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Comparision Between Hemodynamic Response of Dexmedetomidine and Remifentanil on Anesthesia in Endoscopic Sinus Surgery

Comparision Between Hemodynamic Response of Dexmedetomidine and Remifentanil for Epinephrine Local Injection in Patient With Endoscopic Sinus Surgery Under General Anesthesia

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02464722
Enrollment
50
Registered
2015-06-08
Start date
2015-08-31
Completion date
2016-09-30
Last updated
2015-07-27

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

Conditions

Hemodynamic Instability

Keywords

Remifentanil, Dexmedetomidine, Endoscopic sinus surgery

Brief summary

During endoscopic sinus surgery (ESS), epinephrine local injection and controlled hypotension is essential in order to increase the visibility in the operative field and reduce the risk. This study is comparing of dexmedetomidine and remifentanil before epinephrine local injection for controlled hypotension during ESS.

Detailed description

During endoscopic sinus surgery (ESS), epinephrine local injection and controlled hypotension is essential in order to increase the visibility in the operative field and reduce the risk. Epinephrine local injection and controlled hypotensive anesthesia is commonly used in several surgical interventions using different techniques. However, choosing the ideal agent is still a controversial topic. In the current study, the effects and safety of remifentanil, which is an μ opioid receptor agonist and dexmedetomidine, an α-2 agonist; when used before epinephrine local injection for controlled hypotension in ESS, are compared. After obtaining Institutional Review Board approval and written informed consent, 40 patients is enrolling in this study. Participants is divided by two groups randomly as the Dexmedetomidine group and the Remifentanil group. A correctly sized facemask and 100 % oxygen was used for pre-oxygenation. General anesthesia was induced with iv Propofol 1.5-2 mg kg-1. Endotracheal intubation was performed with the aid of iv Rocuronium 0.6 kg-1. Ventilation was controlled with 50% air in oxygen to maintain end-tidal carbon dioxide pressure at 30-36 mmHg. Desflurane was used for maintenance. Before epinephrine injection, In group Remifentanil, Participants received 1 mcg kg-1 iv loading dose of remifentanil over a period of 60 seconds. Later, an infusion was started at the rate of 0.2-0.4 mcg kg-1 h-1. The infusion rate was adjusted according to the Participants response, to achieve a mean arterial pressure between 60 and 75 mmHg. In group Dexmedetomidine, patients received a 1 mcg kg-1 loading dosage of dexmedetomidine within 10 min and later, infusion was started at the rate of 0.4-0.8 mcg kg-1min-1. The infusions began before tracheal intubation in both groups. Standard dose epinephrine local infiltration was administered to the nasal passages by the surgeon. Systolic Arterial Pressure,Diastolic Arterial Pressure,Mean arterial blood pressure, Heart Rate were recorded every 5min, from the beginning of anesthesia and every 1min, from the epinephrine local injection. Perioperative hypotension and bradycardia were defined as mean arterial blood pressure \< 50 mmHg or 50 beat/min respectively. Ephedine was administered intravenously for the treatment of hypotension. Atropine 0.5 mg was administered intravenously for the treatment of bradycardia. All infusions were stopped 5 min before the end of surgery. After surgery, the surgeon evaluated the dryness of the surgical area. Recovery time was recorded in the postoperative period. An investigators employing the Modified Observer's Assessment of Alertness/Sedation Scale assessed recovery.

Interventions

DRUGDexmedetomidine

1 mcg/kg iv loading dose of remifentanil over a period of 60 seconds. Later, an infusion was started at the rate of 0.2-0.4mcg/kg/min.

DRUGRemifentanil

1 mcg/kg iv loading dose of remifentanil over a period of 10 minutes. Later, an infusion was started at the rate of 0.4-0.8mcg/kg/min.

DRUGEpinephrine

Before the start of surgery, 1/100000 epinephrine infiltration was administered to the nasal passages by the surgeon.

DRUGPropofol

Anesthesia was induced with propofol 2 mg kg-1

DRUGRocuronium

Anesthesia was induced with rocuronium 0.6 mg kg-1

Sponsors

Korea University Anam Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* American Society of Anesthesiologist\[ASA\] class 1-2 * scheduled Endoscopic sinus surgery * written informed consent

Exclusion criteria

* allergy of opioids, neuromuscular blocking drugs or other medications used during general anesthesia * known or suspected upper respiratory infection * suspected difficult tracheal intubation * Uncontrolled Hypertension * known or suspected psychologic disorder * known or suspected significant renal dysfunction * known or suspected severe hepatic dysfunction * known or suspected significant cardiovascular dysfunction

Design outcomes

Primary

MeasureTime frame
Change in blood pressureAt the time from epinephrine local injection (1,2,3,4,5,6,7,8,9,10,11,12,13,14,15 minutes)

Secondary

MeasureTime frameDescription
Conditions during SurgeryAt the time during SurgeryWe assessed conditions during ESS(Surgeon evaluated the dryness of the surgical area using six point quality scale.)

Other

MeasureTime frame
Change in heart rateAt the time from epinephrine local injection (1,2,3,4,5,6,7,8,9,10,11,12,13,14,15 minutes)

Outcome results

None listed

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