Supratentorial Neoplasms Clinical Trial
Official title:
Effect of Remifentanil Infusion Alone During the Closure Period for Early Emergence and Hemodynamic Stability in Patients Undergoing Supratentorial Craniotomy
Verified date | October 2015 |
Source | Yeditepe University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Turkey | Yeditepe University Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Yeditepe University Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Heart Rate | Heart rate per minute was recorded | 6 hours | No |
Secondary | Mean arterial pressure were recorded | Mean arterial pressure (mmHg) was recorded | 6 hours | No |
Secondary | Post-anesthesia awaking time | Post-anesthesia awaking time assessed as the interval (min:sec)required to | 3 hours | No |
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