Post Operative Sore Throat and Dexamethasone
Information source: Northwestern University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sore Throat; Pain
Intervention: Placebo administration (Drug); Dexamethasone 0.05mg/kr administration (Drug); Dexamethasone 0.1mg/kg (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Northwestern University Official(s) and/or principal investigator(s): Gildasio DeOliveira, M.D., Principal Investigator, Affiliation: Northwestern University
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Subjects Assessment of Sore Throat Pain at 24 Hours
Secondary outcome: Quality of Recovery at 24 HoursNumber of Subjects With Sore Throat at 3 Hours Post Surgery. Opioid Consumption at 24 Hours Hoarseness at 24 Hours
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
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Female.
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
Locations and Contacts
Northwesten University, Chicago, Illinois 60611, United States
Additional Information
Starting date: January 2010
Last updated: April 5, 2012
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