A Comparison of Esmolol and Remifentanil to Reduce Blood Loss

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Diskapi Teaching and Research Hospital
Sponsor:
Information provided by (Responsible Party):
Dondu Ruveyda Acikgoz, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier:
NCT01752959
First received: December 4, 2012
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

In this prospective randomized study we aimed to compare the effects of esmolol and remifentanil on intraoperative bleeding surgical field conditions in nasal surgery


Condition Intervention Phase
Deviation Septum Nasal
Drug: Remifentanil
Drug: Esmolol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Randomized Comparison of Esmolol and Remifentanil on Intraoperative Bleeding and Surgical Field Conditionsin Nasal Surgery

Resource links provided by NLM:


Further study details as provided by Diskapi Teaching and Research Hospital:

Primary Outcome Measures:
  • the difference between group regarding blood loss [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
    controlled hypotension in nasal surgery


Secondary Outcome Measures:
  • the difference between groups regarding side effects and treatments [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
    side effects: more than 20% change in blood pressure and heart rate, treatment includes atropin, ephedrin, nitroglyserine


Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Remifentanyl
Group R 0.1-0.3 mic/kg/ min remifentanil infusion other names: Ultiva
Drug: Remifentanil
0.1-0.3 micg/kg/min Remifentanil iv infusion
Other Name: Ultiva
Experimental: esmolol
Grup E 500 micg/kg/min lading dose after 50-500 μcg/kg/dk esmolol infusion
Drug: Esmolol
500 μcg/kg/dk esmolol iv lading dose after 50-500 μcg/kg/dk esmolol iv infusion
Other Name: Brevibloc

Detailed Description:

60 patients with ASA I-IIphysical status assigned for septoplasty will be enrolled in this prospective randomized trial. A standardized anesthesia induction and intubation with propofol and rocuronium will be used. Patients will be randomized in two groups. Group Esmolol (Group E n=30) will receive esmolol 500 mic kg-1 loading dose and a 50-500 mic kg-1 min-1 infusion and Group Remifentanil (Group R n=30) will receive remifentanil 0.1-0.3 mic kg-1 min-1 infusion to induce controlled hypotension. A 50-60 mmHg mean arterial pressure and a minimum 50 beat min-1 heart rate is targeted. Heart rate, blood pressures, peripheral oxygen saturation and bispectral index spectrum (BIS) will be recorded. Anesthesia maintenance will be provided with O2/N2O and desflurane-propofol balanced anesthesia and a BIS value 40-60 is targeted. The quality of the surgical field will be assessed by the surgeon by using a 10 point visual analog scale (B1) and a 6 point scale (B2) during surgery with 5 minute intervals. The amount of bleeding will be calculated at the end of surgery from the amount of blood and irrigation fluid collected in the suction tube. All complications and side effects will be recorded.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-II,
  • between age 20-60

Exclusion Criteria:

  • patients having bleeding disorders,
  • arrhythmia,
  • hypertension,
  • endocrine, liver or kidney disease and
  • those who are on antihypertensive,
  • anticoagulant drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752959

Contacts
Contact: Ruveyda D Acikgoz, Trainee 0903125962554
Contact: Dilek Yazicioglu, Specialist 0903125962553 dilek.yazicioglu@hotmail.com

Locations
Turkey
Diskapi Yildirim Beyazit Training and Research Hospital Completed
Ankara, Turkey, 06110
Diskapi Yildirim Beyazit Training and Research Hospital Recruiting
Ankara, Turkey, 06610
Contact: Murat Alper, Proffesor    03125962242    muratalper@hotmail.com   
Sponsors and Collaborators
Diskapi Teaching and Research Hospital
Investigators
Principal Investigator: Ruveyda D Acıkgoz, Trainee Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.
  More Information

Publications:
Responsible Party: Dondu Ruveyda Acikgoz, Medical Doctor Trainee in Anesthesiology and Reanimation, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT01752959     History of Changes
Other Study ID Numbers: RAcikgozEsmolol
Study First Received: December 4, 2012
Last Updated: December 17, 2012
Health Authority: Turkey: Ministry of Health

Additional relevant MeSH terms:
Esmolol
Remifentanil
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on August 28, 2014