Evidence map›Paper›PMID 30704463›Full record

Trial reportBMC anesthesiology2019

Effects of bupivacaine or levobupivacaine on cerebral oxygenation during spinal anesthesia in elderly patients undergoing orthopedic surgery for hip fracture: a randomized controlled trial.

Roser Vives, Diana Fernandez-Galinski, Francisca Gordo, Alberto Izquierdo, Joan C Oliva, Carmen Colilles, Caridad Pontes

Registry-linked trialOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC anesthesiology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01960543 (Comparison of the Effects of Bupivacaine or Levobupivacaine on Cerebral Oxygenation During Intrathecal Anesthesia in Elderly Patients Who Underwent Hip Fracture Repair), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01960543 phase4completednot on this map

Comparison of the Effects of Bupivacaine or Levobupivacaine on Cerebral Oxygenation During Intrathecal Anesthesia in Elderly Patients Who Underwent Hip Fracture Repair

TypeinterventionalSponsorCorporacion Parc TauliRan2013 to 2014Enrolled58ConditionsComplication of AnesthesiaArmsfentanyl 15 microg, Bupivacaine 7 mg, Bupivacaine 9 mg, Levobupivacaine 7 mg, Levobupivacaine 9 mg
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Roser VivesDepartament de Farmacologia, de Terapèutica i de Toxicologia, UAB, Clinical Pharmacology Unit, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Parc Taulí 1, 08028, Sabadell (Barcelona), Spain. Roser.vives@uab.cat.ORCID 0000-0002-4369-778X
Diana Fernandez-GalinskiAnesthesiology Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Parc Taulí 1, 08028, Sabadell (Barcelona), Spain.
Francisca GordoAnesthesiology Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Parc Taulí 1, 08028, Sabadell (Barcelona), Spain.
Alberto IzquierdoAnesthesiology Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Parc Taulí 1, 08028, Sabadell (Barcelona), Spain.
Joan C OlivaStatistics Unit, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Parc Taulí 1, 08028, Sabadell (Barcelona), Spain.
Carmen ColillesAnesthesiology Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Parc Taulí 1, 08028, Sabadell (Barcelona), Spain.
Caridad PontesDepartament de Farmacologia, de Terapèutica i de Toxicologia, UAB, Clinical Pharmacology Unit, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Parc Taulí 1, 08028, Sabadell (Barcelona), Spain.
Universitat Autònoma de Barcelona · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBupivacaine and levobupivacaine have similar pharmacokinetic and pharmacodynamic characteristics, and are used regularly in spinal anesthesia. Whether potential differences in their hemodynamic and anesthetic profiles could determine a differential risk of complications in elderly subjects, is controversial. The main objective was to compare the effects of intrathecally administered levobupivacaine (LB) versus bupivacaine (B), on regional cerebral O

methodsThis was a randomized, controlled, single blind study. 58 patients aged 70 or older undergoing surgery for hip fracture with spinal anesthesia were allocated with a 1:1 ratio to receive LB or B, combined with fentanyl 15 μg, by intrathecal route. The primary outcome was the proportion of intraoperative time with regional cerebral desaturation (≥20% reduction in regional cerebral oxygen saturation from baseline), monitored by near -infrared spectroscopy. Secondary endpoints included hemodynamic parameters, level of sensory and motor block, changes in Short Portable Mental Status Questionnaire (SPMSQ), and neurological complications.

resultsThe mean percentage of intraoperative time with desaturation in the B group was 6.1% (SD: 17.5) and 4.7% (SD: 11.9) in the left and right hemisphere respectively; in the LB group the mean was 4.8% (SD: 11.4) in the left hemisphere and 2.4% (SD: 8.3) in the right one. No statistically significant differences were found between treatment groups. The level of sensory block at the start of surgery was lower for LB than for B (Th10 vs Th8, p:0.047) and motor block at 15 min was lower for LB (2.5 vs 3, p:0.009). No differences in postoperative SPMSQ were observed. Neurological complications such as confusional state, agitation or disorientation were reported in 50% of patients in the B group and 21.4% of patients in the LB group, p = 0.05.

conclusionsNo statistically significant differences in regional cerebral oxygen saturation or hemodynamic parameters were observed between both treatment groups. Bupivacaine and levobupivacaine differed in sensory and motor block achieved. While no differences were observed in cognitive impairment measured by the SPMSQ between treatment groups neurological complications reported by the physician were more frequent with bupivacaine.

trial registrationEuropean Union Clinical Trials Register ( EudraCT 2013-000846 -20 ) (April 9th, 2013). ClinicalTrials.gov ( NCT01960543 ) (September 23rd, 2013).

Indexed as

AgedAged, 80 and overAnesthesia, SpinalAnesthetics, LocalBupivacaineFemaleFentanylHip FracturesHumansInjections, SpinalLevobupivacaineMaleOrthopedic ProceduresOxygenSingle-Blind MethodAnesthetics, LocalBupivacaineFentanylLevobupivacaineOxygenBupivacaineLevobupivacaineRegional cerebral oxygen saturationSpinal anesthesia

Identifiers

PMID30704463
PMCPMC6357488
OpenAlexW2911991559

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.