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Post Operative Sore Throat and Dexamethasone

Primary Purpose

Sore Throat, Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Placebo administration
Dexamethasone 0.05mg/kr administration
Dexamethasone 0.1mg/kg
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sore Throat focused on measuring Sore throat, Dexamethasone, Pain

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Northwesten University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Group 1 Placebo

Group 2: Dexamethasone 0.05mg/kg

Group 3:Dexamethasone 0.1mg/kg

Arm Description

Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.

Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery

Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.

Outcomes

Primary Outcome Measures

Subjects Assessment of Sore Throat Pain at 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.

Secondary Outcome Measures

Quality of Recovery at 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
Number of Subjects With Sore Throat at 3 Hours Post Surgery.
Subjects were asked at 3 hours post surgery if they were experiencing a sore throat.
Opioid Consumption at 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.
Hoarseness at 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.

Full Information

First Posted
January 19, 2010
Last Updated
April 5, 2012
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01052038
Brief Title
Post Operative Sore Throat and Dexamethasone
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore Throat, Pain
Keywords
Sore throat, Dexamethasone, Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
Arm Title
Group 2: Dexamethasone 0.05mg/kg
Arm Type
Active Comparator
Arm Description
Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
Arm Title
Group 3:Dexamethasone 0.1mg/kg
Arm Type
Active Comparator
Arm Description
Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
Intervention Type
Drug
Intervention Name(s)
Placebo administration
Other Intervention Name(s)
Decadron, Corticosteroid
Intervention Description
Placebo administration
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 0.05mg/kr administration
Other Intervention Name(s)
Decadron, corticosteroid
Intervention Description
Dexamethasone 0.05mg/kr administered in 100ml of sterile saline solution prior to the start of surgery.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 0.1mg/kg
Other Intervention Name(s)
Decadron, corticosteroid
Intervention Description
Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to the beginning of surgery.
Primary Outcome Measure Information:
Title
Subjects Assessment of Sore Throat Pain at 24 Hours
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Quality of Recovery at 24 Hours
Description
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
Time Frame
24 hours
Title
Number of Subjects With Sore Throat at 3 Hours Post Surgery.
Description
Subjects were asked at 3 hours post surgery if they were experiencing a sore throat.
Time Frame
3 hours.
Title
Opioid Consumption at 24 Hours
Description
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.
Time Frame
24 hours
Title
Hoarseness at 24 Hours
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gildasio DeOliveira, M.D.
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwesten University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21669954
Citation
De Oliveira GS Jr, Ahmad S, Fitzgerald PC, Marcus RJ, Altman CS, Panjwani AS, McCarthy RJ. Dose ranging study on the effect of preoperative dexamethasone on postoperative quality of recovery and opioid consumption after ambulatory gynaecological surgery. Br J Anaesth. 2011 Sep;107(3):362-71. doi: 10.1093/bja/aer156. Epub 2011 Jun 13.
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Post Operative Sore Throat and Dexamethasone

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