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

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ClinicalTrials.gov Identifier: NCT02593942
Recruitment Status : Completed
First Posted : November 2, 2015
Last Update Posted : November 2, 2015
Sponsor:
Information provided by (Responsible Party):
Hatice Ture, Yeditepe University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Supratentorial Neoplasms Drug: Remifentanil Drug: Propofol Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Remifentanil Infusion Alone During the Closure Period for Early Emergence and Hemodynamic Stability in Patients Undergoing Supratentorial Craniotomy
Study Start Date : January 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: group I
remifentanil
Drug: Remifentanil
0.1-0.5 mcg/kg/min infusion
Other Name: Ultiva

Experimental: group II
remifentanil, propofol
Drug: Remifentanil
0.1-0.5 mcg/kg/min infusion
Other Name: Ultiva

Drug: Propofol
75-200 mcg/kg/min infusion




Primary Outcome Measures :
  1. Time of extubation [ Time Frame: 3 hours ]
    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.


Secondary Outcome Measures :
  1. Heart Rate [ Time Frame: 6 hours ]
    Heart rate per minute was recorded

  2. Mean arterial pressure were recorded [ Time Frame: 6 hours ]
    Mean arterial pressure (mmHg) was recorded

  3. Post-anesthesia awaking time [ Time Frame: 3 hours ]
    Post-anesthesia awaking time assessed as the interval (min:sec)required to



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02593942


Locations
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Turkey
Yeditepe University Hospital
Istanbul, Turkey, 34752
Sponsors and Collaborators
Yeditepe University Hospital
Investigators
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Principal Investigator: Hatice Ture, MD. Yeditepe University

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Responsible Party: Hatice Ture, Associate Professor, Yeditepe University Hospital
ClinicalTrials.gov Identifier: NCT02593942     History of Changes
Other Study ID Numbers: YTU-2014
First Posted: November 2, 2015    Key Record Dates
Last Update Posted: November 2, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
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Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Remifentanil
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents