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A Comparison of Esmolol and Remifentanil to Reduce Blood Loss

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ClinicalTrials.gov Identifier: NCT01752959
Recruitment Status : Unknown
Verified December 2012 by Dondu Ruveyda Acikgoz, Diskapi Teaching and Research Hospital.
Recruitment status was:  Recruiting
First Posted : December 19, 2012
Last Update Posted : December 19, 2012
Information provided by (Responsible Party):
Dondu Ruveyda Acikgoz, Diskapi Teaching and Research Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Deviation Septum Nasal Drug: Remifentanil Drug: Esmolol Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Randomized Comparison of Esmolol and Remifentanil on Intraoperative Bleeding and Surgical Field Conditionsin Nasal Surgery
Study Start Date : July 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. the difference between group regarding blood loss [ Time Frame: intraoperative ]
    controlled hypotension in nasal surgery

Secondary Outcome Measures :
  1. the difference between groups regarding side effects and treatments [ Time Frame: intraoperative ]
    side effects: more than 20% change in blood pressure and heart rate, treatment includes atropin, ephedrin, nitroglyserine

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01752959

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

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
Principal Investigator: Ruveyda D Acıkgoz, Trainee Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.

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
First Posted: December 19, 2012    Key Record Dates
Last Update Posted: December 19, 2012
Last Verified: December 2012

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