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CompletedNCT02848365Updated Feb 27, 2019

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

An interventional study of Endotracheal intubation in Pharyngitis, Endotracheal Intubation and Pain, sponsored by King Saud University. Completed at 1 site in Saudi Arabia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-27.

Sponsored by King Saud University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
420
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study 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

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Conditions studied

  • Pharyngitis
  • Endotracheal Intubation
  • Pain

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Keywords

  • Measurement
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In context

Pharyngitis

252 studies on the registry are indexed under Pharyngitis; 36 are open to participants now.

This study's enrollment of 420 is above the median of 144 across 209 interventional studies indexed under Pharyngitis.

Browse Pharyngitis studies →

Lead sponsor

King Saud University is the lead sponsor of 164 studies on the registry; 21 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
420 participants (actual)

Study arms

  • Active comparator
    Glidescope

    Device: Endotracheal intubation

  • Active comparator
    Macintosh laryngoscope

    Device: Endotracheal intubation

  • Active comparator
    Bonfill's rigid scope

    Device: Endotracheal intubation

  • Active comparator
    Air traq

    Device: Endotracheal intubation

  • Active comparator
    C -Mac scope

    Device: Endotracheal intubation

  • Active comparator
    flexible fiberoptic scope

    Device: Endotracheal intubation

Interventions

  • DeviceEndotracheal intubation

    Endotracheal intubation will be done with any of these equipments

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What researchers measure

Primary outcomes

  1. Incidence of post operative sore throat

    Time frame: 0 hours after surgery

  2. Incidence of post operative sore throat

    Time frame: 6 hours after surgery

  3. Incidence of post operative sore throat

    Time frame: 12 hours after surgery

  4. Incidence of post operative sore throat

    Time frame: 24 hours after surgery

  5. Severity of post operative sore throat

    Time frame: 0 hours after surgery

  6. Severity of post operative sore throat

    Time frame: 6 hours after surgery

  7. Severity of post operative sore throat

    Time frame: 12 hours after surgery

  8. Severity of post operative sore throat

    Time frame: 24 hours after surgery

  9. Mean arterial pressure after endotracheal intubation

    Time frame: 1 minute after surgery

  10. Mean arterial pressure after endotracheal intubation

    Time frame: 2 minutes after surgery

  11. Mean arterial pressure after endotracheal intubation

    Time frame: 3 minutes after surgery

  12. Mean arterial pressure after endotracheal intubation

    Time frame: 4 minutes after surgery

  13. Mean arterial pressure after endotracheal intubation

    Time frame: 5 minutes after surgery

Secondary outcomes

  1. cormack Leehanes grade of laryngeal view

    Time frame: At the time of intubation

  2. Percentage of glottic opening score (POGO) score

    Time frame: At the time of intubation

  3. Intubation difficulty score

    Time frame: At the time of intubation

  4. Patient's satisfaction score

    Time frame: After 24 hours of surgery

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Study locations

1 site
  • King Saud University, King Khalid University Hospital
    Riyadh, 11472, Saudi Arabia
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References and documents

Publications

  • 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. Erratum In: BMC Anesthesiol. 2018 Aug 17;18(1):112. doi: 10.1186/s12871-018-0575-8. PubMed 28899338 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2019, 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
NCT02848365
Lead sponsor
King Saud University
Responsible party
Mansoor Aqil (Professor, King Saud University) — Principal investigator
First posted
Jul 28, 2016
Start date
Jun 2011
Primary completion
Aug 2016
Completion
Aug 2016
Last update
Feb 27, 2019
View the source record on ClinicalTrials.gov ↗

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