Clinical trial NCT02848365: Incidence and Severity of Postoperative Sore Throat And Intubation Response by Using Different Devices for Endotracheal Intubation
Official title: Incidence and Severity of Postoperative Sore Throat And Intubation Response by Using Different Devices for Endotracheal Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharyngitis
Endotracheal Intubation
Pain
Keywords: Measurement
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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


Eligibility 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

Primary outcomes:
measure: Incidence of post operative sore throat
timeFrame: 0 hours after surgery
measure: Incidence of post operative sore throat
timeFrame: 6 hours after surgery
measure: Incidence of post operative sore throat
timeFrame: 12 hours after surgery
measure: Incidence of post operative sore throat
timeFrame: 24 hours after surgery
measure: Severity of post operative sore throat
timeFrame: 0 hours after surgery
measure: Severity of post operative sore throat
timeFrame: 6 hours after surgery
measure: Severity of post operative sore throat
timeFrame: 12 hours after surgery
measure: Severity of post operative sore throat
timeFrame: 24 hours after surgery
measure: Mean arterial pressure after endotracheal intubation
timeFrame: 1 minute after surgery
measure: Mean arterial pressure after endotracheal intubation
timeFrame: 2 minutes after surgery
measure: Mean arterial pressure after endotracheal intubation
timeFrame: 3 minutes after surgery
measure: Mean arterial pressure after endotracheal intubation
timeFrame: 4 minutes after surgery
measure: Mean arterial pressure after endotracheal intubation
timeFrame: 5 minutes after surgery
Secondary outcomes:
measure: cormack Leehanes grade of laryngeal view
timeFrame: At the time of intubation
measure: Percentage of glottic opening score (POGO) score
timeFrame: At the time of intubation
measure: Intubation difficulty score
timeFrame: At the time of intubation
measure: Patient's satisfaction score
timeFrame: After 24 hours of surgery
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University, King Khalid University Hospital
Study officials:
References:
citation: 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.