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

NCT04472689 | Unknown

• 1 other identifier: 0304701
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Polypous Rhinosinusitis

Outcome Measures

Primary Outcomes (2)

• quality of postoperative recovery

  assessed using the Quality of Recovery-40 questionnaire.8, which assesses five dimensions of recovery

  48hours

• Emergence agitation

  using the Richmond agitation-sedation scale

  30 minutes postoperative

Study Arms (2)

Lidocaine group

ACTIVE COMPARATOR

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.

Drug: Lidocaine

Control group

PLACEBO COMPARATOR

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.

Drug: Normal saline

Interventions

Lidocaine DRUG

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.

Lidocaine group

Normal saline DRUG

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

Control group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Rehab Abd Elraof Abd Elaziz

Alexandria, 000000, Egypt

RECRUITING

MeSH Terms

Interventions

Lidocaine; Saline Solution

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Rehab A. Abd Elaziz, Ass.Prof.

  Alexandria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rehab A. Abd Elaziz, Ass. Prof.

CONTACT

01001073703; trcium2002@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor of Anesthesia

Study Record Dates

• First Submitted: July 11, 2020
• First Posted: July 15, 2020
• Study Start: July 1, 2020
• Primary Completion: September 20, 2020
• Study Completion: October 20, 2020
• Last Updated: August 18, 2020

Record last verified: 2020-08

Locations

EG (1)