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NCT Number: NCT02593942

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

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Key information

Conditions

Supratentorial Neoplasms Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yeditepe University Hospital

Istanbul, 34752, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

Drug

0.1-0.5 mcg/kg/min infusion

Other names: Ultiva

Propofol

Drug

75-200 mcg/kg/min infusion

Primary outcomes

  1. Time of extubation

    Time frame: 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 outcomes

  1. Heart Rate

    Time frame: 6 hours

    Heart rate per minute was recorded

  2. Mean arterial pressure were recorded

    Time frame: 6 hours

    Mean arterial pressure (mmHg) was recorded

  3. Post-anesthesia awaking time

    Time frame: 3 hours

    Post-anesthesia awaking time assessed as the interval (min:sec)required to

Sponsors and collaborators

Lead sponsor

Yeditepe University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 2, 2015
Registry last updated
Nov 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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