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

Study Overview

• Status: Completed
• Conditions: Pain; Endotracheal Intubation; Pharyngitis
• Intervention / Treatment: Device: Endotracheal intubation

• Study Type: Interventional
• Enrollment (Actual): 420
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11472
    • King Saud University, King Khalid University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of post operative sore throat	0 hours after surgery
Incidence of post operative sore throat	6 hours after surgery
Incidence of post operative sore throat	12 hours after surgery
Incidence of post operative sore throat	24 hours after surgery
Severity of post operative sore throat	0 hours after surgery
Severity of post operative sore throat	6 hours after surgery
Severity of post operative sore throat	12 hours after surgery
Severity of post operative sore throat	24 hours after surgery
Mean arterial pressure after endotracheal intubation	1 minute after surgery
Mean arterial pressure after endotracheal intubation	2 minutes after surgery
Mean arterial pressure after endotracheal intubation	3 minutes after surgery
Mean arterial pressure after endotracheal intubation	4 minutes after surgery
Mean arterial pressure after endotracheal intubation	5 minutes after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
cormack Leehanes grade of laryngeal view	At the time of intubation
Percentage of glottic opening score (POGO) score	At the time of intubation
Intubation difficulty score	At the time of intubation
Patient's satisfaction score	After 24 hours of surgery

Collaborators and Investigators

• Sponsor: King Saud University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: July 22, 2016
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (Estimate): July 28, 2016

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Measurement
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis
• Other Study ID Numbers: E-11-398