search
Back to results

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

Primary Purpose

Supratentorial Neoplasms

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Remifentanil
Propofol
Sponsored by
Yeditepe University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Supratentorial Neoplasms

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yeditepe University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

group I

group II

Arm Description

remifentanil

remifentanil, propofol

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Heart Rate
Heart rate per minute was recorded
Mean arterial pressure were recorded
Mean arterial pressure (mmHg) was recorded
Post-anesthesia awaking time
Post-anesthesia awaking time assessed as the interval (min:sec)required to

Full Information

First Posted
October 3, 2015
Last Updated
October 29, 2015
Sponsor
Yeditepe University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02593942
Brief Title
Remifentanil Infusion Alone During the Closure Period for Early Emergence Following Craniotomy
Official Title
Effect of Remifentanil Infusion Alone During the Closure Period for Early Emergence and Hemodynamic Stability in Patients Undergoing Supratentorial Craniotomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeditepe University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supratentorial Neoplasms

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group I
Arm Type
Experimental
Arm Description
remifentanil
Arm Title
group II
Arm Type
Experimental
Arm Description
remifentanil, propofol
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
Ultiva
Intervention Description
0.1-0.5 mcg/kg/min infusion
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
75-200 mcg/kg/min infusion
Primary Outcome Measure Information:
Title
Time of extubation
Description
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.
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Heart Rate
Description
Heart rate per minute was recorded
Time Frame
6 hours
Title
Mean arterial pressure were recorded
Description
Mean arterial pressure (mmHg) was recorded
Time Frame
6 hours
Title
Post-anesthesia awaking time
Description
Post-anesthesia awaking time assessed as the interval (min:sec)required to
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatice Ture, MD.
Organizational Affiliation
Yeditepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yeditepe University Hospital
City
Istanbul
ZIP/Postal Code
34752
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs