CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 120 enrolled
Drug / intervention
Placebo administration +2 moredrug
Likely dose
Dexamethasone 0.05mg/kr administrationfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01052038
NCT01052038Phase 4Completed

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

Northwestern University·interventional·Posted Jan 20, 2010·Updated May 2, 2012

In Brief

A Phase 4 clinical trial evaluating Placebo administration, Dexamethasone 0.05mg/kr administration, and 1 other intervention for Sore Throat and Pain. Completed, enrolled 120 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSore Throat, Pain
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 20, 2010
Enrollment StartJan 1, 2010
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 16.4 years ago

Interventions

Placebo administrationdrug

Placebo administration

Dexamethasone 0.05mg/kr administrationdrug

Dexamethasone 0.05mg/kr administered in 100ml of sterile saline solution prior to the start of surgery.

Dexamethasone 0.1mg/kgdrug

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