The Effect of Dexmedetomidine Versus Lidocaine on Emergence Agitation.

Fayoum University

Status: Not yet enrolling

Conditions: Emergence Agitation

Treatments: Drug: Lidocaine; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT07355049

M786

Details and patient eligibility

About

The effect of intravenous dexmedetomidine versus intravenous lidocaine on the emergence agitation after endoscopic sinus surgery.

Full description

Endoscopic sinus surgery (ESS) is a common operation for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) when medical therapy alone is insufficient .

Early recovery from general anesthesia is accompanied by agitation, confusion, disorientation, and violent behavior, which is known as Emergence Agitation (EA). This post-anesthetic issue occurs in the early stages of General Anesthesia (GA) recovery, posing challenges in terms of both patient recovery delay and the complexities associated with assessment and management.

The incidence of EA varies, from approximately 0.25% to 90.5%, with age, assessment tool used, definitions, anesthetic techniques, type of surgery, and time of EA assessment during recovery .

Because the airway is contaminated with blood and the nasal airway is closed with surgical packs. ENT surgery is linked to a higher incidence of emerging agitation after nasal surgery.

Although EA is commonly self-limited and happens within the first 30 min of stay in a postanesthesia care unit (PACU) and also can lead to disconnection of monitoring devices or intravenous catheters, physical damage, falling, increase in the risk of bleeding, and self-extubation .

Several pharmacological methods have been used to mitigate EA, including opioid (fentanyl, remifentanil), propofol, benzodiazepine (midazolam), α2- aderenoreceptor agonist (clonidine, dexmedetomidine), and N-methy-d-aspar- tate (NMDA) receptor antagonist (ketamine, magnesium sulfate) administration.

Lidocaine is an amino amide-type short-acting local anesthetic (LA). It has a short half-life, and a favorable safety profile, and is therefore the LA of choice for continuous IV administration. Systemic lidocaine has been shown to be an effective adjunct strategy to reduce postoperative pain.

Dexmedetomidine is known as a highly selective α (2)-adrenoceptor agonist with sedative, anxiolytic, sympatholytic, and analgesic-sparing effects, which causes minimal depression of the respiratory function.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age : 18-60
• ASA Physical Status I or II
• Elective endoscopic sinus surgery under general anesthesia .

Exclusion criteria

• Refusal to participate
• Mental retardation or inability to communicate
• Allergy to anesthetics or study medications .
• Chronic use of beta blockers .
• significant hepatic, neurologic, cardiovascular or respiratory disease .
• BMI>35 kg/m2

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Group L

Active Comparator group

Description:

Active comparator group Group (L) recieves IV lidocaine 1.5mg/kg slowly before induction of anesthesia then lidocaine infusion starts at a rate of 2mg/kg/h

Treatment:

Drug: Lidocaine

Group D

Active Comparator group

Description:

Active comparator group (D) recieves IV dexmedetomidine bolus dose of 1mcg/kg over 10 minutes before induction of anesthesia followed by continous infusion at 0.4mcg/kg/h until the end of surgery

Treatment:

Drug: Dexmedetomidine