The effect of intravenous sedation on the lower oesophageal sphincter: A comparison between dexmedetomidine and remifentanil in healthy adult volunteers.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000794909

Enrollment

Registered

2011-07-28

Start date

2011-09-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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)

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy volunteers

Exclusion criteria

(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

Outcome results