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

Effects of Lidocaine Infusion on Quality of Recovery and Agitation After Functional Endoscopic Sinus Surgery: Randomized Controlled Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04472689
Enrollment
60
Registered
2020-07-15
Start date
2020-07-01
Completion date
2020-10-20
Last updated
2020-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Polypous Rhinosinusitis

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.

Interventions

DRUGLidocaine

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.

DRUGNormal 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

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
quality of postoperative recovery48hoursassessed using the Quality of Recovery-40 questionnaire.8, which assesses five dimensions of recovery
Emergence agitation30 minutes postoperativeusing the Richmond agitation-sedation scale

Countries

Egypt

Contacts

Primary ContactRehab A. Abd Elaziz, Ass. Prof.
trcium2002@yahoo.com01001073703

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026