AzTrials
AzTrials

AnesthesiaNCT00966680

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

An observational study of Anesthesia, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Anesthesia
What is being tested?
Anesthesia
How many people
19 participants
Where
1 siteCanada
Study dates
Sep 2009to Dec 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • BC Women's Hospital & Health Care

    Vancouver, British Columbia, V6N 3N1

Other trials in Canada

About this study

Official title: 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.

Read the detailed description

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.

Conditions
Anesthesia
Being tested
Anesthesia
Keywords
general anesthesia, spinal anesthesia, emergency cesarean delivery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnesthesiaOther

    How long anesthesiologists take to administer general and spinal anesthesia.

Study groups in NCT00966680
Study groupRoleWhat they receive
1Observational study comparing the speed of general versus spinal anesthesia during emergency cesarean
Receives: Other: Anesthesia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionDec 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00966680
Sponsor's protocol ID
H09-01465
Status last verified
Mar 2014
First submitted
25 Aug 2009
Last updated
17 Mar 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2014.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in