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

Not Applicable

• Conditions: Chronic Polypous Rhinosinusitis
• Interventions: Drug: Normal saline; Drug: Lidocaine

• Registration Number: NCT04472689
• Lead Sponsor: Alexandria University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-07-11
• Study First Submitted QC: 2020-07-11
• Study First Posted: 2020-07-15
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-16
• Last Update Posted: 2020-08-18
• Primary Completion: 2020-09-20
• Study Completion: 2020-10-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Normal saline	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.
Lidocaine group	Lidocaine	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.

Primary Outcome Measures

Name	Time	Method
quality of postoperative recovery	48hours	assessed using the Quality of Recovery-40 questionnaire.8, which assesses five dimensions of recovery
Emergence agitation	30 minutes postoperative	using the Richmond agitation-sedation scale

Trial Locations

Locations (1)

Rehab Abd Elraof Abd Elaziz; 🇪🇬 Alexandria, Egypt