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

NCT02848365 | Completed

• 1 other identifier: E-11-398
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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

Conditions

Pharyngitis; Endotracheal Intubation; Pain

Keywords

Measurement

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (4)

• 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

Study Arms (6)

Glidescope

ACTIVE COMPARATOR

Device: Endotracheal intubation

Macintosh laryngoscope

ACTIVE COMPARATOR

Device: Endotracheal intubation

Bonfill's rigid scope

ACTIVE COMPARATOR

Device: Endotracheal intubation

Air traq

ACTIVE COMPARATOR

Device: Endotracheal intubation

C -Mac scope

ACTIVE COMPARATOR

Device: Endotracheal intubation

flexible fiberoptic scope

ACTIVE COMPARATOR

Device: Endotracheal intubation

Interventions

Endotracheal intubation DEVICE

Endotracheal intubation will be done with any of these equipments

Air traq; Bonfill's rigid scope; C -Mac scope; Glidescope; Macintosh laryngoscope; flexible fiberoptic scope

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

King Saud University, King Khalid University Hospital

Riyadh, 11472, Saudi Arabia

Location

Related Publications (1)

• 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.

  PMID: 28899338 DERIVED

MeSH Terms

Conditions

Pharyngitis; Pain

Interventions

Intubation, Intratracheal

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: July 28, 2016
• Study Start: June 1, 2011
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

SA (1)