Post Operative Sore Throat and Dexamethasone
|ClinicalTrials.gov Identifier: NCT01052038|
Recruitment Status : Completed
First Posted : January 20, 2010
Results First Posted : May 2, 2012
Last Update Posted : May 2, 2012
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 or disease||Intervention/treatment||Phase|
|Sore Throat Pain||Drug: Placebo administration Drug: Dexamethasone 0.05mg/kr administration Drug: Dexamethasone 0.1mg/kg||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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 Start Date :||January 2010|
|Primary Completion Date :||September 2010|
|Study Completion Date :||September 2010|
Placebo Comparator: Group 1 Placebo
Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
Drug: Placebo administration
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.
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.
- 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.
- 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
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01052038
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Gildasio DeOliveira, M.D.||Northwestern University|