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

Chronic Polypous Rhinosinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04472689
• Other study ID #: 0304701
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: October 20, 2020

Study information

• Verified date: August 2020
• Source: Alexandria University
• Contact: Rehab A. Abd Elaziz, Ass. Prof.
• Phone: 01001073703
• Email: trcium2002[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 20, 2020
• Est. primary completion date: September 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Polypous Rhinosinusitis
• Psychomotor Agitation

Intervention

Drug:
• 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.
• 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

Locations

Country	Name	City	State
Egypt	Rehab Abd Elraof Abd Elaziz	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of postoperative recovery	assessed using the Quality of Recovery-40 questionnaire.8, which assesses ?ve dimensions of recovery	48hours
Primary	Emergence agitation	using the Richmond agitation-sedation scale	30 minutes postoperative