MedTrace Logo

Preop Dexmedetomidine Attenuates Haemodynamic Responses to Hydrodissection

NCT02102139 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2014-04-02

No results posted yet for this study

Summary

Percutaneous tunnelling (hydrodissection) in the neck and anterior chest in patients undergoing robotic thyroidectomy leads to significant haemodynamic responses such as increases in blood pressure and heart rate. The investigators evaluated whether a single preoperative dexmedetomidine injection attenuated the haemodynamic responses to hydrodissection by reducing the half-maximal effective concentration (EC50) of remifentanil needed to maintain haemodynamic stability during hydrodissection.

Conditions

  • Robotic Thyroidectomy

Interventions

DRUG

DXM + Propofol

After induction as mentioned at 'arm description', the effect-site propofol concentration was fixed at 5.0 μg mL-1 at the time of diluted epinephrine injection and was unchanged during the entire hydrodissection period in all patients. The first patients received effect-site concentrations of remifentanil of 4 ng mL -1, respectively. The EC50 of remifentanil for stable hydrodissection was determined by a modification of Dixon's up-and-down method.If the response was "success (SBP during the entire hydrodissection period being ±20% from baseline)," the next target concentration of remifentanil was decreased by a step of 0.5 ng mL -1. If the response was "fail(SBP \> ±20% from baseline)," the target concentration was increased by 0.5 ng mL-1.

DRUG

Saline + Propofol

All procedure would be same in DXM+Propofol group except saline loading rather than DXM loading before induction.

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Hee Pyung Park, MD PhD · Professor

  • Young Jin Lim, Md PhD · Professor

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02102139 on ClinicalTrials.gov