Effect of Combination Dexmedetomidine Added to Fentanyl-based Intravenous Patient-controlled Analgesia on Nausea Vomiting in Highly Susceptible Patients Undergoing Lumbar Spinal Surgery: Prospective Double Blinded Randomized Controlled Trial

Yonsei University

Status: Completed

Conditions: PONV

Treatments: Drug: normal saline; Drug: dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01840254

4-2012-0490

Details and patient eligibility

About

The aim of this study is to test the hypothesis that addition of dexmedetomidine to fentanyl-based intravenous patient controlled analgesia (PCA) reduces requirement of fentanyl bolus and consequent postoperative nausea and vomiting in high-risk patients undergoing lumbar spine surgery.

Enrollment: 108 patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. female, non-smoking patient who are 20-65 of age scheduled for elective lumbar spine surgery

Exclusion criteria

1. Bradycardia on EKG (45bpm)
2. Atrioventricular conduction disorder
3. Uncontrolled hypertension
4. angina history
5. obesity (BMI ≥ 30 kg/m2)
6. Preoperative administration of opioid
7. Preoperative administration of antiemetics
8. Gastrointestinal disorder history
9. Hepatic or renal disease
10. Pregnant 11. Foreigner

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 2 patient groups, including a placebo group

dexmedetomidine

Experimental group

Description:

addition of dexmedetomidine to fentanyl-based intravenous patient controlled analgesia (PCA)

Treatment:

Drug: dexmedetomidine

normal saline

Placebo Comparator group

Description:

normal saline as a placebo

Treatment:

Drug: normal saline