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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02593942
• Other study ID #: YTU-2014
• Status: Completed
• Phase: Phase 4
• First received: October 3, 2015
• Last updated: October 29, 2015
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: Yeditepe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Supratentorial Neoplasms

Intervention

Drug:
• Remifentanil
0.1-0.5 mcg/kg/min infusion
• Propofol
75-200 mcg/kg/min infusion

Locations

Country	Name	City	State
Turkey	Yeditepe University Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Yeditepe University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

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