Therefore, the aim of this study will be the comparison of the hemodynamic response to laryngoscopy and intubation between two groups of patients: a group in which opioid medications will be administered before anesthetic induction and a group in which a combination of lidocaine, dexmedetomidine and ketamine will be administered before anesthetic induction.

Study Timeline

• Study Start: 2024-03-20
• Status Verified: 2024-06
• Study First Submitted: 2024-06-13
• Study First Submitted QC: 2024-06-13
• Last Update Submitted: 2024-06-13
• Study First Posted: 2024-06-18
• Last Update Posted: 2024-06-18
• Primary Completion: 2025-03-20
• Study Completion: 2025-03-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• adult patients
• American Society of Anesthesiologists (ASA) classification I-II
• Mallampati classification 1, 2 or 3

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ketamine-lidocaine-dexmedetomidine group	ketamine-lidocaine-dexmedetomidine	combination of ketamine-lidocaine-dexmedetomidine
fentanyl group	fentanyl	fentanyl

Primary Outcome Measures

Name	Time	Method
change from baseline in systolic arterial pressure after premedication	30 seconds after premedication	baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre
change from baseline in systolic arterial pressure immediately after premedication	immediately after intubation	baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre
change from baseline in systolic arterial pressure 3 minutes after intubation	3 minutes after intubation	baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre
change from baseline in systolic arterial pressure 5 minutes after intubation	5 minutes after intubation	baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre
change from baseline in diastolic arterial pressure after premedication	30 seconds after premedication	baseline diastolic arterial pressure will be measured as soon as the patient settles in the operating theatre
change from baseline in diastolic arterial pressure 1 minute after intubation	1 minute after intubation	baseline diastolic arterial pressure will be measured as soon as the patient settles in the operating theatre
change from baseline in systolic arterial pressure 1 minute after intubation	1 minute after intubation	baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre
change from baseline in diastolic arterial pressure 3 minutes after intubation	3 minutes after intubation	baseline diastolic arterial pressure will be measured as soon as the patient settles in the operating theatre
change from baseline in diastolic arterial pressure 5 minutes after intubation	5 minutes after intubation	baseline diastolic arterial pressure will be measured as soon as the patient settles in the operating theatre
change from baseline in heart rate after premedication	30 seconds after premedication	baseline heart rate will be measured as soon as the patient settles in the operating theatre
change from baseline in heart rate 1 minute after intubation	1 minute after intubation	baseline heart rate will be measured as soon as the patient settles in the operating theatre
change from baseline in heart rate 3 minutes after intubation	3 minutes after intubation	baseline heart rate will be measured as soon as the patient settles in the operating theatre
change from baseline in heart rate 5 minutes after intubation	5 minutes after intubation	baseline heart rate will be measured as soon as the patient settles in the operating theatre
ST segment change 1 minute post intubation	1 minute after intubation	ST segment elevation or depression after intubation
ST segment change 3 minutes post intubation	3 minutes after intubation	ST segment elevation or depression after intubation
ST segment change 5 minutes post intubation	5 minutes after intubation	ST segment elevation or depression after intubation
duration of nociception level<25 for a 5-minute period after intubation	5 minutes after intubation	nociception level (NOL) is a device that measures the status of analgesia intraoperatively. Levels\<25 suggest adequate intraoperatively analgesia
time required to achieve a train-of four-ratio of 0	within 2.5 minutes of neuromuscular blocking agent administration	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

Trial Locations

Locations (1)

Aretaieion University Hospital; 🇬🇷 Athens, Greece