The Effect of Opioid-free Anesthesia on Hemodynamic Response and Nociception Level Index During Laryngoscopy and Intubation
Overview
- Phase
- Not Applicable
- Intervention
- ketamine-lidocaine-dexmedetomidine
- Conditions
- Anesthesia
- Sponsor
- Aretaieion University Hospital
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- change from baseline in systolic arterial pressure after premedication
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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.
Investigators
Dr Kassiani Theodoraki
Professor of Anesthesiology
Aretaieion University Hospital
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
Arms & Interventions
ketamine-lidocaine-dexmedetomidine group
combination of ketamine-lidocaine-dexmedetomidine
Intervention: ketamine-lidocaine-dexmedetomidine
fentanyl group
fentanyl
Intervention: fentanyl
Outcomes
Primary Outcomes
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 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 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 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