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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02848365
Enrollment
420
Registered
2016-07-28
Start date
2011-06-30
Completion date
2016-08-31
Last updated
2019-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotracheal Intubation, Pain, Pharyngitis

Keywords

Measurement

Brief summary

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

Interventions

DEVICEEndotracheal intubation

Endotracheal intubation will be done with any of these equipments

Sponsors

King Saud University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Incidence of post operative sore throat0 hours after surgery
Severity of post operative sore throat0 hours after surgery
Mean arterial pressure after endotracheal intubation1 minute after surgery

Secondary

MeasureTime frame
cormack Leehanes grade of laryngeal viewAt the time of intubation
Patient's satisfaction scoreAfter 24 hours of surgery
Percentage of glottic opening score (POGO) scoreAt the time of intubation
Intubation difficulty scoreAt the time of intubation

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026