Opioid-based Versus Opioid-free Endotracheal Intubation

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06464393
• Other study ID #: 548/02-02-2024
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: March 20, 2025

Study information

• Verified date: June 2024
• Source: Aretaieion University Hospital
• Contact: Kassiani Theodoraki, PhD, DESA
• Phone: +306974634162
• Email: ktheodoraki[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 20, 2025
• Est. primary completion date: March 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Fentanyl
• Opioid Use

Intervention

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.
• 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.

Locations

Country	Name	City	State
Greece	Aretaieion University Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Aretaieion University Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	ST segment change 1 minute post intubation	ST segment elevation or depression after intubation	1 minute after intubation
Primary	ST segment change 3 minutes post intubation	ST segment elevation or depression after intubation	3 minutes after intubation
Primary	ST segment change 5 minutes post intubation	ST segment elevation or depression after intubation	5 minutes after intubation
Primary	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
Primary	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