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

Yeditepe University Hospital

Status and phase: Completed; Phase 4

Conditions: Supratentorial Neoplasms

Treatments: Drug: Propofol; Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT02593942

YTU-2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

group I

Experimental group

Description:

remifentanil

Treatment:

Drug: Remifentanil

group II

Experimental group

Description:

remifentanil, propofol

Treatment:

Drug: Propofol

Drug: Remifentanil