Remifentanil Infusion Alone During the Closure Period for Early Emergence Following Craniotomy
Effect of Remifentanil Infusion Alone During the Closure Period for Early Emergence and Hemodynamic Stability in Patients Undergoing Supratentorial Craniotomy
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2015
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 3, 2015
CompletedFirst Posted
Study publicly available on registry
November 2, 2015
CompletedNovember 2, 2015
October 1, 2015
8 months
October 3, 2015
October 29, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Heart Rate
6 hours
Mean arterial pressure were recorded
6 hours
Post-anesthesia awaking time
3 hours
Study Arms (2)
group I
EXPERIMENTALremifentanil
group II
EXPERIMENTALremifentanil, propofol
Interventions
Eligibility Criteria
You may qualify if:
- American Society of Anaesthesiologist physical status I-II
- Glasgow Coma Scale score of 15 points
- Elective supratentorial craniotomy for tumor resection
- Supine position
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yeditepe University Hospital
Istanbul, 34752, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hatice Ture, MD.
Yeditepe University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 3, 2015
First Posted
November 2, 2015
Study Start
January 1, 2015
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
November 2, 2015
Record last verified: 2015-10