Remifentanil Infusion Alone During the Closure Period for Early Emergence Following Craniotomy

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-09-30

Brief Summary

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Total intravenous anaesthesia using propofol and remifentanil are routinely used drugs for this purpose. The hemodynamic stability and at the same time early emergency are the main goals following neurosurgery. However there is no standard for discontinuation time for manually controlled systems today.

The investigators aimed to study the effect of remifentanil infusion alone for early emergence and hemodynamic stability during the closure period in patients undergoing supratentorial craniotomy.

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Detailed Description

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Adult, American society of Anaesthesiologist score I-II, 80 patients who underwent elective supratentorial craniotomy for tumour resection were randomly assigned to group I or II. In group I; propofol was discontinued during the dural closure. After the propofol was discontinued, remifentanil dose was increased with the guidance of bispectral index spectrum and hemodynamic parameters. In group II; propofol discontinued before the end of the surgery. Time to awakening and extubation time, adverse events, total remifentanil and propofol consumptions and side effects were recorded. Heart rate and blood pressure were recorded during this period.

Conditions

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Supratentorial Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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group I

remifentanil

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

0.1-0.5 mcg/kg/min infusion

group II

remifentanil, propofol

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

0.1-0.5 mcg/kg/min infusion

Propofol

Intervention Type DRUG

75-200 mcg/kg/min infusion

Interventions

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Remifentanil

0.1-0.5 mcg/kg/min infusion

Intervention Type DRUG

Propofol

75-200 mcg/kg/min infusion

Intervention Type DRUG

Other Intervention Names

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Ultiva

Eligibility Criteria

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Inclusion Criteria

* American Society of Anaesthesiologist physical status I-II
* Glasgow Coma Scale score of 15 points
* Elective supratentorial craniotomy for tumor resection
* Supine position

Exclusion Criteria

* Obese patient
* Brain tumor greater than 30 mm in diameter
* Postoperative cranial drainage
* Hypertension
* Diabetes mellitus
* Reoperation
* Pregnant
* Breast feeding
* Allergy to the study medications
* History of cranial radiotherapy
* Frontal bone flap
* Intraoperative neuromonitoring

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No