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Post Operative Sore Throat and Dexamethasone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier:
NCT01052038
First received: January 19, 2010
Last updated: April 5, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Sore Throat
Pain
Drug: Placebo administration
Drug: Dexamethasone 0.05mg/kr administration
Drug: Dexamethasone 0.1mg/kg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Subjects Assessment of Sore Throat Pain at 24 Hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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. [ Time Frame: 3 hours. ] [ Designated as safety issue: No ]
    Subjects were asked at 3 hours post surgery if they were experiencing a sore throat.

  • Opioid Consumption at 24 Hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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.


Enrollment: 120
Study Start Date: January 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052038

Locations
United States, Illinois
Northwesten University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Gildasio DeOliveira, M.D. Northwestern University
  More Information

Publications:
Responsible Party: Gildasio De Oliveira, Gildasio De Oliveira, M.D. Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01052038     History of Changes
Other Study ID Numbers: STU00018901
Study First Received: January 19, 2010
Results First Received: October 31, 2011
Last Updated: April 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Sore throat
Dexamethasone
Pain

Additional relevant MeSH terms:
Pharyngitis
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Stomatognathic Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014