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NCT Number: NCT04691128

Desflurane and Brain Relaxation in Craniotomy

Optional brain relaxation improves the surgeon's operating conditions and is likely to minimize the degree of retraction injury ,with the potential for providing patients with a better outcome. The choice of anesthetic drugs can affect intraoperative brain relaxation. Propofol suppresses brain metabolism, reduces cerebral blood flow, and provides satisfactory brain relaxation. Desflurane is often criticized in neurosurgery due to its cerebral vasodilation and potential to increase intracranial pressure, however, it has been found to have a little clinical significance. This study intends to compare the effects of desflurane with propofol on brain relaxation in patients with supratentorial tumors under mild hyperventilation, and to provide new clinical evidence for the use of desflurane in neurosurgical anesthesia.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

About this study

To compare the effect of desflurane versus propofol combined with remifentanil anesthesia on brain relaxation in patients undergoing supratentorial tumor surgery with mild hyperventilation, and compare the emergence time and common complications during recovery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-60 years
  • Scheduled for elective craniotomy for supratentorial cerebral tumors
  • ASA status I-III
  • Glasgow score of 15
  • No clinical signs of intracranial hypertension
  • Preoperative brain imaging (CT or MRI) with midline shift less than 5mm
  • Informed consent signed by patients

Exclusion criteria

  • Scheduled intraoperative motor evoked potential monitoring
  • Patients with cerebral vascular diseases
  • Uncontrolled cardiopulmonary disease
  • Schedule to retain tracheal intubation after surgery
  • Unable to comprehend and cooperate with the examination
  • BMI > 30 Kg/m-2
  • Emergency surgery
  • History of related anesthetic allergy

Treatment and study plan

Desflurane

Drug

After induction, anesthesia will be maintained with 0.8-1.3 MAC desflurane and 0.05-0.2 μg/kg/min remifentanil.

Other names: inhalational anesthesia

Propofol

Drug

After induction, anesthesia will be maintained with 6-8 mg/kg/h propofol and 0.05- 0.2 μg/kg/min remifentanil

Other names: TIVA, total intravenous anesthesia

Primary outcomes

  1. Proportion of satisfactory brain relaxation

    Time frame: during surgery

    Assessed by the neurosurgeon using a 4-point scale (1= perfectly relaxed, 2= satisfactorily relaxed, 3= firm brain, 4=bulging brain) at the opening of the dura mater, score 1 and 2 represent satisfactory brain relaxation

Secondary outcomes

  1. Emergence time

    Time frame: from drug discontinuation to eye opening, assessed up to 1 hours

    from drug discontinuation to eye opening

  2. Extubation time

    Time frame: from drug discontinuation to tracheal extubation, assessed up to 1 hours

    from drug discontinuation to tracheal extubation

  3. Postoperative complications

    Time frame: from drug discontinuation to discharge from PACU (Postanesthesia care unit), assessed up to 3 hours

    incidence of hypoxemia, hypotension, hypertension, tachycardia, bradycardia, agitation, shivering.

  4. Postoperative pain and postoperative nausea and vomiting (PONV)

    Time frame: during the PACU stay and postoperative day 1.

    evaluated by Visual Analogue Score(VAS).

  5. Duration in PACU (Postanesthesia care unit)

    Time frame: from entering PACU to exiting PACU, an expected average of 1 hour

    time from entering PACU to exiting PACU

  6. Early postanesthesia cognitive recovery

    Time frame: at 15, 30min after tracheal extubation

    evaluated by Short Orientation Memory Concentration Test (SOMCT)

  7. Dural tension

    Time frame: during surgery

    evaluated using a 4-point scale after bone flap removal.

  8. Quality of anesthesia recovery

    Time frame: at postoperative day 1

    assessed by quality of recovery-15 scale (QoR-15)

  9. Anesthesia expenses

    Time frame: at postoperative day 1

    Total cost of anesthesia

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

Comparison of Desflurane and Propofol for Brain Relaxation in Patients Undergoing Supratentorial Craniotomy：a Randomized Controlled Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 31, 2020
Registry last updated
Oct 26, 2021

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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