Effects of Lidocaine Infusion on Quality of Recovery and Agitation After Functional Endoscopic Sinus Surgery

Alexandria University

Status: Unknown

Conditions: Chronic Polypous Rhinosinusitis

Treatments: Drug: Lidocaine; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04472689

0304701

Details and patient eligibility

About

The essential anesthesia requirements for FESS include airway management, considerations for facilitating surgical access, provision of a clear and still surgical field for precision surgery, assuring quick and non-stimulating emergence from anesthesia, and fast-tracking patients for discharge. Postoperative agitation, although short-lived, is potentially harmful to both patients and recovery room staff, it has a potential for self-injury by removing intravenous catheters, tubing, oxygen masks and nasal packs. Furthermore, very agitated patients can pose an immediate danger to operating theatre staff.

Full description

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, it has analgesic, and anti-inflammatory effects that are induced by reduction of cytokines production through inhibition of neutrophil activation, and the analgesia may persist even after plasma concentration reduction. It can blunt the pressor response to endotracheal intubation also systemic lidocaine was effective in producing controlled hypotension.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for elective functional endoscopic sinus surgery;
• ASA class I-II,
• aged (20-60 years).

Exclusion criteria

• Body mass index >35 kg/m2
• History of allergic reaction to local anesthetic agents especially lignocaine.
• History of preoperative use of opioids.
• Patients with history of uncontrolled hypertension, A-V conduction block.
• History of sleep apnea.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Lidocaine group

Active Comparator group

Description:

patients will receive a loading dose of IV lidocaine 1.5mg/kg slowly diluted with 20 ml normal saline just before induction of anesthesia, then the lidocaine infusion started at a rate of 2mg/kg/h diluted in normal saline by rate of 2 ml/ kg/h.

Treatment:

Drug: Lidocaine

Control group

Placebo Comparator group

Description:

patients will receive an equal volume of normal saline (both the loading, and the infusion). The infusion in both groups will be started just after induction of anesthesia induction, and continued until the end of the operation.

Treatment:

Drug: Normal saline