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

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

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.

Study Overview

• Status: Completed
• Conditions: Supratentorial Neoplasms
• Intervention / Treatment: Drug: Remifentanil; Drug: Propofol

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34752
    • Yeditepe University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group I; remifentanil	Drug: Remifentanil; 0.1-0.5 mcg/kg/min infusion; Other Names: Ultiva
Experimental: group II; remifentanil, propofol	Drug: Remifentanil; 0.1-0.5 mcg/kg/min infusion; Other Names: Ultiva; Drug: Propofol; 75-200 mcg/kg/min infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	Heart rate per minute was recorded	6 hours
Mean arterial pressure were recorded	Mean arterial pressure (mmHg) was recorded	6 hours
Post-anesthesia awaking time	Post-anesthesia awaking time assessed as the interval (min:sec)required to	3 hours

Collaborators and Investigators

• Sponsor: Yeditepe University Hospital
• Investigators: Principal Investigator: Hatice Ture, MD., Yeditepe University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: October 3, 2015
• First Submitted That Met QC Criteria: October 29, 2015
• First Posted (Estimate): November 1, 2015

Study Record Updates

• Last Update Posted (Estimate): November 1, 2015
• Last Update Submitted That Met QC Criteria: October 29, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Supratentorial Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Remifentanil; Propofol
• Other Study ID Numbers: YTU-2014