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

NCT02464722 | Unknown Phase 4 DMC

• 1 other identifier: ED15010
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hemodynamic Instability

Keywords

Remifentanil; Dexmedetomidine; Endoscopic sinus surgery

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Conditions during Surgery

  At the time during Surgery

Other Outcomes (1)

• 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)

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

1. Before induction of Anesthesia, 1 mcg/kg iv loading dose of dexmedetomidine over 10 minutes. 2. Anesthesia was induced with propofol 2 mg kg-1 , rocuronium 0.6 mg kg-1 3. After Mask ventilation with 6 vol% desflurane in 100% oxygen for 3 minutes, tracheal intubation was done 4. Later, an infusion was started at the rate of 0.4-0.8mcg/kg/min. The infusion rate was adjusted according to the patient's response, to achieve a mean arterial pressure between 60 and 80 mmHg. 5. Before the start of surgery, 1/100000 epinephrine infiltration was administered to the nasal passages by the surgeon. 6. At the end of surgery, discontinuation of desflurane and dexmedetomidine, sending recovery room.

Drug: Dexmedetomidine; Drug: Epinephrine; Drug: Propofol; Drug: Rocuronium

Remifentanil

ACTIVE COMPARATOR

1. Anesthesia was induced with propofol 2 mg kg-1 , rocuronium 0.6 mg kg-1 2. Mask ventilation with 6 vol% desflurane in 100% oxygen for 2 minutes. 3. After 1 mcg/kg iv loading dose of remifentanil over a period of 1 minutes. tracheal intubation was done. 4. Later, an infusion was started at the rate of 0.2-0.4mcg/kg/min. The infusion rate was adjusted according to the patient's response, to achieve a mean arterial pressure between 60 and 80 mmHg. 5. Before the start of surgery, 1/100000 epinephrine infiltration was administered to the nasal passages by the surgeon. 6. At the end of surgery, discontinuation of desflurane and remifentanil, sending recovery room.

Drug: Remifentanil; Drug: Epinephrine; Drug: Propofol; Drug: Rocuronium

Interventions

Dexmedetomidine DRUG

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.

Also known as: dexmedetomidine hydrochloride

Dexmedetomidine

Remifentanil DRUG

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.

Also known as: remifentanil hydrochloride

Remifentanil

Epinephrine DRUG

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

Dexmedetomidine; Remifentanil

Propofol DRUG

Anesthesia was induced with propofol 2 mg kg-1

Dexmedetomidine; Remifentanil

Rocuronium DRUG

Anesthesia was induced with rocuronium 0.6 mg kg-1

Dexmedetomidine; Remifentanil

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Related 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. doi: 10.1177/000348941312200702.

  PMID: 23951692 RESULT

MeSH Terms

Interventions

Dexmedetomidine; Remifentanil; Epinephrine; Propofol; Rocuronium

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jangeun Cho, M.D, Ph.D

  Anesthesia and Pain medicine department, Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 8, 2015
• Study Start: August 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: September 1, 2016
• Last Updated: July 27, 2015

Record last verified: 2015-07