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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02848365
• Other study ID #: E-11-398
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: August 2016

Study information

• Verified date: February 2019
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Endotracheal Intubation
• Pain
• Pharyngitis

Intervention

Device:
• Endotracheal intubation
Endotracheal intubation will be done with any of these equipments

Locations

Country	Name	City	State
Saudi Arabia	King Saud University, King Khalid University Hospital	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of post operative sore throat		0 hours after surgery
Primary	Incidence of post operative sore throat		6 hours after surgery
Primary	Incidence of post operative sore throat		12 hours after surgery
Primary	Incidence of post operative sore throat		24 hours after surgery
Primary	Severity of post operative sore throat		0 hours after surgery
Primary	Severity of post operative sore throat		6 hours after surgery
Primary	Severity of post operative sore throat		12 hours after surgery
Primary	Severity of post operative sore throat		24 hours after surgery
Primary	Mean arterial pressure after endotracheal intubation		1 minute after surgery
Primary	Mean arterial pressure after endotracheal intubation		2 minutes after surgery
Primary	Mean arterial pressure after endotracheal intubation		3 minutes after surgery
Primary	Mean arterial pressure after endotracheal intubation		4 minutes after surgery
Primary	Mean arterial pressure after endotracheal intubation		5 minutes after surgery
Secondary	cormack Leehanes grade of laryngeal view		At the time of intubation
Secondary	Percentage of glottic opening score (POGO) score		At the time of intubation
Secondary	Intubation difficulty score		At the time of intubation
Secondary	Patient's satisfaction score		After 24 hours of surgery