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Completed

NCT Number: NCT00389883

Anaesthesia for Supratentorial Tumor Resection

This is a double center, multidisciplinary, prospective, randomized, double-blind, with a superiority hypothesis, trial including 100 patients scheduled for resection of a supratentorial brain tumour under general anesthesia.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Hospitalier Universitaire., Besançon, France

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About this study

On the morning of surgery, patients will be randomly allocated to one of the two following groups : target concentration-delivered propofol-remifentanil versus sufentanil-sevoflurane. The primary judgement criterion will be the rapidity of awakening, defined as the time between the cessation of administration of the last anesthetic until extubation. Several secondary judgement criteria related to quality of postoperative recovery and complications will be collected. The hypothesis tested is a 30% reduction of the time necessary to extubate patients after cessation of anesthetic delivery in the propofol-remifentanil group. Based on previous works, using an risk of 20 % and an of 5 %, 100 patients must be included in this study (50 or each group). Statistical analysis will be performed by WILCOXON MANN, WHITNEY and X2 tests based on the type of variables.

The results of this study should provide a first choice anaesthetic regimen to optimize postoperative recovery of neurosurgical patients undergoing resection of supratentorial brain tumours. They will contribute to the improvement in the management of patients suffering from cancer.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient scheduled for supratentorial brain tumors remove.
  • Age : 18 to 75.
  • ASA 1 or 2.

Exclusion criteria

  • Disagree of patient to participate
  • Intubation required in the postoperative care unit
  • Contraindication of one of the anesthetics used in the study
  • Pregnancy
  • Craniotomy in the frontal area (no depth of anesthesia monitoring)
  • Patient's inability to quantified its pain.

Treatment and study plan

Comparison of two anesthetics protocol

Drug

Comparison of two anesthetics protocol

Primary outcomes

  1. Time from discontinuing anesthesia and extubation.

    Time frame: during 24 hours

Secondary outcomes

  1. Speed of emergence from anesthesia : time from discontinuing anesthesia to spontaneous breathing, opening the eyes, response to simple order and discharge from postoperative care unit.

    Time frame: during 24 hours

  2. Quality of emergence from anesthesia : agitation, postoperative pain, nausea and vomiting, cognitive functions.

    Time frame: during 24 hours

  3. Quality of surgical procedure : Coma glasgow scale, surgical procedure difficulties.

    Time frame: during 24 hours

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Anaesthesia for Supratentorial Tumor Resection : a Double-blind Comparison of Target Plasma Concentration of Propofol-remifentanil and Sevoflurane-sufentanil

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
Oct 19, 2006
Registry last updated
Jul 10, 2012

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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