Post Operative Sore Throat and Dexamethasone

NCT01052038 | Completed Phase 4 Results

• 1 other identifier: STU00018901
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Sore Throat; Pain

Keywords

Sore throat; Dexamethasone; Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours

Secondary Outcomes (4)

• Quality of Recovery at 24 Hours

  24 hours

• Number of Subjects With Sore Throat at 3 Hours Post Surgery.

  3 hours.

• Opioid Consumption at 24 Hours

  24 hours

• Hoarseness at 24 Hours

  24 hours

Study Arms (3)

Group 1 Placebo

PLACEBO COMPARATOR

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

Drug: Placebo administration

Group 2: Dexamethasone 0.05mg/kg

ACTIVE COMPARATOR

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

Drug: Dexamethasone 0.05mg/kr administration

Group 3:Dexamethasone 0.1mg/kg

ACTIVE COMPARATOR

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

Drug: Dexamethasone 0.1mg/kg

Interventions

Placebo administration DRUG

Placebo administration

Also known as: Decadron, Corticosteroid

Group 1 Placebo

Dexamethasone 0.05mg/kr administration DRUG

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

Also known as: Decadron, corticosteroid

Group 2: Dexamethasone 0.05mg/kg

Dexamethasone 0.1mg/kg DRUG

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

Also known as: Decadron, corticosteroid

Group 3:Dexamethasone 0.1mg/kg

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients undergoing outpatient laparoscopic gynecologic surgery
• ASA PS I and II
• Age between 18 and 64 years
• Fluent in English

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwesten University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 21669954 RESULT

MeSH Terms

Conditions

Pharyngitis; Pain

Interventions

Calcium Dobesilate; Adrenal Cortex Hormones; Dexamethasone

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

Study was limited to 2 doses of dexamethasone and was underpowered to assess side effects such as hyperglycemia or delayed wound healing. Study was limited to a single type of surgery and results may differ in different types of surgery.

Results Point of Contact

• Title: Dr. Robert J. McCarthy
• Organization: Northwestern University Feinberg School of Medicine

r-mccarthy@northwestern.edu

312-926-9015

Study Officials

• Gildasio DeOliveira, M.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gildasio De Oliveira, M.D. Principal Investigator

Study Record Dates

• First Submitted: January 19, 2010
• First Posted: January 20, 2010
• Study Start: January 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 2, 2012
• Results First Posted: May 2, 2012

Record last verified: 2012-04

Locations

US (1)