Post Operative Sore Throat and Dexamethasone

April 5, 2012 updated by: Gildasio De Oliveira, Northwestern University

The Effect of Systemic Prophylactic Dexamethasone on the Incidence of Postoperative Sore Throat in Patients Undergoing Ambulatory Laparoscopic Gynecologic Surgery: A Prospective, Randomized, Double Blinded, Placebo Controlled Trial

Sore throat is a common postoperative complaint that can lead to morbidity and patient dissatisfaction . The incidence of sore throat has been reported to be between 6% and 90% even under optimal intubating conditions. There are several factors that have been shown to contribute to postoperative sore throat such as patient related factors, type of anesthesia and type of surgery.

Corticosteroids are also commonly used in the perioperative period to potentiate analgesics and as antiemetics. The preoperative administration of dexamethasone can decrease the incidence and severity of postoperative sore throat which is rated by patients as one of the most undesirable outcomes in the postoperative period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sore throat is a common postoperative complaint that can lead to morbidity and patient dissatisfaction. The incidence of sore throat has been reported to be between 6% and 90% even under optimal intubating conditions. There are several factors that have been shown to contribute to postoperative sore throat such as patient related factors, type of anesthesia and type of surgery. It has been observed that gargle with azunol reduced the incidence of postoperative sore throat from 65% to 25 %. Similarly, a reduction in sore throat following tracheal intubation from 78% to 40 % has been reported after gargle with ketamine performed 5 minutes before induction of anesthesia. More recently, it was also demonstrated that preoperative gargle with licorice resulted in a 57 percent reduction of the absolute risk of sore throat after intubation. Although the gargling technique has been shown to be successful in decreasing the incidence of postoperative sore throat, it has a limited feasibility because the volumes administered could increase the chance of aspiration if ingested and it may be difficult to perform in sedated patients and in children.

Tracheal intubation is associated with an increase of polymorphonuclear cells in the tracheal tissue and plasma levels of interleukin 6, suggesting an inflammatory response to the presence of the endotracheal tube itself or to some aspect of the intubation process. Dexamethasone is widely prescribed for the treatment of a sore throat resulting from tracheal mechanical irritation due to its modulating effects of tissue edema and pain. Moreover, prophylactic dexamethasone has been shown to be effective in reducing the frequency of airway obstruction in patients at high risk for laryngeal edema following extubation. It decreases postoperative sore throat in patients requiring double-lumen tubes.

Dexamethasone has been shown to decrease postoperative sore throat in patients requiring hospital admission but it has not been evaluated in the ambulatory setting. Ambulatory patients usually need to return to work faster than patients who are admitted to the hospital. Their ability to tolerate fluids and food might help them to return to normal living. They also have smaller surgeries which might increased their perception to sore throat pain when compared to bigger, more painful procedures.

Possible side effects of corticosteroids such as retardation of wound healing, susceptibility to infection and gastrointestinal hemorrhage have not been noted with short term use (<24 hours ) in surgical patients. Corticosteroids are also commonly used in the perioperative period to potentiate analgesics and as antiemetics.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwesten University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female patients undergoing outpatient laparoscopic gynecologic surgery
  • ASA PS I and II
  • Age between 18 and 64 years
  • Fluent in English

Exclusion Criteria:

  • History of recent respiratory tract infection
  • Pregnancy, breastfeeding
  • Current treatment with analgesics
  • Current use of corticosteroids
  • Anticipated difficult intubation
  • Risk factors for post-operative aspiration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Group 1 Placebo
Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
Drug: Placebo administration
Placebo administration
Other Names:
  • Decadron
  • Corticosteroid
ACTIVE_COMPARATOR: Group 2: Dexamethasone 0.05mg/kg
Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
Drug: Dexamethasone 0.05mg/kr administration
Dexamethasone 0.05mg/kr administered in 100ml of sterile saline solution prior to the start of surgery.
Other Names:
  • Decadron
  • corticosteroid
ACTIVE_COMPARATOR: Group 3:Dexamethasone 0.1mg/kg
Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
Drug: Dexamethasone 0.1mg/kg
Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to the beginning of surgery.
Other Names:
  • Decadron
  • corticosteroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjects Assessment of Sore Throat Pain at 24 Hours
Time Frame: 24 hours
The reported score for sore throat on a 1 to 5 scale where 1 is a severe sore throat and 5 is no sore throat. This evaluation was made by investigator initiated phone conversation at 24 hours following surgery.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Recovery at 24 Hours
Time Frame: 24 hours
The quality of recovery (QoR-40) questionnaire assess the subjects perceived quality of recovery following surgery. The tool assess pain, physical and psychological well being as well as ability to ability for self-care. Questions are scored on a 1 to 5 point scale with a higher value indication a better outcome. The scores or the individual questions are summed to obtain a total score. The minimum total score is 30 and the maximum is 200. The higher the score the better the recovery
24 hours
Number of Subjects With Sore Throat at 3 Hours Post Surgery.
Time Frame: 3 hours.
Subjects were asked at 3 hours post surgery if they were experiencing a sore throat.
3 hours.
Opioid Consumption at 24 Hours
Time Frame: 24 hours
The cumulative use of an opioid analgesic pain medication taken during the first 24 hours for pain and discomfort. Data reported as equivalent dose of oral morphine.
24 hours
Hoarseness at 24 Hours
Time Frame: 24 hours
Self assessment of the degree of hoarseness 24 hours after surgery and intratracheal intubation on a 1 to 1 Likert scale. 0 = no hoarseness and 3= hoarseness easily noted at time of interview.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Gildasio DeOliveira, M.D., Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

September 1, 2010

Study Completion (ACTUAL)

September 1, 2010

Study Registration Dates

First Submitted

January 19, 2010

First Submitted That Met QC Criteria

January 19, 2010

First Posted (ESTIMATE)

January 20, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 2, 2012

Last Update Submitted That Met QC Criteria

April 5, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00018901

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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