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Preop Dexmedetomidine Attenuates Haemodynamic Responses to Hydrodissection

A Single Preoperative Injection of Dexmedetomidine Attenuates Haemodynamic Responses to Hydrodissection in Patients Undergoing Robotic Thyroidectomy: a Prospective Randomised Double-blinded Study

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02102139
Acronym
DXM_Hydro
Enrollment
41
Registered
2014-04-02
Start date
2012-05-31
Completion date
2012-09-30
Last updated
2014-04-02

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

Conditions

Robotic Thyroidectomy

Brief 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.

Detailed description

Dexmedetomidine (DXM) is a recently released and approved alpha 2 agonist with a relatively high ratio of α2/α1-activity and an almost fourfold shorter half-life than clonidine.It's sympatholytic, sedative, and analgesic properties makes DXM a useful anaesthetic adjuvant for general anaesthesia. While there are some reports of the beneficial effects of DXM on anaesthetic requirements and haemodynamic responses to endotracheal intubation, the effect of a single preoperative injection of DXM in terms of attenuating haemodymanic responses to surgical stimulation in robot-assisted thyroidectomy is unknown. When a robotic thyroidectomy using the bilateral axillary breast approach (BABA) technique is performed, subcutaneous tunnelling in the neck and anterior chest, which is defined as hydrodissection, is mandatory. Unfortunately, the procedure leads to significant haemodynamic responses, such as increases in blood pressure and heart rate. We hypothesised that preoperative DXM administration would attenuate the haemodynamic responses to hydrodissection. This study was designed to evaluate the effects of a single preoperative administration of DXM on haemodynamic responses to hydrodissection in robotic thyroidectomy by comparing the half-maximal effective concentration (EC50) of remifentanil needed to maintain haemodynamic stability during hydrodissection between DXM and control groups. We also investigated the effects of preoperative DXM administration on total doses of remifentanil and propofol administered intraoperatively.

Interventions

DRUGDXM + 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.

DRUGSaline + Propofol

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* ASA physical status I-II patientsscheduled for general anaesthesia for robotic thyroidectomy

Exclusion criteria

* Patients with an allergy to α2-adrenergic agonists or propofol * Patients with current antihypertensive medication * Patients with heart block \> 1 degree * Patients with severe cardiorespiratory dysfunction * Patients with history of alcohol or drug abuse * Patients who had received an opioid analgesic medication within the previous 24-h period before the operation

Design outcomes

Primary

MeasureTime frameDescription
Remifentanil EC50 during hydrodissectionat the time point of hydrodissection intraopeartivelyCompare remifentanil EC50 for maintaining haemodynamic stability during hydrodissection between 2 groups. The EC50 of remifentanil for maintaining haemodynamic stability 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.

Secondary

MeasureTime frameDescription
Total doses of remifentanil & propofol administrationIntraoperativelyCompare total doses of remifentanil and propofol administered intraoperatively between 2 groups.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026