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

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ClinicalTrials.gov Identifier: NCT02848365
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Mansoor Aqil, King Saud University

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

Condition or disease Intervention/treatment Phase
Pharyngitis Endotracheal Intubation Pain Device: Endotracheal intubation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Incidence and Severity of Postoperative Sore Throat And Intubation Response by Using Different Devices for Endotracheal Intubation
Study Start Date : June 2011
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Arm Intervention/treatment
Active Comparator: Glidescope Device: Endotracheal intubation
Endotracheal intubation will be done with any of these equipments

Active Comparator: Macintosh laryngoscope Device: Endotracheal intubation
Endotracheal intubation will be done with any of these equipments

Active Comparator: Bonfill's rigid scope Device: Endotracheal intubation
Endotracheal intubation will be done with any of these equipments

Active Comparator: Air traq Device: Endotracheal intubation
Endotracheal intubation will be done with any of these equipments

Active Comparator: C -Mac scope Device: Endotracheal intubation
Endotracheal intubation will be done with any of these equipments

Active Comparator: flexible fiberoptic scope Device: Endotracheal intubation
Endotracheal intubation will be done with any of these equipments




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848365


Locations
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Saudi Arabia
King Saud University, King Khalid University Hospital
Riyadh, Saudi Arabia, 11472
Sponsors and Collaborators
King Saud University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mansoor Aqil, Professor, King Saud University
ClinicalTrials.gov Identifier: NCT02848365     History of Changes
Other Study ID Numbers: E-11-398
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Keywords provided by Mansoor Aqil, King Saud University:
Measurement
Additional relevant MeSH terms:
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Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases