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Status unknownNCT04472689Updated Aug 18, 2020

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

An interventional study of Lidocaine and Normal saline in Chronic Polypous Rhinosinusitis, sponsored by Alexandria University. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-08-18.

Sponsored by Alexandria University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Chronic Polypous Rhinosinusitis

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03

In context

Rhinosinusitis

330 studies on the registry are indexed under Rhinosinusitis; 55 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 227 interventional studies indexed under Rhinosinusitis.

Browse Rhinosinusitis studies →

Lead sponsor

Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Lidocaine group

    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

  • Placebo comparator
    Control group

    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

  • 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

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What researchers measure

Primary outcomes

  1. quality of postoperative recovery

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

    Time frame: 48hours

  2. Emergence agitation

    using the Richmond agitation-sedation scale

    Time frame: 30 minutes postoperative

07

Study locations

1 of 1 sites recruiting
  • Rehab Abd Elraof Abd Elaziz
    Alexandria, 000000, Egypt
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04472689
Lead sponsor
Alexandria University
Responsible party
rehab zayed (Assisstant Professor of Anesthesia, Alexandria University) — Principal investigator
First posted
Jul 15, 2020
Start date
Jul 1, 2020
Primary completion
Sep 20, 2020 (estimated)
Completion
Oct 20, 2020 (estimated)
Last update
Aug 18, 2020

Study contacts

Rehab A. Abd Elaziz, Ass. Prof.
Contact
trcium2002@yahoo.com
01001073703 ext. 020
Rehab A. Abd Elaziz, Ass.Prof.
principal investigator · Alexandria University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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