Clinical trial NCT00389883: Anaesthesia for Supratentorial Tumor Resection
Official title: Anaesthesia for Supratentorial Tumor Resection : a Double-blind Comparison of Target Plasma Concentration of Propofol-remifentanil and Sevoflurane-sufentanil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Supratentorial Neoplasms
Keywords: supratentorial brain tumors
propofol
sevoflurane
remifentanil
sufentanil.
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2006-10-19
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time from discontinuing anesthesia and extubation.
timeFrame: during 24 hours
Secondary outcomes:
measure: 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.
timeFrame: during 24 hours
measure: Quality of emergence from anesthesia : agitation, postoperative pain, nausea and vomiting, cognitive functions.
timeFrame: during 24 hours
measure: Quality of surgical procedure : Coma glasgow scale, surgical procedure difficulties.
timeFrame: during 24 hours
Other outcomes:
Locations:
city: Besancon
country: France
facility: Centre Hospitalier Universitaire.
city: Clichy
country: France
facility: Hopital BEAUJON ASSISTANCE PUBLIQUE
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Souhayl DAHMANI, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Todd MM, Warner DS, Sokoll MD, Maktabi MA, Hindman BJ, Scamman FL, Kirschner J. A prospective, comparative trial of three anesthetics for elective supratentorial craniotomy. Propofol/fentanyl, isoflurane/nitrous oxide, and fentanyl/nitrous oxide. Anesthesiology. 1993 Jun;78(6):1005-20. doi: 10.1097/00000542-199306000-00002.
citation: Necib S, Tubach F, Peuch C, LeBihan E, Samain E, Mantz J, Dahmani S; PROMIFLUNIL trial group. Recovery from anesthesia after craniotomy for supratentorial tumors: comparison of propofol-remifentanil and sevoflurane-sufentanil (the PROMIFLUNIL trial). J Neurosurg Anesthesiol. 2014 Jan;26(1):37-44. doi: 10.1097/ANA.0b013e31829cc2d6.