Incidence and Severity of Postoperative Sore Throat And Intubation Response by Using Different Devices for Endotracheal Intubation

NCT ID: NCT02848365

Last Updated: 2019-02-27

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

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2016-08-31

Brief Summary

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Postoperative sore throat (POST) is a common problem following the use of endotracheal intubation during general anaesthesia. It leads to dissatisfaction and discomfort after surgery and can delay a patient's return to normal routine activities. POST has been rated by patients as the eighth most adverse effect in the postoperative period. The incidence of sore throat after endotracheal intubation varies from 14.4-90%. Laryngoscopy and tracheal intubation also leads to hemodynamic stress response. The response can be deleterious in patient with or without cardiac disease. It is related to the degree of manipulation of the airway during endotracheal intubation and has been studied during intubation for some equipment used for endotracheal intubation

Detailed Description

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Conditions

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Pharyngitis Endotracheal Intubation Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Glidescope

Group Type ACTIVE_COMPARATOR

Endotracheal intubation

Intervention Type DEVICE

Endotracheal intubation will be done with any of these equipments

Macintosh laryngoscope

Group Type ACTIVE_COMPARATOR

Endotracheal intubation

Intervention Type DEVICE

Endotracheal intubation will be done with any of these equipments

Bonfill's rigid scope

Group Type ACTIVE_COMPARATOR

Endotracheal intubation

Intervention Type DEVICE

Endotracheal intubation will be done with any of these equipments

Air traq

Group Type ACTIVE_COMPARATOR

Endotracheal intubation

Intervention Type DEVICE

Endotracheal intubation will be done with any of these equipments

C -Mac scope

Group Type ACTIVE_COMPARATOR

Endotracheal intubation

Intervention Type DEVICE

Endotracheal intubation will be done with any of these equipments

flexible fiberoptic scope

Group Type ACTIVE_COMPARATOR

Endotracheal intubation

Intervention Type DEVICE

Endotracheal intubation will be done with any of these equipments

Interventions

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Endotracheal intubation

Endotracheal intubation will be done with any of these equipments

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* After signing of the informed consent,
* ASA physical status I and II
* Mallampati class 1\& 2,
* BMI \< 35,
* Undergoing elective surgical procedures (not exceeding two hours in duration) requiring ET intubation

Exclusion Criteria

* Patients undergoing day case,
* bariatric, cardiac, nasal, oral or head \& neck surgeries,
* requiring placement of throat pack or nasogastric/ orogastric tube,
* patients assigned to rapid sequence induction,
* hoarseness,
* patients with anticipated difficult intubation,
* history of recent upper respiratory tract infection,
* history of difficult intubation
* psychiatric disorders hindering proper evaluation,
* use of steroids (oral or inhalational) or non-steroidal anti-inflammatory drugs within one week of surgery or previous surgery within last two weeks
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King Saud University

OTHER

Sponsor Role lead

Responsible Party

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Mansoor Aqil

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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King Saud University, King Khalid University Hospital

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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Aqil M, Khan MU, Mansoor S, Mansoor S, Khokhar RS, Narejo AS. Incidence and severity of postoperative sore throat: a randomized comparison of Glidescope with Macintosh laryngoscope. BMC Anesthesiol. 2017 Sep 12;17(1):127. doi: 10.1186/s12871-017-0421-4.

Reference Type DERIVED
PMID: 28899338 (View on PubMed)

Other Identifiers

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E-11-398

Identifier Type: -

Identifier Source: org_study_id

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