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

Study Overview
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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.

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.

Official Title
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Effect of Remifentanil Infusion Alone During the Closure Period for Early Emergence and Hemodynamic Stability in Patients Undergoing Supratentorial Craniotomy

Conditions
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Supratentorial Neoplasms

Intervention / Treatment
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* Drug: Remifentanil
* Drug: Propofol


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group I<br>remifentanil | Drug: Remifentanil<br>* 0.1-0.5 mcg/kg/min infusion<br>* Other names: Ultiva;|
| Experimental: group II<br>remifentanil, propofol | Drug: Remifentanil<br>* 0.1-0.5 mcg/kg/min infusion<br>* Other names: Ultiva;Drug: Propofol<br>* 75-200 mcg/kg/min infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of extubation | After the surgery, starting from three-pin head holder removal, an investigator asked each patient to open his or her eyes, squeeze the investigator's hand. When the patient opened his or her eyes, obeyed commands, resumed adequate respiration, hemodynamically stable and bispectral index spectrum > 70-80 was extubated, and the time will be recorded. The patients will be followed for an expected average of 3 hours. | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | Heart rate per minute was recorded | 6 hours | 
| Mean arterial pressure were recorded | Mean arterial pressure (mmHg) was recorded | 6 hours | 
| Post-anesthesia awaking time | Post-anesthesia awaking time assessed as the interval (min:sec)required to | 3 hours |