Opioid-based Versus Opioid-free Endotracheal Intubation

NCT06464393 | Completed

• 1 other identifier: 548/02-02-2024
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (18)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• ST segment change 1 minute post intubation

  ST segment elevation or depression after intubation

  1 minute after intubation

• ST segment change 3 minutes post intubation

  ST segment elevation or depression after intubation

  3 minutes after intubation

• ST segment change 5 minutes post intubation

  ST segment elevation or depression after intubation

  5 minutes after intubation

• 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

• 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

Study Arms (2)

ketamine-lidocaine-dexmedetomidine group

ACTIVE COMPARATOR

combination of ketamine-lidocaine-dexmedetomidine

Drug: ketamine-lidocaine-dexmedetomidine

fentanyl group

ACTIVE COMPARATOR

fentanyl

Drug: fentanyl

Interventions

ketamine-lidocaine-dexmedetomidine DRUG

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.

Also known as: KLD group

ketamine-lidocaine-dexmedetomidine group

fentanyl DRUG

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.

Also known as: control group

fentanyl group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aretaieion University Hospital: lead

Study Sites (1)

Aretaieion University Hospital

Athens, 11528, Greece

Location

Related Publications (5)

• 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.

  PMID: 3828177 BACKGROUND

• 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.

  PMID: 19357514 BACKGROUND

• 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.

  PMID: 36734737 BACKGROUND

• 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.

  PMID: 37515877 BACKGROUND

• 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.

  PMID: 38573179 BACKGROUND

MeSH Terms

Interventions

Fentanyl; Control Groups

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• KASSIANI THEODORAKI, PhD, DESA

  Aretaieion University Hospital, National and Kapodistrian University of Athens, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: March 20, 2024
• Primary Completion: March 20, 2025
• Study Completion: March 20, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)