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

Primary Purpose

Chronic Polypous Rhinosinusitis

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Lidocaine
Normal saline
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Polypous Rhinosinusitis

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Rehab Abd Elraof Abd ElazizRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lidocaine group

Control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

quality of postoperative recovery
assessed using the Quality of Recovery-40 questionnaire.8, which assesses five dimensions of recovery
Emergence agitation
using the Richmond agitation-sedation scale

Secondary Outcome Measures

Full Information

First Posted
July 11, 2020
Last Updated
August 16, 2020
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04472689
Brief Title
Effects of Lidocaine Infusion on Quality of Recovery and Agitation After Functional Endoscopic Sinus Surgery
Official Title
Effects of Lidocaine Infusion on Quality of Recovery and Agitation After Functional Endoscopic Sinus Surgery: Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
September 20, 2020 (Anticipated)
Study Completion Date
October 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Polypous Rhinosinusitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine group
Arm Type
Active Comparator
Arm 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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention 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
Primary Outcome Measure Information:
Title
quality of postoperative recovery
Description
assessed using the Quality of Recovery-40 questionnaire.8, which assesses five dimensions of recovery
Time Frame
48hours
Title
Emergence agitation
Description
using the Richmond agitation-sedation scale
Time Frame
30 minutes postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rehab A. Abd Elaziz, Ass. Prof.
Phone
01001073703
Ext
020
Email
trcium2002@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rehab A. Abd Elaziz, Ass.Prof.
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehab Abd Elraof Abd Elaziz
City
Alexandria
ZIP/Postal Code
000000
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rehab A. Abd Elaziz, Ass. Prof.
Phone
01001073703
Ext
020
Email
trcium2002@yahoo.com

12. IPD Sharing Statement

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

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