NCT04623645

Brief Summary

The aim of this study is to evaluate the effect of ultrasound guided technique for block of internal branch of superior laryngeal nerve in surgical patient in comparison to blind anatomical technique.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

November 5, 2020

Last Update Submit

January 13, 2021

Conditions

Airway Complication of Anesthesia

Keywords

Suspected Difficult Intubation

Outcome Measures

Primary Outcomes (1)

  • assessment the quality of airway anesthesia

    The Quality of Airway anesthesia will be graded as: 0 = no coughing or gagging in response to intubation, 1 = mild coughing or gagging that will not hinder intubation, 2 = moderate coughing or gagging that will interfere minimally with intubation,3 = severe coughing or gagging that make intubation difficult and 4 = very severe coughing or gagging that will require additional local anesthetic or change in technique to achieve successful intubation.

    Up to 2 years post baseline

Study Arms (2)

ultrasound group

EXPERIMENTAL

patient using ultrasound technique.probe will be placed over submandibular area, the thyrohoid muscle and thyrohyoid membrane will be identified between greater horn fo hyoid bone and thyroid cartilage , 3 ml of lignocaine will be placed on space between thim and the procedure will repeated on contra lateral side.

Device: ultrasound technique

anatomical blind group

ACTIVE COMPARATOR

patient using anatomical land mark technique, internal branch of superior laryngeal nerve will be blocked slightly anterior to greater horn of hyoid bone . by 3 ml lignocaine . the procdure will be repeated on contra lateral side .

Device: ultrasound technique

Interventions

ultrasound techniqueDEVICE

evaluate the effect of ultrasound guided technique for block of internal branch of superior laryngeal nerve

anatomical blind groupultrasound group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists ( ASA ) physical status I and II.
  • Age between 40-60 years.
  • Modified Mallampati class III-IV .

You may not qualify if:

  • Local pathology of the neck.
  • Bleeding diathesis.
  • Allergy to local anesthetic agent.
  • Intellectual impairment.
  • Psychiatric disease.
  • Body mass index ≥30 kg/m2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alshaymaa Mortada Ali Eltohry

Alexandria, Please Select An Option, 21500, Egypt

RECRUITING

Related Publications (2)

  • Manikandan S, Neema PK, Rathod RC. Ultrasound-guided bilateral superior laryngeal nerve block to aid awake endotracheal intubation in a patient with cervical spine disease for emergency surgery. Anaesth Intensive Care. 2010 Sep;38(5):946-8. doi: 10.1177/0310057X1003800523.

    PMID: 20865885BACKGROUND

  • Ramkumar V. Preparation of the patient and the airway for awake intubation. Indian J Anaesth. 2011 Sep;55(5):442-7. doi: 10.4103/0019-5049.89863.

    PMID: 22174458BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Azza Mohamed Shafik, professor

    Ain shams university, faculty of medicine

    STUDY CHAIR

  • Abeer Mohamed Abdel-Aziz, professor

    Ain shams university, faculty of medicine

    STUDY DIRECTOR

Central Study Contacts

Alshaymaa Mortada Ali Eltohry, M.B.B.CH

CONTACT

+201006485550alshaymaaali62@gmail.com

sanaa Mohamed El Fawal, professor

CONTACT

+201143504178sana_y_fawal@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical researcher

Study Record Dates

First Submitted

November 5, 2020

First Posted

November 10, 2020

Study Start

February 1, 2021

Primary Completion

August 1, 2021

Study Completion

September 1, 2021

Last Updated

January 15, 2021

Record last verified: 2021-01

Locations

EG(1)