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

Hemodynamic Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02464722
• Other study ID #: ED15010
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: May 27, 2015
• Last updated: July 23, 2015
• Start date: August 2015
• Est. completion date: September 2016

Study information

• Verified date: July 2015
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: September 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hemodynamic Instability

Intervention

Drug:
• Dexmedetomidine
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.
• Remifentanil
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.
• Epinephrine
Before the start of surgery, 1/100000 epinephrine infiltration was administered to the nasal passages by the surgeon.
• Propofol
Anesthesia was induced with propofol 2 mg kg-1
• Rocuronium
Anesthesia was induced with rocuronium 0.6 mg kg-1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

References & Publications (1)

Lee J, Kim Y, Park C, Jeon Y, Kim D, Joo J, Kang H. Comparison between dexmedetomidine and remifentanil for controlled hypotension and recovery in endoscopic sinus surgery. Ann Otol Rhinol Laryngol. 2013 Jul;122(7):421-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in heart rate		At the time from epinephrine local injection (1,2,3,4,5,6,7,8,9,10,11,12,13,14,15 minutes)	No
Primary	Change in blood pressure		At the time from epinephrine local injection (1,2,3,4,5,6,7,8,9,10,11,12,13,14,15 minutes)	No
Secondary	Conditions during Surgery	We assessed conditions during ESS(Surgeon evaluated the dryness of the surgical area using six point quality scale.)	At the time during Surgery	No