NCT06464393

Opioid-based Versus Opioid-free Endotracheal Intubation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Aretaieion University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anesthesia
• Anesthesia Intubation
• Opioid Use
• Analgesic Non-narcotic
• Fentanyl

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2024-03-20
• Primary completion: 2025-03-20
• Completion: 2025-03-20
• First posted: 2024-06-18
• Last updated: 2025-07-22

Locations

1 site across 1 country: Greece