Opioid-based Versus Opioid-free Endotracheal Intubation

Aretaieion University Hospital

Status: Completed

Conditions: Analgesic Non-narcotic; Fentanyl; Anesthesia Intubation; Opioid Use; Anesthesia

Treatments: Drug: fentanyl; Drug: ketamine-lidocaine-dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06464393

548/02-02-2024

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

ketamine-lidocaine-dexmedetomidine group

Active Comparator group

Description:

combination of ketamine-lidocaine-dexmedetomidine

Treatment:

Drug: ketamine-lidocaine-dexmedetomidine

fentanyl group

Active Comparator group

Description:

fentanyl

Treatment:

Drug: fentanyl