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A Comparison of Esmolol and Remifentanil to Reduce Blood Loss

NCT ID: NCT01752959

Last Updated: 2012-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Deviation Septum Nasal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Remifentanyl

Group R 0.1-0.3 mic/kg/ min remifentanil infusion other names: Ultiva

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

0.1-0.3 micg/kg/min Remifentanil iv infusion

esmolol

Grup E 500 micg/kg/min lading dose after 50-500 μcg/kg/dk esmolol infusion

Group Type EXPERIMENTAL

Esmolol

Intervention Type DRUG

500 μcg/kg/dk esmolol iv lading dose after 50-500 μcg/kg/dk esmolol iv infusion

Interventions

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Remifentanil

0.1-0.3 micg/kg/min Remifentanil iv infusion

Intervention Type DRUG

Esmolol

500 μcg/kg/dk esmolol iv lading dose after 50-500 μcg/kg/dk esmolol iv infusion

Intervention Type DRUG

Other Intervention Names

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Ultiva Brevibloc

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dondu Ruveyda Acikgoz

Medical Doctor Trainee in Anesthesiology and Reanimation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ruveyda D Acıkgoz, Trainee

Role: PRINCIPAL_INVESTIGATOR

Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.

Locations

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Diskapi Yildirim Beyazit Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status COMPLETED

Diskapi Yildirim Beyazit Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ruveyda D Acikgoz, Trainee

Role: CONTACT

Phone: 0903125962554

Dilek Yazicioglu, Specialist

Role: CONTACT

Phone: 0903125962553

Email: [email protected]

Facility Contacts

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Murat Alper, Proffesor

Role: primary

References

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Degoute CS, Ray MJ, Manchon M, Dubreuil C, Banssillon V. Remifentanil and controlled hypotension; comparison with nitroprusside or esmolol during tympanoplasty. Can J Anaesth. 2001 Jan;48(1):20-7. doi: 10.1007/BF03019809.

Reference Type BACKGROUND
PMID: 11212044 (View on PubMed)

Shen PH, Weitzel EK, Lai JT, Wormald PJ, Ho CS. Intravenous esmolol infusion improves surgical fields during sevoflurane-anesthetized endoscopic sinus surgery: a double-blind, randomized, placebo-controlled trial. Am J Rhinol Allergy. 2011 Nov-Dec;25(6):e208-11. doi: 10.2500/ajra.2011.25.3701.

Reference Type BACKGROUND
PMID: 22185726 (View on PubMed)

Other Identifiers

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RAcikgozEsmolol

Identifier Type: -

Identifier Source: org_study_id