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How Fast Are we? Speed of General Versus Spinal Anesthesia for Emergency Cesarean Delivery: A Simulation Based Study

14. marts 2014 opdateret af: University of British Columbia

Speed of General Versus Spinal Anesthesia for Emergency Cesarean Delivery: A Simulation Based Study

The researchers wish to undertake a simulation based study to compare the speed of general versus spinal anesthesia for emergency cesarean delivery. Minutes may matter for the baby in an emergency. It is unknown which technique is quicker. Their hypothesis is that surgical anesthesia can be achieved as quickly with spinal as with general anesthesia.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Rapid delivery of the fetus by emergency cesarean delivery is usually necessary when there is risk to mother or fetus (1). Some maternal indications for emergency cesarean delivery include uncontrolled bleeding, high spinal block and cardiac arrest. For the fetus, minutes may count when there are abnormal fetal heart rate patterns such as accompanying uterine rupture or umbilical cord prolapse. Under these emergency circumstances published recommendations include that delivery should occur within 30 minutes from decision time (2). Thus, the time taken to achieve surgical anesthesia is important and should be kept as short as possible to minimize risk to the fetus (3).

In the absence of a pre-existing labor epidural that can be rapidly extended for anesthesia, general (GA) or spinal (SA) anesthesia are usually administered to facilitate delivery in the urgent/emergent situation. Each technique has risks and benefits, but the choice of anesthesia will ultimately depend upon the circumstances. For example, severe maternal bleeding would favor GA because it is perceived to be quicker (although there are no studies to confirm this) and uncontrolled hemorrhage can produce hemodynamic instability which can be exacerbated by SA. On the other hand, known reactions to anesthetic agents (such as malignant hyperthermia) would make SA more favorable.

There is a perception amongst anesthesiologists that GA in pregnant women is associated with increased morbidity and mortality. This is partly due to the increased use of regional anesthesia since the 1960s and the uncommon occurrence of general anesthesia has lead to increased incidence of complications worldwide (4, 5). The reasons for this relate to the physiological changes of pregnancy which can make endotracheal intubation more difficult, increase the risk of pulmonary aspiration of stomach contents and awareness of intraoperative events (6, 7). These potential risks mean that fewer general anesthetics for cesarean delivery are being done while numbers of central neuraxial blocks (spinal, epidural) have increased. This means that anesthesiologists are less experienced in general anesthesia for obstetrics (8, 9). As well, at delivery the infant is more likely to be initially depressed and require active resuscitation than those delivered by SA (10). The depression is due not only to the GA but also to the reason for rapid delivery, for example cord prolapse causing fetal distress.

Apart from avoiding the risks of GA, SA has the added advantage that the parturient is awake when the infant is born and can be accompanied by their partner in the OR. As morphine is given with the spinal medication the women will generally have less pain post-operatively as well as being clear minded. However, occasionally SA can fail necessitating a GA.

It is unknown which technique is quicker. Some anesthesiologists believe that SA can be administered as quickly as GA and will often persist in administering SA for fear of the risks of general anesthesia. However, after induction of general anesthesia and endotracheal intubation, surgery can start immediately while with SA surgical anesthesia takes some time to develop after the anesthetic drugs are injected. There are no studies examining when surgery can actually start following SA and GA. Direct comparison of the two techniques under emergency situations based on a randomized control trial is impossible due to problems obtaining consent in that emergency situation where minutes count. Marx et al found that spinal anesthesia can be induced as quickly as GA, but the spinal needle used was bigger and the drug used (amethocaine) is not commonly used in modern practice (11).

Simulation of emergency scenarios allows anesthesiologists to practice safe emergency anesthesia (12). In a pilot simulation study insertion of SA was found to be as quick as GA, but the time to achieve surgical anesthesia was longer (13). Thus, the overall time between inducing anesthesia and the time when surgery could actually start was longer with SA.

We wish to undertake a simulation based study to compare the speed of GA versus SA for emergency cesarean delivery. We also wish to observe the techniques anesthesiologists use to expedite readiness to surgical anesthesia. At the conclusion of this study, we hope to help the anesthesiologist decide upon the optimum technique of anesthesia for emergency cesarean delivery and so affect fetal and maternal outcome.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

19

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • British Columbia
      • Vancouver, British Columbia, Canada, V6N 3N1
        • BC Women's Hospital & Health Care

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Consenting anesthesiologists, R5 residents and anesthesia fellows practicing at BC Women's Hospital.

Beskrivelse

Inclusion Criteria:

  • Consenting anesthesiologists,
  • R5 residents and anesthesia fellows practicing at BC Women's Hospital

Exclusion Criteria:

-

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
1
Observational study comparing the speed of general versus spinal anesthesia during emergency cesarean
How long anesthesiologists take to administer general and spinal anesthesia.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Vit Gunka, Dr., University of British Columbia
  • Studieleder: Arry Kathirgamanathan, Dr., University of British Columbia
  • Studieleder: Roanne Preston, Dr., University of British Columbia
  • Studieleder: Jessica Tyler, Ms., University of British Columbia

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2009

Primær færdiggørelse (Faktiske)

1. december 2009

Studieafslutning (Faktiske)

1. december 2009

Datoer for studieregistrering

Først indsendt

25. august 2009

Først indsendt, der opfyldte QC-kriterier

26. august 2009

Først opslået (Skøn)

27. august 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. marts 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. marts 2014

Sidst verificeret

1. marts 2014

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Anæstesi

Kliniske forsøg med Anesthesia

3
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