A Comparison of Esmolol and Remifentanil to Reduce Blood Loss

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2012 by Diskapi Teaching and Research Hospital.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Dondu Ruveyda Acikgoz, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier:
First received: December 4, 2012
Last updated: December 17, 2012
Last verified: December 2012
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.

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

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

ClinicalTrials.gov processed this record on May 24, 2016