Nausea and Pain Prophylaxis During Thyroid Surgery

Sponsor

Sykehuset Telemark (Other)

Overall Status

Completed

CT.gov ID

NCT00569920

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Postoperative pain and nausea may diminish a patient's wellbeing, and may also delay rehabilitation, as well as increase the total cost of care and treatment. Opioids are effective drugs for treatment of pain, but with the disadvantage of side effects such as somnolence and nausea. The benefits of various types of non-opioid analgesic in reducing patients' postoperative need for opioids have been well-documented.

One non-opioid prophylaxis documented for various surgery is short-term treatment with corticosteroids. The optimal dose of corticosteroids for peroperative nausea and pain prophylaxis is not well-documented. In our study we will attempt to determine whether the aforementioned benefits of corticosteroids are valid for a group of patients undergoing thyroid surgery.

Hypothesis: Single-dose treatment with dexamethasone provides a better analgesic effect and/or reduced use of opioids than placebo in patients undergoing elective throid surgery. Higher dose of dexamethasone provide better and/or longer-lasting analgesic effects without influencing the side effect profile.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Diseases Parathyroid Diseases	Drug: dexamethasone Drug: natriumchloride 0,9% Drug: dexamethasone	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Nausea and Pain Prophylaxis During Thyroid Surgery, a Comparison of Low-Dose and High-Dose Dexamethasone to Placebo

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1 Placebo	Drug: natriumchloride 0,9% iv natriumchloride 0,9% (placebo). 1 mL is equivalent to 10 kg body weight.
Active Comparator: 2 dexamethasone "low-dose"	Drug: dexamethasone IV dexamethasone 0,15 mg/kg bodyweight. Single-dose bolus injection after start of anesthesia. Medication is opened and administrated to the patient from a coded ampoule by the physician. The medication is diluted in such a way that 1 mL is equivalent to 10 kg body weight (1,5 mg/mL). Other Names: Fortecortin
Active Comparator: 3 Dexamethasone "high-dose"	Drug: dexamethasone IV dexamethasone 0,30 mg/kg body weight. Drug diluted to 3,0 mg/mL and administrated in same way as arm 2. Other Names: fortecortin

Arm

Intervention/Treatment

Placebo Comparator: 1

Placebo

Drug: natriumchloride 0,9%

iv natriumchloride 0,9% (placebo). 1 mL is equivalent to 10 kg body weight.

Active Comparator: 2

dexamethasone "low-dose"

Drug: dexamethasone

IV dexamethasone 0,15 mg/kg bodyweight. Single-dose bolus injection after start of anesthesia. Medication is opened and administrated to the patient from a coded ampoule by the physician. The medication is diluted in such a way that 1 mL is equivalent to 10 kg body weight (1,5 mg/mL).

Other Names:

Fortecortin

Active Comparator: 3

Dexamethasone "high-dose"

Drug: dexamethasone

IV dexamethasone 0,30 mg/kg body weight. Drug diluted to 3,0 mg/mL and administrated in same way as arm 2.

Other Names:

fortecortin

Outcome Measures

Primary Outcome Measures

Pain (VAS) and use of opioids. Nausea. [30 days]

Secondary Outcome Measures

Nausea [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Inpatients scheduled for elective thyroid surgery and parathyroid surgery under general anesthesia.
Informed consent

Exclusion Criteria:

Patients who use steroids
Patients who use antiemetics
Patients who use opioid analgesics
Body weight > 100 kg
BMI > 35

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Surgery Unit, Porsgrunn, Acute Care Clinic, Telemark Hospital	Porsgrunn	Telemark	Norway	3919

Sponsors and Collaborators

Sykehuset Telemark

Investigators

Study Director: Johan Raeder, Prof. M.D, Ullevål university hospital, Oslo university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00569920

Other Study ID Numbers:

s8197.04
S-04189

First Posted:

Dec 10, 2007

Last Update Posted:

Jan 15, 2009

Last Verified:

Jan 1, 2009

Additional relevant MeSH terms:

Thyroid Diseases

Parathyroid Diseases

Dexamethasone

Dexamethasone acetate

BB 1101

Study Results

No Results Posted as of Jan 15, 2009