Clinical trial NCT06464393: Opioid-based Versus Opioid-free Endotracheal Intubation
Official title: The Effect of Opioid-free Anesthesia on Hemodynamic Response and Nociception Level Index During Laryngoscopy and Intubation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesia
Anesthesia Intubation
Opioid Use
Analgesic Non-narcotic
Fentanyl
Lead sponsor: Aretaieion University Hospital
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: change from baseline in systolic arterial pressure after premedication
timeFrame: 30 seconds after premedication
measure: change from baseline in systolic arterial pressure immediately after premedication
timeFrame: immediately after intubation
measure: change from baseline in systolic arterial pressure 1 minute after intubation
timeFrame: 1 minute after intubation
measure: change from baseline in systolic arterial pressure 3 minutes after intubation
timeFrame: 3 minutes after intubation
measure: change from baseline in systolic arterial pressure 5 minutes after intubation
timeFrame: 5 minutes after intubation
measure: change from baseline in diastolic arterial pressure after premedication
timeFrame: 30 seconds after premedication
measure: change from baseline in diastolic arterial pressure 1 minute after intubation
timeFrame: 1 minute after intubation
measure: change from baseline in diastolic arterial pressure 3 minutes after intubation
timeFrame: 3 minutes after intubation
measure: change from baseline in diastolic arterial pressure 5 minutes after intubation
timeFrame: 5 minutes after intubation
measure: change from baseline in heart rate after premedication
timeFrame: 30 seconds after premedication
measure: change from baseline in heart rate 1 minute after intubation
timeFrame: 1 minute after intubation
measure: change from baseline in heart rate 3 minutes after intubation
timeFrame: 3 minutes after intubation
measure: change from baseline in heart rate 5 minutes after intubation
timeFrame: 5 minutes after intubation
measure: ST segment change 1 minute post intubation
timeFrame: 1 minute after intubation
measure: ST segment change 3 minutes post intubation
timeFrame: 3 minutes after intubation
measure: ST segment change 5 minutes post intubation
timeFrame: 5 minutes after intubation
measure: duration of nociception level<25 for a 5-minute period after intubation
timeFrame: 5 minutes after intubation
measure: time required to achieve a train-of four-ratio of 0
timeFrame: within 2.5 minutes of neuromuscular blocking agent administration
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Aretaieion University Hospital
Study officials:
affiliation: Aretaieion University Hospital, National and Kapodistrian University of Athens, Greece
name: KASSIANI THEODORAKI, PhD, DESA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shribman AJ, Smith G, Achola KJ. Cardiovascular and catecholamine responses to laryngoscopy with and without tracheal intubation. Br J Anaesth. 1987 Mar;59(3):295-9. doi: 10.1093/bja/59.3.295.
citation: Theodoraki K, Fassoulaki A. Cardiovascular responses to laryngoscopy and tracheal intubation are not accompanied by ST-segment changes. Eur J Anaesthesiol. 2009 Jun;26(6):520-2. doi: 10.1097/EJA.0b013e32831a468d. No abstract available.
citation: Vickovic S, Zdravkovic R, Radovanovic D, Galambos IF, Pap D, Krtinic D, Stanisavljevic S, Preveden M, Videnovic N, Videnovic J. Effect of different doses of remifentanil on the cardiovascular response after endotracheal intubation: a randomized double-blind study. Eur Rev Med Pharmacol Sci. 2023 Jan;27(2):653-658. doi: 10.26355/eurrev_202301_31067.
citation: Feenstra ML, Jansen S, Eshuis WJ, van Berge Henegouwen MI, Hollmann MW, Hermanides J. Opioid-free anesthesia: A systematic review and meta-analysis. J Clin Anesth. 2023 Nov;90:111215. doi: 10.1016/j.jclinane.2023.111215. Epub 2023 Jul 27.
citation: Patel J, Snyder K, Brooks AK. Perioperative pain optimization in the age of the opioid epidemic. Curr Opin Anaesthesiol. 2024 Jun 1;37(3):279-284. doi: 10.1097/ACO.0000000000001370. Epub 2024 Mar 12.