AnesthesiaNCT06464393
Opioid-based Versus Opioid-free Endotracheal Intubation
A study testing ketamine-lidocaine-dexmedetomidine and fentanyl in people with Anesthesia and Anesthesia Intubation, run by Aretaieion University Hospital at 1 site in Greece.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia, Anesthesia Intubation, Opioid Use
- What is being tested?
- ketamine-lidocaine-dexmedetomidine and fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGreece
- Study dates
- 20 Mar 2024to 20 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients
- American Society of Anesthesiologists (ASA) classification I-II
- Mallampati classification 1, 2 or 3
Who cannot join
- 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
Show all 9Show fewer
- known allergy to induction agents
- history of psychiatric disease
- language or communication barriers or lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Opioid-free Anesthesia on Hemodynamic Response and Nociception Level Index During Laryngoscopy and 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
Read the 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
- Being tested
- ketamine-lidocaine-dexmedetomidine, fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamine-lidocaine-dexmedetomidineDrug
Also called KLD group
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.
fentanylDrug
Also called control group
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.
| Study group | Role | What they receive |
|---|---|---|
| ketamine-lidocaine-dexmedetomidine group | Active comparator | combination of ketamine-lidocaine-dexmedetomidine Receives: Drug: ketamine-lidocaine-dexmedetomidine |
| fentanyl group | Active comparator | fentanyl Receives: Drug: fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 5 minutes after intubation
ST segment change 1 minute post intubation
ST segment elevation or depression after intubation
Measured: 1 minute after intubation
ST segment change 3 minutes post intubation
ST segment elevation or depression after intubation
Measured: 3 minutes after intubation
ST segment change 5 minutes post intubation
ST segment elevation or depression after intubation
Measured: 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
Measured: 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
Measured: within 2.5 minutes of neuromuscular blocking agent administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start20 Mar 2024
- Primary completion20 Mar 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aretaieion University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Kassiani Theodoraki, Aretaieion University Hospital
- Investigators
- KASSIANI THEODORAKI, PhD, DESA, Principal investigator, Aretaieion University Hospital, National and Kapodistrian University of Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464393
- Sponsor's protocol ID
- 548/02-02-2024
- Status last verified
- Jul 2025
- First submitted
- 13 Jun 2024
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 3828177Theodoraki 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.
PubMed 19357514Vickovic 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.
PubMed 36734737Feenstra 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.
PubMed 37515877Patel 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.
PubMed 38573179
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Opioid-free Anesthesia on Hemodynamic Response and Nociception Level Index During Laryngoscopy and Intubation
- ClinicalTrials.gov ID
- NCT06464393
- Acronym / sponsor ID
- 548/02-02-2024
- Conditions
- Anesthesia, Anesthesia Intubation, Opioid Use, Analgesic Non-narcotic, Fentanyl
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Aretaieion University HospitalUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketamine-lidocaine-dexmedetomidine group | Active comparator | Drug: ketamine-lidocaine-dexmedetomidinecombination of ketamine-lidocaine-dexmedetomidine |
| fentanyl group | Active comparator | Drug: fentanylfentanyl |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients
- American Society of Anesthesiologists (ASA) classification I-II
- Mallampati classification 1, 2 or 3
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ketamine-lidocaine-dexmedetomidineAlso: KLD groupPatients 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 | ketamine-lidocaine-dexmedetomidine group |
| fentanylAlso: control groupPatients 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. | Drug | fentanyl group |
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
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
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
ST segment change 1 minute post intubation
Time frame: 1 minute after intubation
ST segment elevation or depression after intubation
ST segment change 3 minutes post intubation
Time frame: 3 minutes after intubation
ST segment elevation or depression after intubation
ST segment change 5 minutes post intubation
Time frame: 5 minutes after intubation
ST segment elevation or depression after intubation
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Background: PubMed 3828177Shribman 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.
- Background: PubMed 19357514Theodoraki 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.
- Background: PubMed 36734737Vickovic 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.
- Background: PubMed 37515877Feenstra 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.
- Background: PubMed 38573179Patel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KASSIANI THEODORAKI, PhD, DESA principal investigator
Aretaieion University Hospital, National and Kapodistrian University of Athens, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ketamine-lidocaine-dexmedetomidine and fentanyl in people with Anesthesia and Anesthesia Intubation, run by Aretaieion University Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in systolic arterial pressure after premedication (time frame: 30 seconds after premedication). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06464393, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.