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

NCT01840254 | Completed

• 1 other identifier: 4-2012-0490
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PONV

Keywords

PONV; IV PCA; dexmedetomidine; Female; non-smoking; lumbar spine surgery

Outcome Measures

Primary Outcomes (1)

• total dose and bolus administration of opioid

  After induction of anesthesia, peak velocity of carotid artery blood flow is measured by the pulsed wave Doppler signal obtained from the left common carotid artery. Respirophasic variation of the peak velocity is defined as the difference between the maximum and the minimum values of peak velocity divided by the mean of the two values during one respiratory cycle. Fluid responder is defined as a patient whose stroke volume index is increased ≥15% after volume expansion. The receiver operating characteristic curve analysis to discriminiate fludi responder is performed.

  an expected average of 48 hrs for requirements of total dose and number of bolus administration of PCA

Secondary Outcomes (1)

• consequent postoperative nausea and vomiting

  an expected average of 48 hrs for assessing of the 11-points verbal numerical rating scales

Study Arms (2)

dexmedetomidine

EXPERIMENTAL

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

Drug: dexmedetomidine

normal saline

PLACEBO COMPARATOR

normal saline as a placebo

Drug: normal saline

Interventions

dexmedetomidine DRUG

dexmedetomidine

normal saline DRUG

normal saline

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Bradycardia on EKG (45bpm)
• Atrioventricular conduction disorder
• Uncontrolled hypertension
• angina history
• obesity (BMI ≥ 30 kg/m2)
• Preoperative administration of opioid
• Preoperative administration of antiemetics
• Gastrointestinal disorder history
• Hepatic or renal disease
• Pregnant 11. Foreigner

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University College of Medicine

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (1)

• Song Y, Shim JK, Song JW, Kim EK, Kwak YL. Dexmedetomidine added to an opioid-based analgesic regimen for the prevention of postoperative nausea and vomiting in highly susceptible patients: A randomised controlled trial. Eur J Anaesthesiol. 2016 Feb;33(2):75-83. doi: 10.1097/EJA.0000000000000327.

  PMID: 26258655 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 25, 2013
• Study Start: September 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 7, 2014

Record last verified: 2014-02

Locations

KR (1)