The effect of intravenous sedation on the lower oesophageal sphincter: A comparison between dexmedetomidine and remifentanil in healthy adult volunteers.
Dr Islam Elhalawani
16 participants
Sep 1, 2011
Interventional
Conditions
Summary
The primary aim of this study is to assess the effect of sedation on lower oesophageal sphincter (LOS) function and to compare the effects of two types of sedating drugs, Remifentanil and Dexmedetomidine, on LOS function. This is performed to assess the risk of aspiration during sedation both in theatres as well as the intensive care unit.
Eligibility
Inclusion Criteria1
- Healthy volunteers
Exclusion Criteria14
- (i) Inability to give informed consent
- (ii) Pregnancy or breast feeding
- (iii) Previous gastrointestinal surgery (apart from appendicectomy)
- (iv) medications known to affect gastrointestinal motility (erythromycin, metoclopramide and domperidone)
- (v) Clinically diagnosed gastro-oesophageal reflux disease and on acid suppression therapy
- (vi) Current use of opiates or any sedatives
- (vii) History of cardiac disease
- (viii) History of lung disease
- (ix) Smoking
- (x) Kidney disease
- (xi) Liver disease
- (xii) diabetes
- (xiii) Known allergy to anaesthetic drugs or any reported difficulties during previous anaesthesia
- (xiv) BMI > 33
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Interventions
Sedation of Healthy volunteers. Cross over study between 2 sedation medications: Remifentanil and Dexmedetomidine. Remifentanil Sedation: Target-Controlled Infusion: 0.1, 0.2, 0.3 and 0.4 mcg/Kg/min. Duration: 20 minutes at each target concentration. Period between cross-over: 1 week Target controlled infusions will be administered consecutively in an ascending pattern (lower to higher concentrations)
Locations(1)
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ACTRN12611000794909