Skip to main content
Clinical Trials/NCT02593942
NCT02593942
Completed
Phase 4

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

Yeditepe University Hospital1 site in 1 country80 target enrollmentJanuary 2015

Overview

Phase
Phase 4
Intervention
Remifentanil
Conditions
Supratentorial Neoplasms
Sponsor
Yeditepe University Hospital
Enrollment
80
Locations
1
Primary Endpoint
Time of extubation
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
September 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Yeditepe University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Hatice Ture

Associate Professor

Yeditepe University Hospital

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
  • Breast feeding
  • Allergy to the study medications
  • History of cranial radiotherapy
  • Frontal bone flap

Arms & Interventions

group I

remifentanil

Intervention: Remifentanil

group II

remifentanil, propofol

Intervention: Remifentanil

group II

remifentanil, propofol

Intervention: Propofol

Outcomes

Primary Outcomes

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 Outcomes

  • Heart Rate(6 hours)
  • Mean arterial pressure were recorded(6 hours)
  • Post-anesthesia awaking time(3 hours)

Study Sites (1)

Loading locations...

Similar Trials