Study Results
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Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2007-09-30
2008-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
Placebo
natriumchloride 0,9%
iv natriumchloride 0,9% (placebo). 1 mL is equivalent to 10 kg body weight.
2
dexamethasone "low-dose"
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).
3
Dexamethasone "high-dose"
dexamethasone
IV dexamethasone 0,30 mg/kg body weight. Drug diluted to 3,0 mg/mL and administrated in same way as arm 2.
Interventions
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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).
natriumchloride 0,9%
iv natriumchloride 0,9% (placebo). 1 mL is equivalent to 10 kg body weight.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent
Exclusion Criteria
* Patients who use antiemetics
* Patients who use opioid analgesics
* Body weight \> 100 kg
* BMI \> 35
18 Years
70 Years
ALL
No
Sponsors
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Sykehuset Telemark
OTHER_GOV
Responsible Party
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Sykehuset Telemark
Principal Investigators
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Johan Raeder, Prof. M.D
Role: STUDY_DIRECTOR
Ullevål university hospital, Oslo university
Locations
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Surgery Unit, Porsgrunn, Acute Care Clinic, Telemark Hospital
Porsgrunn, Telemark, Norway
Countries
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Other Identifiers
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S-04189
Identifier Type: -
Identifier Source: secondary_id
s8197.04
Identifier Type: -
Identifier Source: org_study_id
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