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Completed

NCT Number: NCT06464393

Opioid-based Versus Opioid-free Endotracheal Intubation

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

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Key information

Conditions

Anesthesia Analgesic Non-narcotic Anesthesia Intubation Fentanyl Opioid Use

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aretaieion University Hospital

Athens, 11528, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: KLD 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.

Other names: control group

Primary outcomes

  1. change from baseline in systolic arterial pressure after premedication

    Time frame: 30 seconds after premedication

    baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre

  2. change from baseline in systolic arterial pressure immediately after premedication

    Time frame: immediately after intubation

    baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre

  3. change from baseline in systolic arterial pressure 1 minute after intubation

    Time frame: 1 minute after intubation

    baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre

  4. change from baseline in systolic arterial pressure 3 minutes after intubation

    Time frame: 3 minutes after intubation

    baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre

  5. change from baseline in systolic arterial pressure 5 minutes after intubation

    Time frame: 5 minutes after intubation

    baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre

  6. change from baseline in diastolic arterial pressure after premedication

    Time frame: 30 seconds after premedication

    baseline diastolic arterial pressure will be measured as soon as the patient settles in the operating theatre

  7. change from baseline in diastolic arterial pressure 1 minute after intubation

    Time frame: 1 minute after intubation

    baseline diastolic arterial pressure will be measured as soon as the patient settles in the operating theatre

  8. change from baseline in diastolic arterial pressure 3 minutes after intubation

    Time frame: 3 minutes after intubation

    baseline diastolic arterial pressure will be measured as soon as the patient settles in the operating theatre

  9. change from baseline in diastolic arterial pressure 5 minutes after intubation

    Time frame: 5 minutes after intubation

    baseline diastolic arterial pressure will be measured as soon as the patient settles in the operating theatre

  10. change from baseline in heart rate after premedication

    Time frame: 30 seconds after premedication

    baseline heart rate will be measured as soon as the patient settles in the operating theatre

  11. change from baseline in heart rate 1 minute after intubation

    Time frame: 1 minute after intubation

    baseline heart rate will be measured as soon as the patient settles in the operating theatre

  12. change from baseline in heart rate 3 minutes after intubation

    Time frame: 3 minutes after intubation

    baseline heart rate will be measured as soon as the patient settles in the operating theatre

  13. change from baseline in heart rate 5 minutes after intubation

    Time frame: 5 minutes after intubation

    baseline heart rate will be measured as soon as the patient settles in the operating theatre

  14. ST segment change 1 minute post intubation

    Time frame: 1 minute after intubation

    ST segment elevation or depression after intubation

  15. ST segment change 3 minutes post intubation

    Time frame: 3 minutes after intubation

    ST segment elevation or depression after intubation

  16. ST segment change 5 minutes post intubation

    Time frame: 5 minutes after intubation

    ST segment elevation or depression after intubation

  17. duration of nociception level<25 for a 5-minute period after intubation

    Time frame: 5 minutes after intubation

    nociception level (NOL) is a device that measures the status of analgesia intraoperatively. Levels<25 suggest adequate intraoperatively analgesia

  18. time required to achieve a train-of four-ratio of 0

    Time frame: within 2.5 minutes of neuromuscular blocking agent administration

    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

Sponsors and collaborators

Lead sponsor

Aretaieion University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2024
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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