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Completed

NCT Number: NCT02848365

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

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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Key information

Conditions

Pharyngitis Endotracheal Intubation Infections Neurologic Manifestations Otorhinolaryngologic Diseases Pain Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Saud University, King Khalid University Hospital

Riyadh, 11472, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endotracheal intubation

Device

Endotracheal intubation will be done with any of these equipments

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

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jul 28, 2016
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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