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Efficacy of External Nasal Nerve Block in Prevention of Postoperative Agitation Following Nasal Surgeries

NCT ID: NCT03069027

Last Updated: 2017-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-15

Study Completion Date

2017-07-01

Brief Summary

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Emergence agitation following general anaesthesia may lead to serious complications like self-extubation or removal of catheters, which can lead to hypoxia, aspiration pneumonia, bleeding or reoperation. Nose surgery is associated with a higher incidence of emergence agitation. The investigators planned to evaluate the efficacy of external nasal nerve block in prevention of postoperative agitation following external nasal surgeries under general anesthesia(GA).

Detailed Description

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Conditions

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Agitation States as Acute Reaction to Gross Stress

Keywords

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Nasal surgery external nasal nerve block postoperative agitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Group I(control)

patients allocated for external nasal nerve block with saline adrenaline 1/200,000 (placebo)

Group Type PLACEBO_COMPARATOR

External nasal nerve block

Intervention Type PROCEDURE

Three single (midline injection) and 4 paired (bilateral injection) sites to block the external nasal sensation.

saline adrenaline

Intervention Type DRUG

Group II(block)

'External nasal nerve block by Xylocaine, adrenaline'

Group Type ACTIVE_COMPARATOR

External nasal nerve block

Intervention Type PROCEDURE

Three single (midline injection) and 4 paired (bilateral injection) sites to block the external nasal sensation.

Xylocaine, adrenaline

Intervention Type DRUG

Interventions

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External nasal nerve block

Three single (midline injection) and 4 paired (bilateral injection) sites to block the external nasal sensation.

Intervention Type PROCEDURE

saline adrenaline

Intervention Type DRUG

Xylocaine, adrenaline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 110 adult patients of ASA physical status I and II,
* Age 20-60 years,
* Scheduled for elective external nasal surgeries in which nasal packing on each side was used postoperatively for 24 hours.

Exclusion Criteria

1. History of uncontrolled hypertension,
2. Ischemic or valvular heart disease,
3. Use of MAO inhibitors or adrenergic blocking drugs,
4. Cognitive impairment,
5. Patients taking antipsychotics,
6. Renal insufficiency or liver dysfunction
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al Jedaani Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Mohamed Ibrahim

Assistant Professor of Anesthesiology- Zagazig University - Consultant of anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al Jedaani group of hospitals

Jeddah, Meccah, Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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3-2-17

Identifier Type: -

Identifier Source: org_study_id