Steroid Before Thyroidectomy

• Sponsor: University of Bern (Other)
• Overall Status: Completed
• CT.gov ID: NCT00619086
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 2
• Duration (Months): 19
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

We evaluated the effects of giving a single dose of steroid before thyroid surgery in a single institutional, double-blinded, randomized controlled trial. Postoperative nausea, pain, and vocal function were significantly improved after steroid administration compared to controls.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Surgery for Benign Disease	Drug: Dexamethason Helvepharm ®; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Official Title: Does a Single Dose of Steroid Before Thyroidectomy Improve Postoperative Nausea, Pain and Vocal Function?
• Study Start Date: Nov 1, 2005
• Actual Study Completion Date: Jun 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: A, 1 Placebo 45 minutes prior to surgery	Drug: Placebo; 100 ml sodium chloride i.v. 45 minutes prior to surgery
Active Comparator: A, 2 8 mg Dexamethasone 45 minutes prior to surgery	Drug: Dexamethason Helvepharm ®; 8 mg Dexamethason i.v. 45 minutes prior to surgery

Outcome Measures

Primary Outcome Measures

1. Nausea [0-72 hours postoperative]

Secondary Outcome Measures

1. Pain, vocal function [0-72 hours postoperative]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients undergoing thyroid surgery for benign disease

Exclusion Criteria:

• Depression

• Chronic pain disorder

• Insulin dependent diabetes mellitus

• History of PONV

• Pregnancy

• Age < 18 years

• Received antiemetic therapy within 48 hours

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of visceral- and transplant surgery	Bern		Switzerland	3010

Sponsors and Collaborators

• University of Bern

Investigators

• Principal Investigator: Stephan A. Vorburger, MD, Dept of visceral- and transplant surgery, University Hospital Bern

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00619086
• Other Study ID Numbers: KEK_49_05
• First Posted: Feb 20, 2008
• Last Update Posted: Jun 9, 2008
• Last Verified: Jun 1, 2008

• Keywords provided by , ,: thyroidectomy; dexamethasone; steroid; nausea

Study Results

No Results Posted as of Jun 9, 2008