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

Phase 4

Completed

• Conditions: Supratentorial Neoplasms
• Interventions: Drug: Remifentanil; Drug: Propofol

• Registration Number: NCT02593942
• Lead Sponsor: Yeditepe University Hospital

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.

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-10
• Study First Submitted: 2015-10-03
• Study First Submitted QC: 2015-10-29
• Last Update Submitted: 2015-10-29
• Study First Posted: 2015-11-01
• Last Update Posted: 2015-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group I	Remifentanil	remifentanil
group II	Remifentanil	remifentanil, propofol
group II	Propofol	remifentanil, propofol

Primary Outcome Measures

Name	Time	Method
Time of extubation	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 Outcome Measures

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

Trial Locations

Locations (1)

Yeditepe University Hospital; 🇹🇷 Istanbul, Turkey