Nausea and Pain Prophylaxis During Thyroid Surgery

NCT00569920 | Completed DMC

• 2 other identifiers: s8197.04S-04189
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Diseases; Parathyroid Diseases

Outcome Measures

Primary Outcomes (1)

• Pain (VAS) and use of opioids. Nausea.

  30 days

Secondary Outcomes (1)

• Nausea

  30 days

Study Arms (3)

1

PLACEBO COMPARATOR

Placebo

Drug: natriumchloride 0,9%

2

ACTIVE COMPARATOR

dexamethasone "low-dose"

Drug: dexamethasone

3

ACTIVE COMPARATOR

Dexamethasone "high-dose"

Drug: dexamethasone

Interventions

dexamethasone DRUG

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).

Also known as: Fortecortin

2

natriumchloride 0,9% DRUG

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

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sykehuset Telemark: lead

Study Sites (1)

Surgery Unit, Porsgrunn, Acute Care Clinic, Telemark Hospital

Porsgrunn, Telemark, 3919, Norway

Location

MeSH Terms

Conditions

Thyroid Diseases; Parathyroid Diseases

Interventions

Dexamethasone; dexamethasone acetate

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Johan Raeder, Prof. M.D

  Ullevål university hospital, Oslo university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 7, 2007
• First Posted: December 10, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 15, 2009

Record last verified: 2009-01

Locations

NO (1)