Opioid-based Versus Opioid-free Endotracheal Intubation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-20

Study Completion Date

2025-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Atropine-effect During Propofol/Remifentanil Induction

NCT01871922

Anesthesia-induced Negative Hemodynamic Effects

COMPLETED NA

Prediction of Hemodynamic Reactivity During General Anesthesia Using Analgesia/Nociception Index (ANI)

NCT01839513

Anesthesia

COMPLETED

Response to Endotracheal Tube Intubation at Different Time of Fentanyl Given During Induction

NCT03728686

Intubation, Intratracheal

COMPLETED NA

Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery

NCT03120234

Opioid Free Anaesthesia

COMPLETED NA

Evaluation of the Effectiveness of the Administration of Local Anesthetics Via Two Catheters Placed During Surgery, and Study of the Benefits on Respiratory Function and Therefore on Recovery Time

NCT06463899

Duration of Hospitalization in Intensive Care Unit

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia Anesthesia Intubation Opioid Use Analgesic Non-narcotic Fentanyl

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ketamine-lidocaine-dexmedetomidine group

combination of ketamine-lidocaine-dexmedetomidine

Group Type ACTIVE_COMPARATOR

ketamine-lidocaine-dexmedetomidine

Intervention Type 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.

fentanyl group

fentanyl

Group Type ACTIVE_COMPARATOR

fentanyl

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

KLD group control group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No