Skip to content

Does substituting isoflurane with propofol during the last hour of intracranial surgery shorten recovery time and reduce PONV?

Does substituting isoflurane with propofol during the last hour of intracranial surgery shorten recovery time and reduce PONV?

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-003346-42-SE
Enrollment
Unknown
Registered
2006-06-22
Start date
2006-09-14
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative nausea and vomiting (PONV) and postoperative recovery time.

Interventions

Trade Name: Propofol-Lipuro Pharmaceutical Form: Intravenous infusion Trade Name: Forene Pharmaceutical Form: Inhalation vapour, liquid

Sponsors

University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: This study will include patients scheduled for elective intracranial surgery, positioned with Mayfield head-rest and with an expected anesthesia time of at least 4 hours. Patients in the age of 18-75 with ASA physical status ?-?? will be included in the study. Approval by the local ethics committee and written informed consent will be obtained from each patient. The patients will be under betamethason treatment, due to the intracranial process. The number of patients that this study will include is 80. The patients will be randomly assigned to one of two groups: Group C, (Control) will receive inhalation anesthesia with isoflurane during the whole procedure. Group P (Propofol) will receive isoflurane until the surgeon starts to close the dura, then the isoflurane will be discontinued and propofol infusion will be used instead during the remainder of surgery. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Criteria of exclusion will be severe cardiac infarction or if the condition of the patient demands another type of anesthesia than that described above.

Design outcomes

Primary

MeasureTime frame
Main Objective: Neurosurgery is normally associated with a high incidence of postoperative nausea and vomiting (PONV), especially in patients undergoing craniotomy for intracranial surgery, positioned in Mayfield head-rest and with duration of anesthesia for 4 hours or more. Balanced anesthesia with isoflurane-fentanyl has been widely accepted as an anesthetic management for neurosurgery. This approach will, however, give a rather slow recovery, associated with a high frequency of PONV. A different technique is intravenous anesthesia with propofol-fentanyl. Propofol is associated with a shorter recovery time and less PONV. Unfortunately propofol during longer anesthesia, is associated with a higher cost. The aim of the study is to find out, if finishing an isoflurane-fentanyl anesthesia with propofol will lead to less PONV and a shorter recovery time.;Secondary Objective: No;Primary end point(s): The degree of postopeative pain and PONV is evaluated by Visual Analog Scale (VAS), a validated instrument. The recovery time in the two groups will be compared.

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026